Status:
TERMINATED
Momelotinib Combined With Capecitabine and Oxaliplatin in Adults With Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma
Lead Sponsor:
Sierra Oncology LLC - a GSK company
Conditions:
Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 metast...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
- Key
Exclusion
- Received more than 1 prior line of chemotherapy for metastatic pancreatic ductal adenocarcinoma
- 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
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
November 5 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2017
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT02244489
Start Date
November 5 2014
End Date
April 5 2017
Last Update
February 1 2019
Active Locations (4)
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1
Scottsdale Healthcare Research Institute
Scottsdale, Arizona, United States, 85258
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
Tennessee Oncology
Nashville, Tennessee, United States, 37203
4
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031