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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-05958 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 10402 | Other Identifier | Yale University Cancer Center LAO | |
| 10402 | Other Identifier | CTEP | |
| UM1CA186689 | U.S. NIH Grant/Contract | View source |
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This phase I trial tests the safety, side effects and best dose of BAY 1895344 when given together with usual chemotherapy (irinotecan or topotecan) in treating patients with solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced), with a specific focus on small cell lung cancer, poorly differentiated neuroendocrine cancer, and pancreatic cancer. BAY 1895344 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as irinotecan and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding BAY 1895344 to irinotecan or topotecan may be safe and tolerable in treating patients with advanced solid tumors.
PRIMARY OBJECTIVES:
I. To assess safety and tolerability of each of the elimusertib (BAY 1895344) plus topoisomerase 1 (top1) inhibitor (irinotecan hydrochloride [irinotecan] or topotecan hydrochloride [topotecan]) combinations.
II. To estimate maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of each of the combinations.
SECONDARY OBJECTIVES:
I. To observe and record anti-tumor activity. II. To estimate objective response rate (ORR), progression free survival (PFS), overall survival (OS) and duration of response (DOR) in patients treated with each combination.
III. To estimate plasma pharmacokinetic (PK) characteristics of BAY 1895344 plus each top1 inhibitor (irinotecan or topotecan) when used in combination.
IV. To estimate changes in pharmacodynamic (PD) markers of deoxyribonucleic acid (DNA) damage (gamma-H2AX, phosphorylated [p]S343-NBS1) elicited by each combination from on-treatment tumor biopsies (in dose expansion cohorts only).
EXPLORATORY OBJECTIVES:
I. To estimate response outcomes (ORR, PFS, OS, DOR) in study patients by tumor ataxia telangiectasia mutated (ATM) expression loss (assessed by immunohistochemistry [IHC]).
II. To estimate response outcomes (ORR, PFS, OS, DOR) in study patients with tumor DNA damage response (DDR) mutations (assessed by whole exome sequencing [WES], ribonucleic acid [RNA] sequencing [RNA Seq], and circulating tumor DNA [ctDNA] analysis).
OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 3 cohorts.
COHORT I: Patients receive elimusertib orally (PO) twice daily (BID) on days 1 and 2 and irinotecan intravenously (IV) over 90 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening.
COHORT II: Patients receive elimusertib PO once daily (QD) on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening.
COHORT III: Patients receive elimusertib PO QD on days 2 and 5 and topotecan IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening.
After completion of study treatment, patients are followed every 2 months for up to 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort I (elimusertib, irinotecan) | Experimental | Patients receive elimusertib PO BID on days 1 and 2 and irinotecan IV over 90 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. |
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| Cohort II (elimusertib, irinotecan) | Experimental | Patients receive elimusertib PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. |
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| Cohort III (elimusertib, topotecan) | Experimental | Patients receive elimusertib PO QD on days 2 and 5 and topotecan IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biopsy Procedure | Procedure | Undergo tumor biopsy |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) (Dose Escalation Phase) of Elimursertib | Defined by occurrence of >= 2 dose limiting toxicities (DLTs) defined as grade 4 neutropenia lasting >= 7 days, grade 4 thrombocytopenia, grade 4 anemia, grade 3 neutropenia with fever, grade 3 thrombocytopenia with bleeding, any grade 3 hematologic toxicity lasting >= 7 days (counting from first day of toxicity grade recognition) or any non-hematologic grade >= 2 adverse events (AEs) lasting >= 7 days (with the exception of grade 2 [G2] fatigue, G2 nausea or G2 diarrhea) (counting from first day of toxicity grade recognition) in any dose level during cycle 1 of treatment. DLTs will be graded by Common Terminology Criteria for Adverse Events version 5.0. | Up to 21 days (first treatment cycle) |
| Maximum Tolerated Dose (MTD) (Dose Escalation Phase) of Irinotecan | Defined by occurrence of >= 2 dose limiting toxicities (DLTs) defined as grade 4 neutropenia lasting >= 7 days, grade 4 thrombocytopenia, grade 4 anemia, grade 3 neutropenia with fever, grade 3 thrombocytopenia with bleeding, any grade 3 hematologic toxicity lasting >= 7 days (counting from first day of toxicity grade recognition) or any non-hematologic grade >= 2 adverse events (AEs) lasting >= 7 days (with the exception of grade 2 [G2] fatigue, G2 nausea or G2 diarrhea) (counting from first day of toxicity grade recognition) in any dose level during cycle 1 of treatment. DLTs will be graded by Common Terminology Criteria for Adverse Events version 5.0. | Up to 21 days (first treatment cycle) |
| Maximum Tolerated Dose (MTD) (Dose Escalation Phase) of Topotecan | Defined by occurrence of >= 2 dose limiting toxicities (DLTs) defined as grade 4 neutropenia lasting >= 7 days, grade 4 thrombocytopenia, grade 4 anemia, grade 3 neutropenia with fever, grade 3 thrombocytopenia with bleeding, any grade 3 hematologic toxicity lasting >= 7 days (counting from first day of toxicity grade recognition) or any non-hematologic grade >= 2 adverse events (AEs) lasting >= 7 days (with the exception of grade 2 [G2] fatigue, G2 nausea or G2 diarrhea) (counting from first day of toxicity grade recognition) in any dose level during cycle 1 of treatment. DLTs will be graded by Common Terminology Criteria for Adverse Events version 5.0. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT and/or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = CR + PR. | Tumor response was performed every 6 weeks during treatment and up to 6 months after completing treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor ATM Expression Loss | Will assess the prevalence of tumor ATM expression loss in all patients. Will also estimate response outcomes (ORR, PFS, OS, DOR) in study patients by tumor ATM expression loss. | Baseline |
| Tumor Deoxyribonucleic Acid Damage Response (DDR) Gene Mutations Present |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thatcher Heumann | Yale University Cancer Center LAO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Hospital in Arizona | Phoenix | Arizona | 85054 | United States | ||
| UC Irvine Health/Chao Family Comprehensive Cancer Center |
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
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| ID | Title | Description |
|---|---|---|
| FG000 | TAC 1 (Elimusertib, Irinotecan) | Patients receive elimusertib 10 mg PO BID on days 1 and 2 and irinotecan 150 mg IV over 90 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI |
| 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 | Jul 31, 2024 |
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| Biospecimen Collection | Procedure | Undergo collection of blood samples |
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| Computed Tomography | Procedure | Undergo CT |
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| Elimusertib | Drug | Given PO |
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| Irinotecan Hydrochloride | Drug | Given IV |
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| Magnetic Resonance Imaging | Procedure | Undergo MRI |
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| Topotecan Hydrochloride | Drug | Given IV |
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| Up to 21 days (first treatment cycle) |
| Occurrence of Grade 4 Hematologic AEs (Dose Expansion Phase) | Grade 4 hematologic toxicity will be monitored using the Bayesian approach of Thall, Simon, Estey as extended by Thall and Sung. Clinical safety data (e.g. AEs) will be tabulated and summarized using descriptive statistics as requested by the sponsor investigator, executive committee, medical monitor or Data Safety Monitoring Board using methods described in the Data Safety Monitoring Plan. | Up to 6 months post-treatment |
| Duration of Response (DOR) | DOR will be estimated by the Kaplan-Meier method. Duration of response was calculated among patients with complete response, partial response, or stable disease. | Response was assessed every 6 weeks while the patient was on treatment, and up to 6 months post-treatment. |
| Progression-free Survival (PFS) | PFS will be estimated by the Kaplan-Meier method. | Disease Progression was assessed every 6 weeks while the patient was on treatment, and up to 6 months post-treatment. |
| Overall Survival (OS) | OS will be estimated by the Kaplan-Meier method. | From date the participant starts treatment until the date of death from any cause, assessed up to 6 months following completion of treatment |
| Maximum Concentration (Cmax) of Elimusertib | Estimated for elimusertib based upon plasma collections from cycle 1 in all study patients. TACs 1,2: Before treatment, 30 min, 1h, 1.3h, 2h, 4h, 6h, 8h, 24h, and 48 h after first elimusertib dose; TACs 4,5: on Cycle 1 Day 1 Before treatment, 30 min, 1h, and 1.3h into infusion and 0.5h, 2.5h, 4.5h and 22h post end of infusion and Day 2 30 min, 1h, 1.3, 2h, 4h, 6h, 8h, 24h after the first elimursertib dose; TACs 7,14: cycle 1 day 1 and 2 before infusion, 5, 15, and 25 min into infusion, and 5, 15, 30 min, 1, 2, 4, 6, and 24 h post end of infusion | See above as time frames were different fore each dose cohort |
| Area Under the Concentration-time Curve (AUC) for Elimusertib | Will be estimated for elimusertib based upon plasma collections from cycle 1 in all study patients. TACs 1,2: Before treatment, 30 min, 1h, 1.3h, 2h, 4h, 6h, 8h, 24h, and 48 h after first elimusertib dose; TACs 4,5: on Cycle 1 Day 1 Before treatment, 30 min, 1h, and 1.3h into infusion and 0.5h, 2.5h, 4.5h and 22h post end of infusion and Day 2 30 min, 1h, 1.3, 2h, 4h, 6h, 8h, 24h after the first elimursertib dose; TACs 7,14: cycle 1 day 1 and 2 before infusion, 5, 15, and 25 min into infusion, and 5, 15, 30 min, 1, 2, 4, 6, and 24 h post end of infusion | See above as time frames are different for each dose cohort |
| Maximum Concentration (Cmax) of Irinotecan (Cohorts I and II) | Estimated for irinotecan based upon plasma collections from cycle 1 in all study patients. TACs 1,2: Before treatment, 30 min, 1h, 1.3h, 2h, 4h, 6h, 8h, 24h, and 48 h after first elimusertib dose; TACs 4,5: on Cycle 1 Day 1 Before treatment, 30 min, 1h, and 1.3h into infusion and 0.5h, 2.5h, 4.5h and 22h post end of infusion and Day 2 30 min, 1h, 1.3, 2h, 4h, 6h, 8h, 24h after the first elimursertib dose | See above as time frames were different for each cohort |
| Area Under the Concentration-time Curve (AUC) for Irinotecan | Will be estimated for irinotecan based upon plasma collections from cycle 1 in all study patients. TACs 1,2: Before treatment, 30 min, 1h, 1.3h, 2h, 4h, 6h, 8h, 24h, and 48 h after first elimusertib dose; TACs 4,5: on Cycle 1 Day 1 Before treatment, 30 min, 1h, and 1.3h into infusion and 0.5h, 2.5h, 4.5h and 22h post end of infusion and Day 2 30 min, 1h, 1.3, 2h, 4h, 6h, 8h, 24h after the first elimursertib dose | See above as time frames were different for each cohort |
| Maximum Concentration (Cmax) of Topotecan (Cohort III, TACs 7 and 14) | Estimated for topotecan based upon plasma collections from cycle 1 in all study patients. | Cycle 1 day 1 and 2 before infusion, 5, 15, and 25 min into infusion, and 5, 15, 30 min, 1, 2, 4, 6, and 24 h post end of infusion |
| Area Under the Concentration-time Curve (AUC) for Topotecan | Will be estimated for topotecan based upon plasma collections from cycle 1 in all study patients. | Cycle 1 |
| Changes in Tumor Expression Patterns of Gamma-H2AX | Will be estimated for expansion cohort only study patients. | Baseline up to cycle 1, day 6 |
| Changes in Tumor Expression Patterns of pS343-NBS1 | Will be estimated for expansion cohort only study patients. | Baseline up to cycle 1, day 6 |
Will assess the specific tumor DDR gene mutations present in study patients. Will also estimate response outcomes (ORR, PFS, OS, DOR) in study patients with tumors with DDR gene mutations. |
| Baseline |
| Orange |
| California |
| 92868 |
| United States |
| Yale University | New Haven | Connecticut | 06520 | United States |
| Smilow Cancer Hospital Care Center-Trumbull | Trumbull | Connecticut | 06611 | United States |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | United States |
| University of Kansas Clinical Research Center | Fairway | Kansas | 66205 | United States |
| University of Kansas Cancer Center | Kansas City | Kansas | 66160 | United States |
| University of Kansas Cancer Center-Overland Park | Overland Park | Kansas | 66210 | United States |
| University of Kansas Hospital-Indian Creek Campus | Overland Park | Kansas | 66211 | United States |
| University of Kansas Hospital-Westwood Cancer Center | Westwood | Kansas | 66205 | United States |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| Siteman Cancer Center at Saint Peters Hospital | City of Saint Peters | Missouri | 63376 | United States |
| Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri | 63141 | United States |
| University of Kansas Cancer Center - North | Kansas City | Missouri | 64154 | United States |
| University of Kansas Cancer Center - Lee's Summit | Lee's Summit | Missouri | 64064 | United States |
| University of Kansas Cancer Center at North Kansas City Hospital | North Kansas City | Missouri | 64116 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Siteman Cancer Center-South County | St Louis | Missouri | 63129 | United States |
| Siteman Cancer Center at Christian Hospital | St Louis | Missouri | 63136 | United States |
| Montefiore Medical Center-Einstein Campus | The Bronx | New York | 10461 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| University of Pittsburgh Cancer Institute (UPCI) | Pittsburgh | Pennsylvania | 15232 | United States |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| FG001 | TAC 2 (Elimusertib, Irinotecan) | Patients receive elimusertib 20 mg PO BID on days 1 and 2 and irinotecan 150 mg IV over 90 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI |
| FG002 | TAC 4 (Elimusertib, Irinotecan) | Patients receive elimusertib 20 mg PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan 25 mg IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI |
| FG003 | TAC 5 (Elimusertib, Irinotecan) | Patients receive elimusertib 20 mg PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan 50 mg IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI |
| FG004 | TAC 7 (Elimusertib, Topotecan) | Patients receive elimusertib 20 mg PO BID on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV |
| FG005 | TAC 14 (Elimusertib, Topotecan) | Patients receive elimusertib 20 mg PO QD on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | TAC1 | TAC1: BAY1895344 10mg D1,2 + Irinotecan 150mg/m2 D1 |
| BG001 | TAC2 | TAC2: BAY1895344 20mg D1,2 + Irinotecan 150mg/m2 D1 |
| BG002 | TAC4 | TAC4: BAY 1895344 20 mg QD D2,3,9,10,16,17+Irinotecan 25 mg/m2 D1,8,15 |
| BG003 | TAC5 | TAC5: BAY 1895344 20 mg QD D2,3,9,10,16,17+Irinotecan 50 mg/m2 D1,8,15 |
| BG004 | TAC7 | TAC7: BAY1895344 20mg D2,5 + Topotecan 1mg/m2 D1-5 |
| BG005 | TAC14 | TAC14: BAY 1895344 20 mg QD D2,5+Topotecan 1 mg/m2 D1-5 |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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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, Continuous | Median | Full Range | 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 | Maximum Tolerated Dose (MTD) (Dose Escalation Phase) of Elimursertib | Defined by occurrence of >= 2 dose limiting toxicities (DLTs) defined as grade 4 neutropenia lasting >= 7 days, grade 4 thrombocytopenia, grade 4 anemia, grade 3 neutropenia with fever, grade 3 thrombocytopenia with bleeding, any grade 3 hematologic toxicity lasting >= 7 days (counting from first day of toxicity grade recognition) or any non-hematologic grade >= 2 adverse events (AEs) lasting >= 7 days (with the exception of grade 2 [G2] fatigue, G2 nausea or G2 diarrhea) (counting from first day of toxicity grade recognition) in any dose level during cycle 1 of treatment. DLTs will be graded by Common Terminology Criteria for Adverse Events version 5.0. | Posted | Number | mg | Up to 21 days (first treatment cycle) |
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| Primary | Maximum Tolerated Dose (MTD) (Dose Escalation Phase) of Irinotecan | Defined by occurrence of >= 2 dose limiting toxicities (DLTs) defined as grade 4 neutropenia lasting >= 7 days, grade 4 thrombocytopenia, grade 4 anemia, grade 3 neutropenia with fever, grade 3 thrombocytopenia with bleeding, any grade 3 hematologic toxicity lasting >= 7 days (counting from first day of toxicity grade recognition) or any non-hematologic grade >= 2 adverse events (AEs) lasting >= 7 days (with the exception of grade 2 [G2] fatigue, G2 nausea or G2 diarrhea) (counting from first day of toxicity grade recognition) in any dose level during cycle 1 of treatment. DLTs will be graded by Common Terminology Criteria for Adverse Events version 5.0. | Posted | Number | mg/m^2 | Up to 21 days (first treatment cycle) |
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| Primary | Maximum Tolerated Dose (MTD) (Dose Escalation Phase) of Topotecan | Defined by occurrence of >= 2 dose limiting toxicities (DLTs) defined as grade 4 neutropenia lasting >= 7 days, grade 4 thrombocytopenia, grade 4 anemia, grade 3 neutropenia with fever, grade 3 thrombocytopenia with bleeding, any grade 3 hematologic toxicity lasting >= 7 days (counting from first day of toxicity grade recognition) or any non-hematologic grade >= 2 adverse events (AEs) lasting >= 7 days (with the exception of grade 2 [G2] fatigue, G2 nausea or G2 diarrhea) (counting from first day of toxicity grade recognition) in any dose level during cycle 1 of treatment. DLTs will be graded by Common Terminology Criteria for Adverse Events version 5.0. | Posted | Number | mg/m^2 | Up to 21 days (first treatment cycle) |
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| Primary | Occurrence of Grade 4 Hematologic AEs (Dose Expansion Phase) | Grade 4 hematologic toxicity will be monitored using the Bayesian approach of Thall, Simon, Estey as extended by Thall and Sung. Clinical safety data (e.g. AEs) will be tabulated and summarized using descriptive statistics as requested by the sponsor investigator, executive committee, medical monitor or Data Safety Monitoring Board using methods described in the Data Safety Monitoring Plan. | Study was terminated prior to enrolling patients into dose expansion. | Posted | Up to 6 months post-treatment |
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| Secondary | Objective Response Rate (ORR) | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT and/or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = CR + PR. | Posted | Count of Participants | Participants | Tumor response was performed every 6 weeks during treatment and up to 6 months after completing treatment |
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| Secondary | Duration of Response (DOR) | DOR will be estimated by the Kaplan-Meier method. Duration of response was calculated among patients with complete response, partial response, or stable disease. | 0 participants in cohort TAC 7 had a complete response, partial response, or stable disease. | Posted | Median | 95% Confidence Interval | months | Response was assessed every 6 weeks while the patient was on treatment, and up to 6 months post-treatment. |
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| Secondary | Progression-free Survival (PFS) | PFS will be estimated by the Kaplan-Meier method. | Posted | Median | 95% Confidence Interval | months | Disease Progression was assessed every 6 weeks while the patient was on treatment, and up to 6 months post-treatment. |
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| Secondary | Overall Survival (OS) | OS will be estimated by the Kaplan-Meier method. | Posted | Median | 95% Confidence Interval | months | From date the participant starts treatment until the date of death from any cause, assessed up to 6 months following completion of treatment |
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| Secondary | Maximum Concentration (Cmax) of Elimusertib | Estimated for elimusertib based upon plasma collections from cycle 1 in all study patients. TACs 1,2: Before treatment, 30 min, 1h, 1.3h, 2h, 4h, 6h, 8h, 24h, and 48 h after first elimusertib dose; TACs 4,5: on Cycle 1 Day 1 Before treatment, 30 min, 1h, and 1.3h into infusion and 0.5h, 2.5h, 4.5h and 22h post end of infusion and Day 2 30 min, 1h, 1.3, 2h, 4h, 6h, 8h, 24h after the first elimursertib dose; TACs 7,14: cycle 1 day 1 and 2 before infusion, 5, 15, and 25 min into infusion, and 5, 15, 30 min, 1, 2, 4, 6, and 24 h post end of infusion | Posted | Geometric Mean | Standard Deviation | micrograms per liter | See above as time frames were different fore each dose cohort |
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| Secondary | Area Under the Concentration-time Curve (AUC) for Elimusertib | Will be estimated for elimusertib based upon plasma collections from cycle 1 in all study patients. TACs 1,2: Before treatment, 30 min, 1h, 1.3h, 2h, 4h, 6h, 8h, 24h, and 48 h after first elimusertib dose; TACs 4,5: on Cycle 1 Day 1 Before treatment, 30 min, 1h, and 1.3h into infusion and 0.5h, 2.5h, 4.5h and 22h post end of infusion and Day 2 30 min, 1h, 1.3, 2h, 4h, 6h, 8h, 24h after the first elimursertib dose; TACs 7,14: cycle 1 day 1 and 2 before infusion, 5, 15, and 25 min into infusion, and 5, 15, 30 min, 1, 2, 4, 6, and 24 h post end of infusion | Posted | Geometric Mean | Standard Deviation | mg/L*h | See above as time frames are different for each dose cohort |
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| Secondary | Maximum Concentration (Cmax) of Irinotecan (Cohorts I and II) | Estimated for irinotecan based upon plasma collections from cycle 1 in all study patients. TACs 1,2: Before treatment, 30 min, 1h, 1.3h, 2h, 4h, 6h, 8h, 24h, and 48 h after first elimusertib dose; TACs 4,5: on Cycle 1 Day 1 Before treatment, 30 min, 1h, and 1.3h into infusion and 0.5h, 2.5h, 4.5h and 22h post end of infusion and Day 2 30 min, 1h, 1.3, 2h, 4h, 6h, 8h, 24h after the first elimursertib dose | Posted | Geometric Mean | Standard Deviation | micrograms per liter | See above as time frames were different for each cohort |
| ||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Concentration-time Curve (AUC) for Irinotecan | Will be estimated for irinotecan based upon plasma collections from cycle 1 in all study patients. TACs 1,2: Before treatment, 30 min, 1h, 1.3h, 2h, 4h, 6h, 8h, 24h, and 48 h after first elimusertib dose; TACs 4,5: on Cycle 1 Day 1 Before treatment, 30 min, 1h, and 1.3h into infusion and 0.5h, 2.5h, 4.5h and 22h post end of infusion and Day 2 30 min, 1h, 1.3, 2h, 4h, 6h, 8h, 24h after the first elimursertib dose | Posted | Geometric Mean | Standard Deviation | mg/L*h | See above as time frames were different for each cohort |
| ||||||||||||||||||||||||||||||||||
| Secondary | Maximum Concentration (Cmax) of Topotecan (Cohort III, TACs 7 and 14) | Estimated for topotecan based upon plasma collections from cycle 1 in all study patients. | Posted | Geometric Mean | Standard Deviation | micrograms per liter | Cycle 1 day 1 and 2 before infusion, 5, 15, and 25 min into infusion, and 5, 15, 30 min, 1, 2, 4, 6, and 24 h post end of infusion |
| ||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Concentration-time Curve (AUC) for Topotecan | Will be estimated for topotecan based upon plasma collections from cycle 1 in all study patients. | Posted | Geometric Mean | Standard Deviation | ug/L*h | Cycle 1 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Changes in Tumor Expression Patterns of Gamma-H2AX | Will be estimated for expansion cohort only study patients. | Study was terminated prior to enrolling patients into dose expansion. | Posted | Baseline up to cycle 1, day 6 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Changes in Tumor Expression Patterns of pS343-NBS1 | Will be estimated for expansion cohort only study patients. | Study was terminated prior to enrolling patients into dose expansion. | Posted | Baseline up to cycle 1, day 6 |
|
| |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Tumor ATM Expression Loss | Will assess the prevalence of tumor ATM expression loss in all patients. Will also estimate response outcomes (ORR, PFS, OS, DOR) in study patients by tumor ATM expression loss. | Not Posted | Baseline | Participants | |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Tumor Deoxyribonucleic Acid Damage Response (DDR) Gene Mutations Present | Will assess the specific tumor DDR gene mutations present in study patients. Will also estimate response outcomes (ORR, PFS, OS, DOR) in study patients with tumors with DDR gene mutations. | Not Posted | Baseline | Participants |
During treatment (up to 9 months) and through 6 months following completion of therapy, up to 15 months for each participant
All patients that received at least one dose of protocol prescribed treatment are included in this analysis.
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 | TAC1 (10 mg Elimusertib, Biweekly 150 mg/m^2 Irinotecan) | Patients receive elimusertib PO BID on days 1 and 2 and irinotecan IV over 90 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI | 5 | 6 | 1 | 6 | 6 | 6 |
| EG001 | TAC2 (20 mg Elimusertib, Biweekly 150 mg/m^2 Irinotecan) | Patients receive elimusertib PO BID on days 1 and 2 and irinotecan IV over 90 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI | 3 | 3 | 2 | 3 | 3 | 3 |
| EG002 | TAC4 (20 mg Elimusertib, Weekly 25 mg/m^2 Irinotecan) | Patients receive elimusertib PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI | 3 | 6 | 1 | 6 | 5 | 6 |
| EG003 | TAC5 (20 mg Elimusertib, 50 mg/m^2 Weekly Irinotecan) | Patients receive elimusertib PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI | 5 | 6 | 4 | 6 | 6 | 6 |
| EG004 | TAC7 (20 mg Elimusertib, 1 mg/m^2 Topotecan) | Patients receive elimusertib PO BID on days 2 and 5 and topotecan IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV | 2 | 2 | 2 | 2 | 2 | 2 |
| EG005 | TAC14 (20 mg Elimusertib, 1 mg/m^2 Topotecan) | Patients receive elimusertib PO QD on days 2 and 5 and topotecan IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV | 4 | 6 | 1 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial Infarction | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| White Blood Cell Count Decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Kidney Infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Death | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Gastric Outlet Obstruction | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Leukopenia | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Neutropenia | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Thrombocytopenia | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pancytopenia | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Cramping | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Alkaline Phosphatase increase | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Aspartate Aminotransferase | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| AST increase | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Biliary Obstruction | Hepatobiliary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Bilirubin increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Bloating | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Blurry Vision | Eye disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Body Aches | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Chest Pain | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Chills | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| COVID-19 | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| creatinine increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Decreased iron | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Decreased Lymphocyte Count | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
| |
| depression | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Diaphoresis | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Diarrhea (pt describes as loose stool) | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Diarrhea-Intermittent | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dizziness Intermittent | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| dry skin | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| early satiety | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Extrapyramidal disorder (restless leg syndrome) | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| fever | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Flushing (cheeks) | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hemorrhoid | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| HOT FLASHES | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| hyperglycemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| hypertension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| hypocalcemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| hypomagnesemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| hypophosphatemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| hypotension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Increased Alk Phos | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Increased ALT | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Increased AST | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Increased LDH | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Increased Total Bilirubin | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
| |
| INTERMITTENT VOMITING | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Jaw Mass | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Left Chest Pain (Non cardiac) | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Left groin boil | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Left Shoulder Skin Abscess | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| loss of appetite | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Low WBC | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Lymphocyte Count Decrease | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Malaise | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Mouth Sores | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Neutropenia | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Neutrophil Count Decrease | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Night sweats | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Non-cardiac chest pain' | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Oral mucositis | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pain - R inguinal pain | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pain (Left Arm) | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pain (right side pain) | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| pain in extremity (right shoulder pain) | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pain in Leg | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Platelet Count Decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Platelet Count Decrease (Thrombocytopenia) | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Pleuritic Pain | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| port site erythema | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| presyncope | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| pruitis (legs) | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| pruritis right middle back | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pyuria | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Rash Maculo-papular ash acneiform | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| right chest tenderness | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Sacral pressure wound | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Shoulder Pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| skin and subcutaneous tissue disorders other - right index finder laceration | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Tachypneic | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Thrush | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| troponin elevated | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Upper respiratory Infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Urinary Frequency | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Vitreous Hemorrhage | Eye disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Volume Overload | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Weight Loss | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| White Blood Cell Decrease (Intermittent) | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Worsening anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| worsening anorexia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Worsening Constipation | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Worsening Fatigue | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| worsening historic anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| worsening Hypertension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| worsening weight loss | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Worsening white blood cell decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thatcher Heumann, MD, MPH | Vanderbilt University Medical Center | 615-936-8422 | thatcher.heumann@vumc.org |
| Mar 3, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 31, 2023 | Feb 17, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| D009362 | Neoplasm Metastasis |
| D018278 | Carcinoma, Neuroendocrine |
| D008175 | Lung Neoplasms |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D004067 | Digestive System Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D013048 | Specimen Handling |
| C000711582 | BAY 1895344 |
| D000077146 | Irinotecan |
| D009682 | Magnetic Resonance Spectroscopy |
| D019772 | Topotecan |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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| Participants |
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| OG002 | TAC 4 (Elimusertib, Irinotecan) | Patients receive elimusertib 20 mg PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan 25 mg IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI |
| OG003 | TAC 5 (Elimusertib, Irinotecan) | Patients receive elimusertib 20 mg PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan 50 mg IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI |
| OG004 | TAC 7 (Elimusertib, Topotecan) | Patients receive elimusertib 20 mg PO BID on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV |
| OG005 | TAC 14 (Elimusertib, Topotecan) | Patients receive elimusertib 20 mg PO QD on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV |
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| OG002 | TAC 4 (Elimusertib, Irinotecan) | Patients receive elimusertib 20 mg PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan 25 mg IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI |
| OG003 | TAC 5 (Elimusertib, Irinotecan) | Patients receive elimusertib 20 mg PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan 50 mg IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI |
| OG004 | TAC 7 (Elimusertib, Topotecan) | Patients receive elimusertib 20 mg PO BID on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV |
| OG005 | TAC 14 (Elimusertib, Topotecan) | Patients receive elimusertib 20 mg PO QD on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV |
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| OG002 | TAC 4 (Elimusertib, Irinotecan) | Patients receive elimusertib 20 mg PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan 25 mg IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI |
| OG003 | TAC 5 (Elimusertib, Irinotecan) | Patients receive elimusertib 20 mg PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan 50 mg IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI |
| OG004 | TAC 7 (Elimusertib, Topotecan) | Patients receive elimusertib 20 mg PO BID on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV |
| OG005 | TAC 14 (Elimusertib, Topotecan) | Patients receive elimusertib 20 mg PO QD on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV |
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| OG002 | TAC 4 (Elimusertib, Irinotecan) | Patients receive elimusertib 20 mg PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan 25 mg IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI |
| OG003 | TAC 5 (Elimusertib, Irinotecan) | Patients receive elimusertib 20 mg PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan 50 mg IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI |
| OG004 | TAC 7 (Elimusertib, Topotecan) | Patients receive elimusertib 20 mg PO BID on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV |
| OG005 | TAC 14 (Elimusertib, Topotecan) | Patients receive elimusertib 20 mg PO QD on days 2 and 5 and topotecan 1 mg IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV |
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| OG002 | TAC4 (20 mg Elimusertib, Weekly 25 mg/m^2 Irinotecan) | Patients receive elimusertib PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI |
| OG003 | TAC5 (20 mg Elimusertib, 50 mg/m^2 Weekly Irinotecan) | Patients receive elimusertib PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI |
| OG004 | TAC7 (20 mg Elimusertib, 1 mg/m^2 Topotecan) | Patients receive elimusertib PO BID on days 2 and 5 and topotecan IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV |
| OG005 | TAC14 (20 mg Elimusertib, 1 mg/m^2 Topotecan) | Patients receive elimusertib PO QD on days 2 and 5 and topotecan IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV |
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| OG002 | TAC4 (20 mg Elimusertib, Weekly 25 mg/m^2 Irinotecan) | Patients receive elimusertib PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI |
| OG003 | TAC5 (20 mg Elimusertib, 50 mg/m^2 Weekly Irinotecan) | Patients receive elimusertib PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI |
| OG004 | TAC7 (20 mg Elimusertib, 1 mg/m^2 Topotecan) | Patients receive elimusertib PO BID on days 2 and 5 and topotecan IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV |
| OG005 | TAC14 (20 mg Elimusertib, 1 mg/m^2 Topotecan) | Patients receive elimusertib PO QD on days 2 and 5 and topotecan IV over 30 minutes on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Magnetic Resonance Imaging: Undergo MRI Topotecan Hydrochloride: Given IV |
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| OG002 | TAC4 (20 mg Elimusertib, Weekly 25 mg/m^2 Irinotecan) | Patients receive elimusertib PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI |
| OG003 | TAC5 (20 mg Elimusertib, 50 mg/m^2 Weekly Irinotecan) | Patients receive elimusertib PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI |
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| OG002 | TAC4 (20 mg Elimusertib, Weekly 25 mg/m^2 Irinotecan) | Patients receive elimusertib PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI |
| OG003 | TAC5 (20 mg Elimusertib, 50 mg/m^2 Weekly Irinotecan) | Patients receive elimusertib PO QD on days 2, 3, 9, 10, 16, and 17 of cycle 1 and 2, and on days 2, 3, 9, and 10 of each cycle thereafter. Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 of cycle 1 and 2, and on days 1 and 8 of each cycle thereafter. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT and/or MRI throughout the study, tumor biopsy at screening and on study, and collection of blood samples at screening. Biopsy: Undergo tumor biopsy Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Elimusertib: Given PO Irinotecan Hydrochloride: Given IV Magnetic Resonance Imaging: Undergo MRI |
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