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| ID | Type | Description | Link |
|---|---|---|---|
| 16-C-0107 |
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Background: EP0057 (formerly CRLX101) consists of a sugar molecule cyclodextrin linked to a chemotherapy drug called camptothecin. The combined molecule or "nanoparticle drug conjugate" travels through the blood. Once inside cancer cells, the chemotherapy drug is released from the molecule. Olaparib is a drug that may stop cancer cells from repairing the deoxyribonucleic acid (DNA) damage caused by chemotherapy. Researchers want to see how safe it is to give EP0057 and olaparib together and to see how well the combination treats a specific type of lung cancer called small cell lung cancer (SCLC).
Objectives:
To test the safety and maximum dose of EP0057 and olaparib together. To test how well they treat small cell lung cancer.
Eligibility:
Adults 18 and older with small cell lung cancer.
Design:
Participants will be screened with standard cancer care tests.
Participants will get the 2 study drugs in 28-day cycles. EP0057 will be given every 2 weeks, through a small plastic tube in an arm vein. Olaparib will be taken by mouth twice a day most days. Participants will keep a pill diary.
For Cycle 1, participants will have 3 visits. All other cycles will have 2 visits.
At study visits, participants may have:
Participants will have a follow-up visit 4 weeks after finish taking the drugs. They will have a physical exam and blood tests. They may have a tumor biopsy. The study team will call the patient every 3 months for follow up after completing the study treatment.
Background:
Objectives:
Eligibility:
Phase I
Phase II
Phase II Expansion Cohorts
Design:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1/Phase I - EP0057 (formerly CRLX101) + Olaparib | Experimental | EP0057 + olaparib |
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| 2/Phase II - EP0057 + Olaparib at Maximum Tolerated Dose/Recommended Phase 2 Dose (MTD/RP2D) | Experimental | EP0057 (formerly CRLX101) + olaparib at maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EP0057 | Drug | EP0057 (formerly CRLX101) intravenous (IV) every (Q) 2weeks Day 1 and Day 15, administered in 28-day cycles, until disease progression or development of intolerable side effects. Plus olaparib (by mouth (PO) days 3-13* and days 17-26*) administered in 28-day cycles, until disease progression or development of intolerable side effects. Phase (P)1: Dose Escalation P2: recommended phase 2 dose (RP2D). (* On days 13 and 26, only one dose of olaparib will be administered in the morning) |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of EP0057 (CLRX101) in Participants With Refractory Cancers. | MTD/RP2D is the dose level at which no more than 1 of up to 6 participants experience dose-limiting toxicity (DLT) during the DLT evaluation period, and the dose below that at which at least 2 (of ≤6) participants have DLT as a result of the drug. DLTs will be defined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (Version 4). The following toxicities, occurring during cycle 1 of the study combination, will be considered DLTs if deemed drug-related: Grade 4 neutropenia complicated by fever ≥38.5C and/or documented infection; Grade 4 neutropenia that does not resolve within 7 days; Grade 4 thrombocytopenia that does not resolve within 7 days or grade 3-4 thrombocytopenia complicated with hemorrhage. Grade 4 anemia that does not resolve within 7 days despite optimal therapy; and inability to begin subsequent treatment course within 28 days of the scheduled date, due to study drug toxicity. | First 28 days |
| Phase I: Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of Olaparib in Participants With Refractory Cancers. | MTD/RP2D is the dose level at which no more than 1 of up to 6 participants experience dose-limiting toxicity (DLT) during the DLT evaluation period, and the dose below that at which at least 2 (of ≤6) participants have DLT as a result of the drug. DLTs will be defined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (Version 4). The following toxicities, occurring during cycle 1 of the study combination, will be considered DLTs if deemed drug-related: Grade 4 neutropenia complicated by fever ≥38.5C and/or documented infection; Grade 4 neutropenia that does not resolve within 7 days; Grade 4 thrombocytopenia that does not resolve within 7 days or grade 3-4 thrombocytopenia complicated with hemorrhage. Grade 4 anemia that does not resolve within 7 days despite optimal therapy; and inability to begin subsequent treatment course within 28 days of the scheduled date, due to study drug toxicity. | First 28 days |
| Number of Dose Limiting Toxicities (DLTs) During the First Cycle | DLTs will be defined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (Version 4). The following toxicities, occurring during cycle 1 of the study combination, will be considered DLTs if deemed drug-related: Grade 4 neutropenia complicated by fever ≥38.5C and/or documented infection; Grade 4 neutropenia that does not resolve within 7 days; Grade 4 thrombocytopenia that does not resolve within 7 days or grade 3-4 thrombocytopenia complicated with hemorrhage. Grade 4 anemia that does not resolve within 7 days despite optimal therapy; and inability to begin subsequent treatment course within 28 days of the scheduled date, due to study drug toxicity, and any Grade 3-4 non-hematologic toxicity except fatigue/asthenia <2 weeks in duration). |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts | Occurrence is captured by subjective and objective data via participant assessment ad self-report. Toxicities including toxicity type and severity (Grades 1, 2, 3, and/or 4) with probable association to study regimen in participants on Expansion cohorts was measured by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
INCLUSION CRITERIA: - Phase I
Patients must have histologically or cytologically confirmed advanced solid tumor that is resistant or refractory to standard therapy.
A minimum of 2 weeks will be required from any prior therapy, including chemotherapy, immunotherapy and/or radiation. In addition, recovery to Grade <= 1 from all reversible toxicities related to prior therapy is required at study entry.
Patients do not need to have measurable disease to enroll on phase I.
Age 18 years.
Eastern cooperative Oncology Group (ECOG) performance status <=2
Patients with treated brain metastases (surgery, whole or stereotactic brain radiation) are allowed provided the lesions have been stable for at least 2 weeks and the patient is off steroids or is on a stable dose of steroids. Patients with brain metastases should not require use of enzyme-inducing antiepileptic drugs (e.g., carbamazepine, phenytoin, or phenobarbital) within 14 days before first dose and during study. Use of newer antiepileptics that do not produce enzyme induction drug-drug interactions (DDIs) is allowed.
Patients must have normal organ and marrow function as defined below:
OR
OR
creatinine clearance >= 51 mL/min (calculated using the Cockroft-Gault formula) for patients with creatinine levels above institutional normal.
-The effects of EP0057 (formerly CRLX101) and olaparib on the developing human fetus are unknown. For this reason and because these agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 120 days (both male and female) following last dose of study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Fertile females of childbearing potential are defined as women physically capable of becoming pregnant unless the female patient cannot have children because of surgery or other medical reasons (effective tubal ligation, ovaries or the uterus removed, or are post-menopausal). Post-menopausal is defined as:
Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments,
Luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range for women under 50,
radiation-induced oophorectomy with last menses >1 year ago,
chemotherapy-induced menopause with >1 year interval since last menses,
or surgical sterilization (bilateral oophorectomy or hysterectomy).
INCLUSION CRITERIA: - Phase II Small Cell Lung Cancer (SCLC)
Age >=18 years.
Patients must have histologically or cytologically confirmed diagnosis of SCLC from a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.
Have received and progressed during or after a platinum-based standard chemotherapy regimen and/or an immune-checkpoint inhibitor
Patients could have received any number of therapies for relapsed or progressive disease, including re-treatment with original frontline regimen. A minimum of 2 weeks will be required from any prior therapy, including chemotherapy, immunotherapy and/or radiation. In addition, recovery to Grade <= 1 from all reversible toxicities related to prior therapy is required at study entry. No previous irradiation to the site of measurable or evaluable disease, unless that site had subsequent evidence of progression.
Patients must have measurable disease as per Response Evaluation Criteria in Solid Tumors, version (RECIST 1.1).
Radiographic evidence of disease progression after initial therapy should have been documented.
Eastern Cooperative Oncology Group (ECOG) performance status <=2.
Patients with treated brain metastases (surgery, whole or stereotactic brain radiation) are allowed provided the lesions have been stable for at least 2 weeks and the patient is off steroids or is on a stable dose of steroids. Patients with brain metastases should not require use of enzyme-inducing antiepileptic drugs (e.g., carbamazepine, phenytoin, or phenobarbital) within 14 days before first dose and during study. Use of newer antiepileptics that do not produce enzyme induction drug-drug interactions (DDIs) is allowed.
Patients must have normal organ and marrow function as defined below:
OR
OR
creatinine clearance >=51 mL/min (calculated using the Cockroft-Gault formula) for patients with creatinine levels above institutional normal.
LH and FSH levels in the post-menopausal range for women under 50,
radiation-induced oophorectomy with last menses >1 year ago,
chemotherapy-induced menopause with >1 year interval since last menses,
or surgical sterilization (bilateral oophorectomy or hysterectomy).
INCLUSION CRITERIA: for Urothelial Carcinoma Expansion Cohort (accrual to the cohort ended with amendment version 08/17/2022)
Patients must have a histologically confirmed diagnosis of urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis from a CLIA-certified laboratory, with measurable disease by RECIST (version 1.1) including lymphadenopathy and visceral metastatic disease
Male or female patients >= 18 years of age.
Patient must have received at least one platinum-based regimen of chemotherapy and/or an immune-checkpoint inhibitor if appropriate with progressive disease.
Prior antiangiogenic and radiation therapy are permitted (2-week washout from therapy is required).
Bisphosphonates and denosumab are permitted if on a stable dose for >=4 weeks.
ECOG 0-2
OR
hemoglobin >10 g/dL, and no blood transfusion within 2 weeks.
total bilirubin<TAB> <=1.5 x ULN (unless Gilbert's Disease)
AST(SGOT)/ALT(SGPT) <=2.5 X institutional upper limit of normal (<= 5X ULN if liver mets)
creatinine <= ULN
-The effects of EP0057 and olaparib on the developing human fetus are unknown. For this reason and because these agents are known to be teratogenic, women of child-bearing potential and men must agree to use highly effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 120 days (both male and female) following last dose of study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Fertile females of childbearing potential are defined as women physically capable of becoming pregnant unless the female patient cannot have children because of surgery or other medical reasons (effective tubal ligation, ovaries or the uterus removed, or are post-menopausal). Post-menopausal is defined as:
Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments,
LH and FSH levels in the post-menopausal range for women under 50,
radiation-induced oophorectomy with last menses >1 year ago,
chemotherapy-induced menopause with >1 year interval since last menses,
or surgical sterilization (bilateral oophorectomy or hysterectomy).
INCLUSION CRITERIA for mCRPC Expansion Cohort (accrual to the mCRPC cohort ended with amendment version 7/27/2021)
Patients must have metastatic, progressive, castrate resistant prostate cancer (mCRPC).
Documented histopathological confirmation of prostate cancer from a CLIA-certified laboratory.
All patients must have at least one lesion deemed safe to biopsy and be willing to undergo a mandatory baseline biopsy.
Patients must have received prior treatment with enzalutamide and/or abiraterone with the exception of patients who were treated with docetaxel and androgen deprivation therapy for metastatic castrate-sensitive prostate cancer and progressed on docetaxel treatment or who progress within one month of the last docetaxel dose.
Patients must have castrate levels of testosterone (<50 ng/dl [1.74 nmol/l])
Patients must have undergone bilateral surgical castration or must agree to continue on gonadotropin-releasing hormone (GnRH) agonists/antagonists for the duration of the study.
ECOG performance status <= 2
Patients must have adequate bone marrow, hepatic, and renal function with:
OR
OR
--creatinine clearance >=51 mL/min (calculated using the Cockroft-Gault formula) for patients with creatinine levels above institutional normal.
Patients who were treated for metastatic castrate-sensitive prostate cancer with docetaxel and androgen deprivation therapy who progress on docetaxel treatment or who progress within one month of the last docetaxel dose are eligible.
EXCLUSION CRITERIA: - Phase I and II SCLC and UC Expansion Cohort (note: accrual to the UC cohort ended with amendment version 08/17/2022)
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| Name | Affiliation | Role |
|---|---|---|
| Anish Thomas, M.D. | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32897402 | Derived | Schmidt KT, Huitema ADR, Dorlo TPC, Peer CJ, Cordes LM, Sciuto L, Wroblewski S, Pommier Y, Madan RA, Thomas A, Figg WD. Population pharmacokinetic analysis of nanoparticle-bound and free camptothecin after administration of NLG207 in adults with advanced solid tumors. Cancer Chemother Pharmacol. 2020 Oct;86(4):475-486. doi: 10.1007/s00280-020-04134-9. Epub 2020 Sep 8. |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. In addition, all large-scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).
Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol Genomic Data Sharing (GDS) plan for as long as database is active.
Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI). Genomic data are made available via the database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.
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| ID | Title | Description |
|---|---|---|
| FG000 | Solid Tumor Dose Level 1: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 100mg (by Mouth) | "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 100mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 11, 2025 |
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| olaparib | Drug | Olaparib (by mouth (PO) days 3-13* and days 17-26* administered in 28-day cycles, until disease progression or development of intolerable side effects Plus EP0057 (formerly CRLX101) (intravenous (IV) every (Q) 2 weeks, Day 1 and Day 15) administered in 28-day cycles, until disease progression or development of intolerable side effects. Phase (P)1: Dose Escalation P2: recommended phase 2 dose (RP2D). (* On days 13 and 26, only one dose of olaparib will be administered in the morning). |
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| CT scan | Diagnostic Test | Screening and baseline. |
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| CT chest, abdomen, and pelvis | Diagnostic Test | Metastatic castration-resistant prostate cancer (mCRPC) participants only at screening, baseline, cycle 2 Day 1, and end of treatment/disease progression. |
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| Bone scan | Diagnostic Test | Metastatic castration-resistant prostate cancer (mCRPC) participants only at screening, baseline, cycle 2 Day 1, and end of treatment/disease progression. |
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| ECG | Diagnostic Test | Screening, baseline, Day 1, Day 15 and cycle 2, Day 1. |
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| Echocardiogram | Diagnostic Test | At screening. |
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| Biopsy | Procedure | Baseline Day 4 and end of treatment/disease progression. |
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| First 28 days |
| Expansion: Progression Free Survival (PFS) Rate in the Combination of Olaparib Plus EP0057 (CLRX101) at 16 Weeks in Small Cell Lung Cancer (SCLC) Participants | Determine if slightly more than 50% of participants may be identified as being without progression by 16 weeks. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions. Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. | 16 weeks |
| Expansion: Overall Response Rate (Complete Response (CR) + Partial Response (PR) of EP0057 (CLRX101) Plus Olaparib in Participants With Urothelial Carcinoma | Overall response rate is the best response recorded from the start of the treatment until disease progression/recurrence. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions. Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. | 8 weeks |
| Expansion: Overall Response Rate (Complete Response (CR) + Partial Response (PR) of EP0057 (CLRX101) Plus Olaparib in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) | Determine if slightly more than 50% of participants may be identified as being without progression by 12 weeks. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions. Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. | 12 weeks |
| Start of treatment through 30 days post last dose, an average of 8.26 months. |
| Progression-free Survival (PFS) on Expansion Cohorts | PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions. | Every 3 months post-treatment, up until date of death from any cause or an average of 9.57 months. |
| Progression-free Survival (PFS) of the Combination | PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions. | Duration of time from start of treatment to time of progression or death, whichever occurs first, up to 2.5 years |
| Overall Survival (OS) of the Combination | OS is defined as the date of on-study to the date of death from any cause or last follow up. | Date of on-study to the date of death from any cause or last follow up, up to 2.5 years |
| Prostate-specific Antigen (PSA) on Metastatic Castration-Resistant Prostate Cancer (mCRPC) Expansion Cohort Reported at Time of Documented Partial Response (PR) With an 80% Confidence Interval | PSA levels in blood, date of cycle 1, Day 1 (C1D1) - Best response date. PSA levels were measured by the Enzyme-Linked Immunosorbent Assay (ELISA). Normal PSA level is ≤6.5 ng/mL for age 70-79 and an elevated level is not interpreted good or bad; a very high number is a strong indicator of prostate cancer; since this is a cohort of prostate cancer an elevated number is expected. Partial Response was assessed by the Response Evaluation Criteria in Solid Tumors in Solid Tumors (RECIST) guideline (version 1.1) and Prostate Cancer Clinical Trials Working Group criteria (PCWG2). Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. | 40.71 weeks from start of treatment to best response date |
| Prostate-specific Antigen (PSA) on Metastatic Castration-Resistant Prostate Cancer (mCRPC) Expansion Cohort Reported at Time of Documented Partial Response (PR) an 95% Confidence Interval | PSA levels in blood were measured by the Enzyme-Linked Immunosorbent Assay (ELISA). Normal PSA level is ≤6.5 ng/mL for age 70-79 and an elevated level is not interpreted good or bad; a very high number is a strong indicator of prostate cancer; since this is a cohort of prostate cancer an elevated number is expected; it is noted that this number is decreased from the start of therapy. Partial Response was assessed by the Response Evaluation Criteria in Solid Tumors in Solid Tumors (RECIST) guideline (version 1.1) and Prostate Cancer Clinical Trials Working Group criteria (PCWG2). Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. | 40.71 weeks from start of treatment to best response date. |
| Duration of Response (DOR) of the Combination | DOR is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. OS is determined from the start of treatment until death. Response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions. | At baseline and after every 2 cycles up until the date of first documented progression or an average of average 11.09 months. |
| Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts | Occurrence is captured by subjective and objective data via participant assessment and self-report. Toxicities including toxicity type and severity (Grades 1, 2, 3, and/or 4) with probable association to study regimen in participants on Expansion cohorts was measured by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to adverse event (AE). | Start of treatment through 30 days post last dose, up to 3.99 months |
| Maximum Observed Plasma Concentration of EP0057 (Both the Total Drug and Released Camptothecin) and Olaparib | Blood samples for pharmacokinetic (PK) analysis were collected at pre-dose, mid-infusion (30 minutes), end of infusion (EOI), and 1, 2, 12, 24, and 48 hours (hr) post-EOI. Samples were drawn into sodium heparin tubes, processed to plasma, and stored at -80°C. On Cycle 6 Day 1 (C6D1), additional samples were collected to evaluate EP0057 (CLRX101) accumulation and potential drug interactions. Total plasma concentrations of released camptothecin (CPT) were measured after acidification with 0.1 normality (N) hydrochloric acid (HCl) to stabilize the lactone form, followed by dilution and Ultra-Performance Liquid Chromatography-Tandem Mass Spectrometry, (UPLC-MS/MS) analysis. Noncompartmental analysis was used to calculate PK parameters. Concentrations below lower limit of quantification (LLOQ) was excluded. Maximum serum concentration (CMAX) values were recorded as observed. | Cycle 1 (pre-dose, mid-infusion (30 minutes), end of infusion (EOI), and 1, 2, 12, 24, and 48 hours (hr) post-EOI); and Cycle 6 Day 1. |
| Mean Change From Baseline γ- H2A Histone Family Member X (H2AX) Intensity in Plucked Hair Follicles | Mean of each participant's value of baseline γH2AX intensity in plucked hair follicles after receiving the drug. The mean change of each participant would be calculated from available hair follicles (or eyebrows if scalp hairs are unobtainable) that contain a full intact follicle and sheath were collected (i.e., plucked) from participants scalp with forceps. Hair follicles were fluorescently stained for γ- H2A histone family member X (H2AX) analysis. | 4 days |
| Pharmacodynamic (PD) Activity of EP0057 in Tumor Biopsy Specimens | Drug concentrations in tumor specimens. | Baseline, Cycle 1, then every 2 cycles, and at progression |
| Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. |
| FG001 | Solid Tumor Dose Level 2: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 150mg (by Mouth) | "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 150mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| FG002 | Solid Tumor Dose Level 3: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 200mg (by Mouth) | "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 200mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| FG003 | Solid Tumor Dose Level 4: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 300mg (by Mouth) | "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 300mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| FG004 | Solid Tumor Dose Level 4R: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 250mg (by Mouth) | "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| FG005 | Small Cell Lung Cancer Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) | "Small cell lung cancer (SCLC) patients with resistant or sensitive relapse; EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| FG006 | Urothelial Carcinoma Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) | "Confirmed diagnosis of urothelial. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| FG007 | Metastatic Castration-Resistant Prostate Cancer Dose Level 4R: EP0057 12mg/m^2; Olaparib 250mg | "Confirmed diagnosis of metastatic, progressive, castrate resistant prostate cancer (mCRPC). Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
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| ID | Title | Description |
|---|---|---|
| BG000 | Solid Tumor Dose Level 1: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 100mg (by Mouth) | "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 100mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| BG001 | Solid Tumor Dose Level 2: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 150mg (by Mouth) | "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 150mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| BG002 | Solid Tumor Dose Level 3: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 200mg (by Mouth) | "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 200mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| BG003 | Solid Tumor Dose Level 4: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 300mg (by Mouth) | "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 300mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| BG004 | Solid Tumor Dose Level 4R: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 250mg (by Mouth) | "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| BG005 | Small Cell Lung Cancer Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) | "Small cell lung cancer (SCLC) patients with resistant or sensitive relapse; EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| BG006 | Urothelial Carcinoma Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) | "Confirmed diagnosis of urothelial. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| BG007 | Metastatic Castration-Resistant Prostate Cancer Dose Level 4R: EP0057 12mg/m^2; Olaparib 250mg | "Confirmed diagnosis of metastatic, progressive, castrate resistant prostate cancer (mCRPC). Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| BG008 | Total | Total of all reporting groups |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
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| Primary | Phase I: Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of EP0057 (CLRX101) in Participants With Refractory Cancers. | MTD/RP2D is the dose level at which no more than 1 of up to 6 participants experience dose-limiting toxicity (DLT) during the DLT evaluation period, and the dose below that at which at least 2 (of ≤6) participants have DLT as a result of the drug. DLTs will be defined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (Version 4). The following toxicities, occurring during cycle 1 of the study combination, will be considered DLTs if deemed drug-related: Grade 4 neutropenia complicated by fever ≥38.5C and/or documented infection; Grade 4 neutropenia that does not resolve within 7 days; Grade 4 thrombocytopenia that does not resolve within 7 days or grade 3-4 thrombocytopenia complicated with hemorrhage. Grade 4 anemia that does not resolve within 7 days despite optimal therapy; and inability to begin subsequent treatment course within 28 days of the scheduled date, due to study drug toxicity. | Posted | Number | mg/m^2 | First 28 days |
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| Primary | Phase I: Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of Olaparib in Participants With Refractory Cancers. | MTD/RP2D is the dose level at which no more than 1 of up to 6 participants experience dose-limiting toxicity (DLT) during the DLT evaluation period, and the dose below that at which at least 2 (of ≤6) participants have DLT as a result of the drug. DLTs will be defined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (Version 4). The following toxicities, occurring during cycle 1 of the study combination, will be considered DLTs if deemed drug-related: Grade 4 neutropenia complicated by fever ≥38.5C and/or documented infection; Grade 4 neutropenia that does not resolve within 7 days; Grade 4 thrombocytopenia that does not resolve within 7 days or grade 3-4 thrombocytopenia complicated with hemorrhage. Grade 4 anemia that does not resolve within 7 days despite optimal therapy; and inability to begin subsequent treatment course within 28 days of the scheduled date, due to study drug toxicity. | Posted | Number | mg | First 28 days |
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| Primary | Number of Dose Limiting Toxicities (DLTs) During the First Cycle | DLTs will be defined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (Version 4). The following toxicities, occurring during cycle 1 of the study combination, will be considered DLTs if deemed drug-related: Grade 4 neutropenia complicated by fever ≥38.5C and/or documented infection; Grade 4 neutropenia that does not resolve within 7 days; Grade 4 thrombocytopenia that does not resolve within 7 days or grade 3-4 thrombocytopenia complicated with hemorrhage. Grade 4 anemia that does not resolve within 7 days despite optimal therapy; and inability to begin subsequent treatment course within 28 days of the scheduled date, due to study drug toxicity, and any Grade 3-4 non-hematologic toxicity except fatigue/asthenia <2 weeks in duration). | Only 23/45 participants were analyzed because DLTs are only completed during phase I. There were only 23 participants in phase I. | Posted | Number | toxicities | First 28 days |
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| Primary | Expansion: Progression Free Survival (PFS) Rate in the Combination of Olaparib Plus EP0057 (CLRX101) at 16 Weeks in Small Cell Lung Cancer (SCLC) Participants | Determine if slightly more than 50% of participants may be identified as being without progression by 16 weeks. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions. Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. | 10/13 participants with small cell lung cancer were analyzed because PFS was only calculated for evaluable participants. | Posted | Count of Participants | Participants | 16 weeks |
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| Primary | Expansion: Overall Response Rate (Complete Response (CR) + Partial Response (PR) of EP0057 (CLRX101) Plus Olaparib in Participants With Urothelial Carcinoma | Overall response rate is the best response recorded from the start of the treatment until disease progression/recurrence. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions. Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. | 3/4 participants with urothelial carcinoma were analyzed because only 3 of the 4 participants were evaluable; to analyze a response you can only use evaluable participants. | Posted | Count of Participants | Participants | 8 weeks |
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| Primary | Expansion: Overall Response Rate (Complete Response (CR) + Partial Response (PR) of EP0057 (CLRX101) Plus Olaparib in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) | Determine if slightly more than 50% of participants may be identified as being without progression by 12 weeks. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions. Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. | 3/4 participants with metastatic castration-resistant prostate cancer were analyzed because only 3 of the 4 participants were evaluable; to analyze a response you can only use evaluable participants. | Posted | Count of Participants | Participants | 12 weeks |
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| Secondary | Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts | Occurrence is captured by subjective and objective data via participant assessment ad self-report. Toxicities including toxicity type and severity (Grades 1, 2, 3, and/or 4) with probable association to study regimen in participants on Expansion cohorts was measured by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. | Posted | Number | toxicities | Start of treatment through 30 days post last dose, an average of 8.26 months. |
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| Secondary | Progression-free Survival (PFS) on Expansion Cohorts | PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions. | 16/21 participants in the expansion cohort were analyzed because this was the number of evaluable participants. | Posted | Median | Full Range | Months | Every 3 months post-treatment, up until date of death from any cause or an average of 9.57 months. |
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| Secondary | Progression-free Survival (PFS) of the Combination | PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions. | 18/24 participants with solid tumors were analyzed because these were the evaluable participants. | Posted | Median | Full Range | Months | Duration of time from start of treatment to time of progression or death, whichever occurs first, up to 2.5 years |
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| Secondary | Overall Survival (OS) of the Combination | OS is defined as the date of on-study to the date of death from any cause or last follow up. | 34/45 participants were analyzed because these were the evaluable participants. | Posted | Median | Full Range | Months | Date of on-study to the date of death from any cause or last follow up, up to 2.5 years |
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| Secondary | Prostate-specific Antigen (PSA) on Metastatic Castration-Resistant Prostate Cancer (mCRPC) Expansion Cohort Reported at Time of Documented Partial Response (PR) With an 80% Confidence Interval | PSA levels in blood, date of cycle 1, Day 1 (C1D1) - Best response date. PSA levels were measured by the Enzyme-Linked Immunosorbent Assay (ELISA). Normal PSA level is ≤6.5 ng/mL for age 70-79 and an elevated level is not interpreted good or bad; a very high number is a strong indicator of prostate cancer; since this is a cohort of prostate cancer an elevated number is expected. Partial Response was assessed by the Response Evaluation Criteria in Solid Tumors in Solid Tumors (RECIST) guideline (version 1.1) and Prostate Cancer Clinical Trials Working Group criteria (PCWG2). Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. | 1/4 participants were analyzed because they were not evaluable. | Posted | Number | 80% Confidence Interval | ng/mL | 40.71 weeks from start of treatment to best response date |
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| Secondary | Prostate-specific Antigen (PSA) on Metastatic Castration-Resistant Prostate Cancer (mCRPC) Expansion Cohort Reported at Time of Documented Partial Response (PR) an 95% Confidence Interval | PSA levels in blood were measured by the Enzyme-Linked Immunosorbent Assay (ELISA). Normal PSA level is ≤6.5 ng/mL for age 70-79 and an elevated level is not interpreted good or bad; a very high number is a strong indicator of prostate cancer; since this is a cohort of prostate cancer an elevated number is expected; it is noted that this number is decreased from the start of therapy. Partial Response was assessed by the Response Evaluation Criteria in Solid Tumors in Solid Tumors (RECIST) guideline (version 1.1) and Prostate Cancer Clinical Trials Working Group criteria (PCWG2). Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. | Posted | Number | 95% Confidence Interval | ng/mL | 40.71 weeks from start of treatment to best response date. |
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| Secondary | Duration of Response (DOR) of the Combination | DOR is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. OS is determined from the start of treatment until death. Response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions. | 5/45 participants were analyzed because only 5/45 participants were evaluable. | Posted | Median | Full Range | Months | At baseline and after every 2 cycles up until the date of first documented progression or an average of average 11.09 months. |
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| Secondary | Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts | Occurrence is captured by subjective and objective data via participant assessment and self-report. Toxicities including toxicity type and severity (Grades 1, 2, 3, and/or 4) with probable association to study regimen in participants on Expansion cohorts was measured by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to adverse event (AE). | Posted | Number | occurrences of toxicities | Start of treatment through 30 days post last dose, up to 3.99 months |
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| Secondary | Maximum Observed Plasma Concentration of EP0057 (Both the Total Drug and Released Camptothecin) and Olaparib | Blood samples for pharmacokinetic (PK) analysis were collected at pre-dose, mid-infusion (30 minutes), end of infusion (EOI), and 1, 2, 12, 24, and 48 hours (hr) post-EOI. Samples were drawn into sodium heparin tubes, processed to plasma, and stored at -80°C. On Cycle 6 Day 1 (C6D1), additional samples were collected to evaluate EP0057 (CLRX101) accumulation and potential drug interactions. Total plasma concentrations of released camptothecin (CPT) were measured after acidification with 0.1 normality (N) hydrochloric acid (HCl) to stabilize the lactone form, followed by dilution and Ultra-Performance Liquid Chromatography-Tandem Mass Spectrometry, (UPLC-MS/MS) analysis. Noncompartmental analysis was used to calculate PK parameters. Concentrations below lower limit of quantification (LLOQ) was excluded. Maximum serum concentration (CMAX) values were recorded as observed. | 24/45 participants were analyzed because pharmacokinetics for phase II was not collected. These were not collected for Ph II as they were in the study calendar of the protocol for Phase I. This outcome was only calculated for phase I solid tumors. 2/3 participants were analyzed in solid tumor dose level 1 because one participant was omitted due to incomplete serial PK collection. | Posted | Mean | Standard Deviation | Ng/mL | Cycle 1 (pre-dose, mid-infusion (30 minutes), end of infusion (EOI), and 1, 2, 12, 24, and 48 hours (hr) post-EOI); and Cycle 6 Day 1. |
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| Secondary | Mean Change From Baseline γ- H2A Histone Family Member X (H2AX) Intensity in Plucked Hair Follicles | Mean of each participant's value of baseline γH2AX intensity in plucked hair follicles after receiving the drug. The mean change of each participant would be calculated from available hair follicles (or eyebrows if scalp hairs are unobtainable) that contain a full intact follicle and sheath were collected (i.e., plucked) from participants scalp with forceps. Hair follicles were fluorescently stained for γ- H2A histone family member X (H2AX) analysis. | 15/45 participants were analyzed because we could not obtain enough intact follicle and sheaths from 30 participants for analysis. | Posted | Mean | Standard Deviation | Arbitrary units (AU) | 4 days | Plucked hair follicles | Plucked hair follicles |
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| Secondary | Pharmacodynamic (PD) Activity of EP0057 in Tumor Biopsy Specimens | Drug concentrations in tumor specimens. | Data was collected for 4 participants but not analyzed. We will never submit results because PD evaluation cannot be performed on baseline biopsies. Pharmacodynamic studies aim to assess the biological effects of a drug on its target or pathway within the tissue after administration. Baseline biopsies, collected prior to any treatment, reflect the untreated state of the tissue and therefore do not provide information on drug-induced changes or target modulation. | Posted | Ng/mL | Baseline, Cycle 1, then every 2 cycles, and at progression |
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| Other Pre-specified | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. | Posted | Count of Participants | Participants | Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months. |
|
All-Cause Mortality was monitored/assessed an average of 9.57 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 6.08 months.
Adverse Events will be recorded from the first study intervention, Study Day 1, through 30 days after the last study drug administration. Adverse events that are serious need to be recorded through 30 days after the last study drug administration. Beyond 30 days after the last study drug administration and through the end of study participation, only adverse events which are serious and related to the study intervention need to be recorded.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Solid Tumor Dose Level 1: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 100mg (by Mouth) | "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 100mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." | 3 | 3 | 2 | 3 | 3 | 3 |
| EG001 | Solid Tumor Dose Level 2: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 150mg (by Mouth) | "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 150mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." | 5 | 5 | 3 | 5 | 5 | 5 |
| EG002 | Solid Tumor Dose Level 3: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 200mg (by Mouth) | "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 200mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." | 3 | 3 | 1 | 3 | 3 | 3 |
| EG003 | Solid Tumor Dose Level 4: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 300mg (by Mouth) | "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 300mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." | 6 | 6 | 6 | 6 | 6 | 6 |
| EG004 | Solid Tumor Dose Level 4R: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 250mg (by Mouth) | "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." | 7 | 7 | 6 | 7 | 7 | 7 |
| EG005 | Small Cell Lung Cancer Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) | "Small cell lung cancer (SCLC) patients with resistant or sensitive relapse; EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." | 11 | 13 | 6 | 13 | 13 | 13 |
| EG006 | Urothelial Carcinoma Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) | "Confirmed diagnosis of urothelial. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." | 4 | 4 | 3 | 4 | 4 | 4 |
| EG007 | Metastatic Castration-Resistant Prostate Cancer Dose Level 4R: EP0057 12mg/m^2; Olaparib 250mg | "Confirmed diagnosis of metastatic, progressive, castrate resistant prostate cancer (mCRPC). Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." | 4 | 4 | 1 | 4 | 4 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Cystitis noninfective | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Death NOS | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hepatic infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Hepatobiliary disorders - Other, specify: Biliary obstruction | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infections and infestations - Other, specify: C diff | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Mobitz (type) II atrioventricular block | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment | - Other, specify: Malignant pleural mesothelioma |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment | - Other, specify: Newly detected right frontal parietal brain mass |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment | - Other, specify: Progressive Disease |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment | - Other, specify: Progressive disease |
|
| Nervous system disorders - Other, specify: Left lower extremity numbness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nervous system disorders - Other, specify: Word finding difficulty | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, specify: Redness of mediport area | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Stroke | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Alkalosis | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bloating | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Buttock pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| CPK increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Chest pain - cardiac | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chills | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Cystitis noninfective | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry eye | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema face | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Flushing | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| GGT increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastrointestinal disorders - Other, specify: Black stool | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| General disorders and administration site conditions - Other, specify: Disease progression | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| General disorders and administration site conditions - Other, specify: Night sweats | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hallucinations | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hepatobiliary disorders | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment | - Other, specify: Intrahepatic and extrahepatic biliary ductal dilation secondary to external compression |
|
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infections and infestations - Other, specify: C diff | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infections and infestations - Other, specify: oral candidiasis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infusion related reaction | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Laryngeal hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lipase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Localized edema | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Lymph node pain | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Mobitz (type) II atrioventricular block | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mucosal infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Musculoskeletal and connective tissue disorder - Other, specify: Cramping in L hand | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nail discoloration | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nervous system disorders - Other, specify: Muscle jerks | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Optic nerve disorder | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Papulopustular rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Periorbital edema | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Renal and urinary disorders - Other, specify: Urine output decreased | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rhinitis infective | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment | - Other, specify: Around the ankles- redness with no pain or itching. Possibly r/t walking in thick grass |
|
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment | - Other, specify: Lump on chest Left lower back(hip) and right ankle |
|
| Skin and subcutaneous tissue disorders - Other, specify: Rash: b/l LLE- no itching, not painful. | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, specify: Rash: rt shoulder, dry skin. | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, specify: Redness | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Stomach pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary urgency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vaginal hemorrhage | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Vaginal pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Voice alteration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Weight gain | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anish Thomas | National Cancer Institute | 240-760-7343 | anish.thomas@nih.gov |
| May 13, 2026 |
| Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 15, 2024 | Apr 10, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D002295 | Carcinoma, Transitional Cell |
| D008175 | Lung Neoplasms |
| D055752 | Small Cell Lung Carcinoma |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C542292 | IT-101 |
| C531550 | olaparib |
| D014057 | Tomography, X-Ray Computed |
| D004562 | Electrocardiography |
| D004452 | Echocardiography |
| D059552 | Caves |
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D014054 | Tomography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D004568 | Electrodiagnosis |
| D057791 | Cardiac Imaging Techniques |
| D014463 | Ultrasonography |
| D055593 | Geological Phenomena |
| D055585 | Physical Phenomena |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D004778 | Environment and Public Health |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| OG001 | Solid Tumor Dose Level 2: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 150mg (by Mouth) | "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 150mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG002 | Solid Tumor Dose Level 3: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 200mg (by Mouth) | "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 200mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG003 | Solid Tumor Dose Level 4: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 300mg (by Mouth) | "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 300mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG004 | Solid Tumor Dose Level 4R: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 250mg (by Mouth) | "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
|
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|
"Confirmed diagnosis of urothelial. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG002 | Metastatic Castration-Resistant Prostate Cancer Dose Level 4R: EP0057 12mg/m^2; Olaparib 250mg | "Confirmed diagnosis of metastatic, progressive, castrate resistant prostate cancer (mCRPC). Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
|
|
"Confirmed diagnosis of urothelial. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG002 | Metastatic Castration-Resistant Prostate Cancer Dose Level 4R: EP0057 12mg/m^2; Olaparib 250mg | "Confirmed diagnosis of metastatic, progressive, castrate resistant prostate cancer (mCRPC). Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
|
|
| OG001 | Solid Tumor Dose Level 2: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 150mg (by Mouth) | "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 150mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG002 | Solid Tumor Dose Level 3: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 200mg (by Mouth) | "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 200mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG003 | Solid Tumor Dose Level 4: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 300mg (by Mouth) | "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 300mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG004 | Solid Tumor Dose Level 4R: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 250mg (by Mouth) | "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
|
|
| OG002 | Solid Tumor Dose Level 3: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 200mg (by Mouth) | "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 200mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG003 | Solid Tumor Dose Level 4: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 300mg (by Mouth) | "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 300mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG004 | Solid Tumor Dose Level 4R: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 250mg (by Mouth) | "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG005 | Small Cell Lung Cancer Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) | "Small cell lung cancer (SCLC) patients with resistant or sensitive relapse; EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG006 | Urothelial Carcinoma Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) | "Confirmed diagnosis of urothelial. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG007 | Metastatic Castration-Resistant Prostate Cancer Dose Level 4R: EP0057 12mg/m^2; Olaparib 250mg | "Confirmed diagnosis of metastatic, progressive, castrate resistant prostate cancer (mCRPC). Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
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| OG001 | Solid Tumor Dose Level 2: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 150mg (by Mouth) | "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 150mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG002 | Solid Tumor Dose Level 3: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 200mg (by Mouth) | "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 200mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG003 | Solid Tumor Dose Level 4: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 300mg (by Mouth) | "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 300mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG004 | Solid Tumor Dose Level 4R: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 250mg (by Mouth) | "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG005 | Small Cell Lung Cancer Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) | "Small cell lung cancer (SCLC) patients with resistant or sensitive relapse; EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG006 | Urothelial Carcinoma Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) | "Confirmed diagnosis of urothelial. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG007 | Metastatic Castration-Resistant Prostate Cancer Dose Level 4R: EP0057 12mg/m^2; Olaparib 250mg | "Confirmed diagnosis of metastatic, progressive, castrate resistant prostate cancer (mCRPC). Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
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| OG001 | Solid Tumor Dose Level 2: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 150mg (by Mouth) | "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 150mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG002 | Solid Tumor Dose Level 3: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 200mg (by Mouth) | "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 200mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG003 | Solid Tumor Dose Level 4: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 300mg (by Mouth) | "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 300mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG004 | Solid Tumor Dose Level 4R: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 250mg (by Mouth) | "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
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| OG001 | Solid Tumor Dose Level 2: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 150mg (by Mouth) | "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 150mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG002 | Solid Tumor Dose Level 3: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 200mg (by Mouth) | "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 200mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG003 | Solid Tumor Dose Level 4: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 300mg (by Mouth) | "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 300mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG004 | Solid Tumor Dose Level 4R: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 250mg (by Mouth) | "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
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| OG001 | Solid Tumor Dose Level 2: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 150mg (by Mouth) | "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 150mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG002 | Solid Tumor Dose Level 3: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 200mg (by Mouth) | "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 200mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG003 | Solid Tumor Dose Level 4: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 300mg (by Mouth) | "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 300mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG004 | Solid Tumor Dose Level 4R: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 250mg (by Mouth) | "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG005 | Small Cell Lung Cancer Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) | "Small cell lung cancer (SCLC) patients with resistant or sensitive relapse; EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG006 | Urothelial Carcinoma Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) | "Confirmed diagnosis of urothelial. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG007 | Metastatic Castration-Resistant Prostate Cancer Dose Level 4R: EP0057 12mg/m^2; Olaparib 250mg | "Confirmed diagnosis of metastatic, progressive, castrate resistant prostate cancer (mCRPC). Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
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| Solid Tumor Dose Level 2: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 150mg (by Mouth) |
"Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 150mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG002 | Solid Tumor Dose Level 3: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 200mg (by Mouth) | "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 200mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG003 | Solid Tumor Dose Level 4: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 300mg (by Mouth) | "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 300mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG004 | Solid Tumor Dose Level 4R: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 250mg (by Mouth) | "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG005 | Small Cell Lung Cancer Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) | "Small cell lung cancer (SCLC) patients with resistant or sensitive relapse; EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG006 | Urothelial Carcinoma Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) | "Confirmed diagnosis of urothelial. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG007 | Metastatic Castration-Resistant Prostate Cancer Dose Level 4R: EP0057 12mg/m^2; Olaparib 250mg | "Confirmed diagnosis of metastatic, progressive, castrate resistant prostate cancer (mCRPC). Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
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| OG001 | Solid Tumor Dose Level 2: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 150mg (by Mouth) | "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 150mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG002 | Solid Tumor Dose Level 3: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 200mg (by Mouth) | "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 200mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG003 | Solid Tumor Dose Level 4: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 300mg (by Mouth) | "Confirmed solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 300mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG004 | Solid Tumor Dose Level 4R: EP0057 (CLRX101) 12mg/m^2 (Intravenous); Olaparib 250mg (by Mouth) | "Confirmed Solid tumor that is resistant or refractory to standard therapy. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG005 | Small Cell Lung Cancer Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) | "Small cell lung cancer (SCLC) patients with resistant or sensitive relapse; EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG006 | Urothelial Carcinoma Dose Level 4R:EP0057(CLRX101) 12mg/m^2(Intravenous); Olaparib 250mg(by Mouth) | "Confirmed diagnosis of urothelial. Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
| OG007 | Metastatic Castration-Resistant Prostate Cancer Dose Level 4R: EP0057 12mg/m^2; Olaparib 250mg | "Confirmed diagnosis of metastatic, progressive, castrate resistant prostate cancer (mCRPC). Drug: EP0057 12mg/m^2 will be administered as an intravenous (IV) infusion over 60-75 minutes every 2 weeks on Day 1 and Day 15 of each cycle. Other Names: • CLRX101 Pre-medication drugs include a corticosteroid (dexamethasone 20 mg IV) 30-120 minutes prior to start of EP0057, an antihistamine (diphenhydramine 50 mg by mouth (PO), an H2 antagonist H2 antagonist (histamine H2-receptor antagonists) (ranitidine 50 mg IV) Drug: Olaparib Phase I: A standard 3+3 design will be used, to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with Olaparib. Phase II: Maximum tolerated dose (MTD) identified in phase I. Olaparib 250mg will be given orally twice a day on days 3-13 and days 17-26 administered in 28-day cycles." |
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