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This study will evaluate the safety, tolerability, and define the maximum tolerated dose (MTD) of momelotinib (MMB) combined with capecitabine and oxaliplatin in adults with relapsed/refractory metastatic pancreatic ductal adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Momelotinib (MMB)+capecitabine | Experimental | Participants will receive momelotinib (MMB)+capecitabine at varying dose levels to determine the MTD for momelotinib (MMB) and capecitabine. |
|
| Momelotinib (MMB)+capecitabine+oxaliplatin | Experimental | Upon reaching the MTD for momelotinib (MMB) and capecitabine or if no MTD is reached, participants will receive momelotinib (MMB)+capecitabine at the MTD plus oxaliplatin at varying dose levels to determine the MTD of combination capecitabine, momelotinib (MMB), and oxaliplatin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Momelotinib (MMB) | Drug | Momelotinib (MMB) tablet(s) administered orally once or twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose limiting toxicities | Dose limiting toxicities refer to toxicities experienced during the first 21 days of treatment that have been judged to be clinically significant and at least possibly related to study treatment. | Up to 21 days |
| Incidence of adverse events, assessment of clinical laboratory test findings, physical examination, 12-lead electrocardiogram (ECG), and vital signs measurements | This composite endpoint will measure the safety profile of momelotinib. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | Overall response rate (ORR) is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) as assessed by the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. | Up to 2 years |
| Overall survival |
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Key Inclusion Criteria:
Relapsed or refractory metastatic pancreatic adenocarcinoma
Received 1 prior chemotherapy regimen for metastatic pancreatic ductal adenocarcinoma (not including neoadjuvant and/or adjuvant therapy)
Measurable disease per RECIST v1.1
Adequate organ function defined as
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale Healthcare Research Institute | Scottsdale | Arizona | 85258 | United States | ||
| Cedars-Sinai Medical Center |
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|
| Capecitabine | Drug | Capecitabine tablet(s) administered orally twice daily for 14 days, followed by 7 days off, until the end of treatment |
|
| Oxaliplatin | Drug | Oxaliplatin administered intravenously over 120 minutes or as per institutional standard of care on Day 1 of each 21-day cycle. |
|
Overall survival (OS) is defined as the interval from first dose date of study drug to death from any cause. |
| Up to 2 years |
| Progression-free survival | Progression-free survival (PFS) is defined as the interval from first dose date of study drug to the earlier of the first documentation of definitive disease progression or death from any cause; definitive disease progression is progression based on RECIST criteria v1.1. | Up to 2 years |
| Pharmacokinetic (PK) profile of momelotinib (MMB) | This composite endpoint will measure the plasma PK profile of momelotinib (MMB). The following parameters will be measured, where applicable:
| Predose and postdose on Day 15 |
| Los Angeles |
| California |
| 90048 |
| United States |
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | United States |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C546012 | N-(cyanomethyl)-4-(2-((4-(4-morpholinyl)phenyl)amino)-4-pyrimidinyl)benzamide |
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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