Momelotinib Combined With Capecitabine and Oxaliplatin in Adults With Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma

• Status: Terminated
• Trial end date: 2017-04-05
• Target enrollment: 0
• Participant gender: All

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 metastatic pancreatic ductal adenocarcinoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences; Sierra Oncology, Inc.
• Treatments: Capecitabine; N-(cyanomethyl)-4-(2-((4-(4-morpholinyl)phenyl)amino)-4-pyrimidinyl)benzamide; Oxaliplatin

Criteria

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

• 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 Criteria:

• 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.