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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-01249 | Other Identifier | CTRP (Clinical Trial Reporting Program) |
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This partially randomized phase Ib/II trial studies the side effects and best dose of selinexor when given together with gemcitabine and nab-paclitaxel, and to see how well they work in treating patients with pancreatic cancer that has spread to other parts of the body (metastatic). Drugs used in chemotherapy, such as selinexor, gemcitabine and nab-paclitaxel, 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.
Primary Objectives:
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I: Phase Ib (gemcitabine, nab-paclitaxel, selinexor) | Experimental | Patients receive gemcitabine hydrochloride IV, nab-paclitaxel IV, and selinexor PO on days 1, 8, and 15. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. |
|
| Group II: Phase II Group I (gemcitabine, selinexor) | Experimental | Patients receive gemcitabine hydrochloride IV on days 1, 8, and 15. Patients also receive selinexor PO on days 3, 8, and 15 of cycle 1 and on days 1, 8, and 15 for the subsequent cycles. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity |
|
| GroupIII: Phase II Group II (gemcitabine, selinexor) | Experimental | Patients receive gemcitabine hydrochloride IV and selinexor PO on days 1, 8, and 15. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine hydrochloride | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of Selinexor, Gemcitabine Hydrochloride, and Paclitaxel Albumin-stabilized Nanoparticle Formulation Combination (Phase Ib) | MTD is defined as the lowest dose for which less than a third of patients experience a dose limiting toxicity graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. | 28 days |
| Proportion of Patients With a Toxic Event, Graded According to NCI CTCAE Version 4.03 | The reported output is the proportion of patients that had a toxic event along with the associated 90% Wilson's confidence interval. | Up to 2 years |
| Overall Survival (Phase II) | Estimated on an intention-to-treat basis (using all registered patients), and on a response-evaluable basis (using all patients who completed at least one 4-week treatment cycle) using the Kaplan-Meier method. | Up to 7 months post treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Effects the Study Drug Combination Has on Participants | Pharmacodynamics of selinexor in combination with gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation | Day 1 of course 1 (before selinexor administration, 1, 2, 4 and 8 hours after selinexor administration) and days 2, 3 and 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gene Expression (Including Forkhead Box Protein O, I-kappaB, Cyclin-dependent Kinase Inhibitor 1B, Par4 and Phosphorylated Signal Transducer and Activator of Transcription 3) (Phase II) | Seven patients in each group will yield a two-sided 90% confidence interval with a distance from the mean change to the limits of 0.75 standard deviation units. A two-sided p-value of 0.10 will be used for all analyses. |
Inclusion Criteria:
Exclusion Criteria:
Patients who are pregnant or lactating
Radiation, chemotherapy, or immunotherapy or any other anticancer therapy =< 3 weeks prior to cycle 1 day 1; mitomycin C or radio-immunotherapy 6 weeks prior to cycle 1 day 1
Major surgery within four weeks before cycle 1 day 1
Unstable cardiovascular function:
Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose
Known to be HIV seropositive who are on anti-HIV drugs because of the unknown interactions between these drugs and the study agents
Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C virus (HCV) ribonucleic acid (RNA) or HBsAg (hepatitis B virus [HBV] surface antigen)
Patients with active central nervous system (CNS) malignancy; asymptomatic small lesions are not considered active; treated lesions may be considered inactive if they are stable for at least 3 months
Patients with significantly diseased or obstructed gastrointestinal tract or uncontrolled vomiting or diarrhea
Grade >= 2 peripheral neuropathy within 14 days prior to cycle 1 day 1
History of seizures, movement disorders or cerebrovascular accident within the past 5 years prior to cycle 1 day 1
Patients with muscular degeneration, uncontrolled glaucoma, or markedly decreased visual acuity based on physician's assessment
Serious psychiatric or medical conditions that could interfere with treatment
Participation in an investigational anti-cancer study within 3 weeks prior to cycle 1 day 1
Concurrent therapy with approved or investigational anticancer therapeutic
Presence of clinically significant ascites
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| Name | Affiliation | Role |
|---|---|---|
| Mohammed N Al Hallak, M.D. | Barbara Ann Karmanos Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States | ||
| Stony Brook University Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31831564 | Derived | Azmi AS, Khan HY, Muqbil I, Aboukameel A, Neggers JE, Daelemans D, Mahipal A, Dyson G, Kamgar M, Al-Hallak MN, Tesfaye A, Kim S, Shidham V, M Mohammad R, Philip PA. Preclinical Assessment with Clinical Validation of Selinexor with Gemcitabine and Nab-Paclitaxel for the Treatment of Pancreatic Ductal Adenocarcinoma. Clin Cancer Res. 2020 Mar 15;26(6):1338-1348. doi: 10.1158/1078-0432.CCR-19-1728. Epub 2019 Dec 12. |
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2 patients enrolled but did not receive any treatment
Accrual time period: 10/31/14 - 02/09/22
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| ID | Title | Description |
|---|---|---|
| FG000 | Group I: Phase Ib (Gemcitabine, Nab-paclitaxel, Selinexor) | Patients receive gemcitabine hydrochloride IV, nab-paclitaxel IV, and selinexor PO on days 1, 8, and 15. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Nab paclitaxel: Given IV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| 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 18, 2022 |
Not provided
Phase I is completed, due to Dose Limiting Toxicities (DLT).
Not provided
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|
| Selinexor | Drug | Given IV |
|
|
| Pharmacological Study | Other | Correlative studies |
|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Nab paclitaxel | Drug | Given IV |
|
|
| Proportion of Patients With a Response |
Point and 90% Wilson's confidence intervals will be estimated to describe response rate. If the best observed clinical response was complete response or partial response, we consider that the patient responded. |
| Up to 2 years |
| Progression Free Survival (Phase II) | Estimated on an intention-to-treat basis (using all registered patients), and on a response-evaluable basis (using all patients who completed at least one 4-week treatment cycle) using the Kaplan-Meier method. Both progression and death are considered events for this analysis. | Up to 2 years |
| Baseline to up to 2 years |
| Stony Brook |
| New York |
| 11794 |
| United States |
| FG001 | Group II: Phase II Group I (Gemcitabine, Selinexor) | Patients receive gemcitabine hydrochloride IV on days 1, 8, and 15. Patients also receive selinexor PO on days 3, 8, and 15 of cycle 1 and on days 1, 8, and 15 for the subsequent cycles. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies |
| FG002 | GroupIII: Phase II Group II (Gemcitabine, Selinexor) | Patients receive gemcitabine hydrochloride IV and selinexor PO on days 1, 8, and 15. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies |
| COMPLETED |
|
| NOT COMPLETED |
|
Group II enrolled no patients because patients refused to undergo the required biopsy.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group I: Phase Ib (Gemcitabine, Nab-paclitaxel, Selinexor) | Patients receive gemcitabine hydrochloride IV, nab-paclitaxel IV, and selinexor PO on days 1, 8, and 15. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Nab paclitaxel: Given IV |
| BG001 | Group II: Phase II Group I (Gemcitabine, Selinexor) | Patients receive gemcitabine hydrochloride IV on days 1, 8, and 15. Patients also receive selinexor PO on days 3, 8, and 15 of cycle 1 and on days 1, 8, and 15 for the subsequent cycles. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies |
| BG002 | GroupIII: Phase II Group II (Gemcitabine, Selinexor) | Patients receive gemcitabine hydrochloride IV and selinexor PO on days 1, 8, and 15. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of Selinexor, Gemcitabine Hydrochloride, and Paclitaxel Albumin-stabilized Nanoparticle Formulation Combination (Phase Ib) | MTD is defined as the lowest dose for which less than a third of patients experience a dose limiting toxicity graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. | Maximum tolerated dose is only estimated using the Phase 1b samples | Posted | Number | milligrams | 28 days |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Proportion of Patients With a Toxic Event, Graded According to NCI CTCAE Version 4.03 | The reported output is the proportion of patients that had a toxic event along with the associated 90% Wilson's confidence interval. | Group II enrolled no patients because patients refused to undergo the required biopsy. | Posted | Number | 90% Confidence Interval | proportion of patients | Up to 2 years |
| |||||||||||||||||||||||||||||||||
| Primary | Overall Survival (Phase II) | Estimated on an intention-to-treat basis (using all registered patients), and on a response-evaluable basis (using all patients who completed at least one 4-week treatment cycle) using the Kaplan-Meier method. | Group II enrolled no patients because patients refused to undergo the required biopsy. | Posted | Median | 90% Confidence Interval | months | Up to 7 months post treatment initiation |
| |||||||||||||||||||||||||||||||||
| Secondary | Effects the Study Drug Combination Has on Participants | Pharmacodynamics of selinexor in combination with gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation | Pharmacodynamics data was not measured. | Posted | Day 1 of course 1 (before selinexor administration, 1, 2, 4 and 8 hours after selinexor administration) and days 2, 3 and 8 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients With a Response | Point and 90% Wilson's confidence intervals will be estimated to describe response rate. If the best observed clinical response was complete response or partial response, we consider that the patient responded. | Group II enrolled no patients because patients refused to undergo the required biopsy. Four patients in Group I were not evaluated for response. | Posted | Number | 90% Confidence Interval | proportion of patients | Up to 2 years |
| |||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (Phase II) | Estimated on an intention-to-treat basis (using all registered patients), and on a response-evaluable basis (using all patients who completed at least one 4-week treatment cycle) using the Kaplan-Meier method. Both progression and death are considered events for this analysis. | Group II enrolled no patients because patients refused to undergo the required biopsy. | Posted | Median | 90% Confidence Interval | months | Up to 2 years |
| |||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Gene Expression (Including Forkhead Box Protein O, I-kappaB, Cyclin-dependent Kinase Inhibitor 1B, Par4 and Phosphorylated Signal Transducer and Activator of Transcription 3) (Phase II) | Seven patients in each group will yield a two-sided 90% confidence interval with a distance from the mean change to the limits of 0.75 standard deviation units. A two-sided p-value of 0.10 will be used for all analyses. | Gene expression data was not measured. | Posted | Baseline to up to 2 years |
|
The adverse events were collected from cycle one day one of study treatment until four weeks follow up visit or thirty days after study treatment was discontinued up to 2 years.
No patients were enrolled in Group 2, so the number of patients at risk is 0 for that group.
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 | Group I: Phase Ib (Gemcitabine, Nab-paclitaxel, Selinexor) | Patients receive gemcitabine hydrochloride IV, nab-paclitaxel IV, and selinexor PO on days 1, 8, and 15. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Nab paclitaxel: Given IV | 9 | 9 | 6 | 9 | 9 | 9 |
| EG001 | Group II: Phase II Group I (Gemcitabine, Selinexor) | Patients receive gemcitabine hydrochloride IV on days 1, 8, and 15. Patients also receive selinexor PO on days 3, 8, and 15 of cycle 1 and on days 1, 8, and 15 for the subsequent cycles. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | GroupIII: Phase II Group II (Gemcitabine, Selinexor) | Patients receive gemcitabine hydrochloride IV and selinexor PO on days 1, 8, and 15. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies | 0 | 4 | 0 | 4 | 4 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Cognitive disturbance | Nervous system disorders | Systematic Assessment |
| ||
| Death NOS | General disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Hyperglycemia | Investigations | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Psychiatric disorders - Other | Psychiatric disorders | Systematic Assessment |
| ||
| Renal and urinary disorders - Other | Renal and urinary disorders | Systematic Assessment |
| ||
| Stroke | Nervous system disorders | Systematic Assessment |
| ||
| Suicidal ideation | Psychiatric disorders | Systematic Assessment |
| ||
| Suicide attempt | Psychiatric disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Alkaline phosphatase increased | Investigations | Systematic Assessment |
| ||
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anorexia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Ascites | Gastrointestinal disorders | Systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Blood bilirubin increased | Investigations | Systematic Assessment |
| ||
| Blurred vision | Eye disorders | Systematic Assessment |
| ||
| Bruising | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Chills | General disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Creatinine increased | Investigations | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dysgeusia | Nervous system disorders | Systematic Assessment |
| ||
| Ear and labyrinth disorders - Other, specify | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Ear pain | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Eye disorders - Other, specify | Eye disorders | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Flashing lights | Eye disorders | Systematic Assessment |
| ||
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | Systematic Assessment |
| ||
| General disorders and administration site conditions - Other, specify | General disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Hemorrhoids | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hot flashes | Vascular disorders | Systematic Assessment |
| ||
| Hyperglycemia | Investigations | Systematic Assessment |
| ||
| Hypoalbuminemia | Investigations | Systematic Assessment |
| ||
| Hypoglycemia | Investigations | Systematic Assessment |
| ||
| Hypokalemia | Investigations | Systematic Assessment |
| ||
| Infections and infestations - Other, specify | Infections and infestations | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Malaise | General disorders | Systematic Assessment |
| ||
| Mucositis oral | Gastrointestinal disorders | Systematic Assessment |
| ||
| Musculoskeletal and connective tissue disorder - Other, specify | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Neuralgia | Nervous system disorders | Systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Systematic Assessment |
| ||
| Peripheral sensory neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Platelet count decreased | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Psychiatric disorders - Other, specify | Psychiatric disorders | Systematic Assessment |
| ||
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin ulceration | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Upper respiratory infection | Infections and infestations | Systematic Assessment |
| ||
| Urinary frequency | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Weight loss | Investigations | Systematic Assessment |
| ||
| White blood cell decreased | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Edema limbs | General disorders | Systematic Assessment |
| ||
| Oral dysesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Gastroesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
| ||
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hyponatremia | Investigations | Systematic Assessment |
| ||
| Rectal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
Not provided
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Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mohammed Najeeb Al Hallak M.D. | Karmanos Cancer Institute | 313-576-8718 | alhallakm@karmanos.org |
| Mar 29, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| C585161 | selinexor |
| D013660 | Taxes |
| D000068196 | Albumin-Bound Paclitaxel |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| 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 |
|
| GroupIII: Phase II Group II (Gemcitabine, Selinexor) |
Patients receive gemcitabine hydrochloride IV and selinexor PO on days 1, 8, and 15. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies |
|
|
| OG002 |
| GroupIII: Phase II Group II (Gemcitabine, Selinexor) |
Patients receive gemcitabine hydrochloride IV and selinexor PO on days 1, 8, and 15. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies |
|
|
| GroupIII: Phase II Group II (Gemcitabine, Selinexor) |
Patients receive gemcitabine hydrochloride IV and selinexor PO on days 1, 8, and 15. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies |
|
| OG002 | GroupIII: Phase II Group II (Gemcitabine, Selinexor) | Patients receive gemcitabine hydrochloride IV and selinexor PO on days 1, 8, and 15. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies |
|
|
| OG002 | GroupIII: Phase II Group II (Gemcitabine, Selinexor) | Patients receive gemcitabine hydrochloride IV and selinexor PO on days 1, 8, and 15. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies |
|
|
| OG002 | GroupIII: Phase II Group II (Gemcitabine, Selinexor) | Patients receive gemcitabine hydrochloride IV and selinexor PO on days 1, 8, and 15. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies |
|