Momelotinib Combined With Capecitabine and Oxaliplatin in Adults With Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma
NCT ID: NCT02244489
Last Updated: 2019-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
16 participants
INTERVENTIONAL
2014-11-05
2017-04-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Momelotinib (MMB)+capecitabine
Participants will receive momelotinib (MMB)+capecitabine at varying dose levels to determine the MTD for momelotinib (MMB) and capecitabine.
Momelotinib (MMB)
Momelotinib (MMB) tablet(s) administered orally once or twice daily
Capecitabine
Capecitabine tablet(s) administered orally twice daily for 14 days, followed by 7 days off, until the end of treatment
Momelotinib (MMB)+capecitabine+oxaliplatin
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.
Momelotinib (MMB)
Momelotinib (MMB) tablet(s) administered orally once or twice daily
Capecitabine
Capecitabine tablet(s) administered orally twice daily for 14 days, followed by 7 days off, until the end of treatment
Oxaliplatin
Oxaliplatin administered intravenously over 120 minutes or as per institutional standard of care on Day 1 of each 21-day cycle.
Interventions
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Momelotinib (MMB)
Momelotinib (MMB) tablet(s) administered orally once or twice daily
Capecitabine
Capecitabine tablet(s) administered orally twice daily for 14 days, followed by 7 days off, until the end of treatment
Oxaliplatin
Oxaliplatin administered intravenously over 120 minutes or as per institutional standard of care on Day 1 of each 21-day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x upper limit of normal (ULN) OR ≤ 5 x ULN if liver metastases are present; total conjugated bilirubin ≤ 2 x ULN
* Absolute neutrophil count (ANC) ≥1500 cells/mm\^3, platelet ≥100,000 cells/mm\^3, hemoglobin ≥ 9.0 g/dL
* Creatinine clearance (CrCl) \> 50 ml/min as calculated by the Cockroft-Gault method
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Exclusion Criteria
* Major surgery within 21 days of first dose of study drug
* Minor surgical procedure(s) within 7 days of enrollment or not yet recovered from prior minor surgery (placement of central venous access device, fine needle aspiration, or endoscopic biliary stent ≥ 1 day before enrollment is acceptable)
* Chemotherapy, immunotherapy, biologics, and/or investigational therapy within 21 days prior to first dose of study drug
* Known positive status for HIV, chronic active or acute viral hepatitis A, B, or C infection, or hepatitis B or C carrier
* Known dihydropyrimidine dehydrogenase deficiency
* Peripheral neuropathy ≥ Grade 2
* Any condition that impairs gastrointestinal absorption of drug
* Known or suspected brain or central nervous system metastases
* Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non-adenocarcinoma, adenocarcinoma originating from the biliary tree or cystadenocarcinoma
* External biliary drain
* Documented myocardial infarction or unstable/uncontrolled cardiac disease within 6 months of enrollment
18 Years
ALL
No
Sponsors
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Sierra Oncology LLC - a GSK company
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Scottsdale Healthcare Research Institute
Scottsdale, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Tennessee Oncology
Nashville, Tennessee, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Countries
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Other Identifiers
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GS-US-370-1369
Identifier Type: -
Identifier Source: org_study_id
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