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

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Sierra Oncology LLC - a GSK company

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Gilead Study Director

Principal Investigator

Gilead Sciences

Eligibility Criteria

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

See 5 more

Treatment Details

Interventions

Capecitabine (Anti-metabolite)
Momelotinib (JAK Inhibitor)
Oxaliplatin (Alkylating Agent)

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Momelotinib (MMB)+capecitabine+oxaliplatinExperimental Treatment3 Interventions

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.

Group II: Momelotinib (MMB)+capecitabineExperimental Treatment2 Interventions

Participants will receive momelotinib (MMB)+capecitabine at varying dose levels to determine the MTD for momelotinib (MMB) and capecitabine.

Capecitabine is already approved in Canada, Japan for the following indications: