Date: 2014-03-28
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Gilead Sciences (USA - CA)
Product: momelotinib
Action
mechanism: tyrosine kinase. Momelotinib is an inhibitor of Janus kinases JAK1 and JAK2.
Disease: metastatic pancreatic ductal adenocarcinoma
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: This phase 3 randomized, double-blind, placebo-controlled study is evaluating gemcitabine and Nab-paclitaxel combined with momelotinib in subjects with previously untreated metastatic pancreatic ductal adenocarcinoma.
There will be two phases to this study. The lead-in phase will evaluate the safety, pharmacokinetics, and define the maximum tolerated dose (MTD) of momelotinib combined with nab-paclitaxel and gemcitabine in adults with previously untreated metastatic pancreatic ductal adenocarcinoma. The randomized treatment phase will evaluate the efficacy, safety, and tolerability of nab-paclitaxel and gemcitabine combined with either momelotinib administered at the MTD or placebo in adults with previously untreated metastatic pancreatic ductal adenocarcinoma as measured by improvement in overall survival (OS), progression free survival (PFS), and overall response rate (ORR). Participants will continue study treatment until disease progression, unacceptable toxicity, consent withdrawal, or participant's refusal of treatment. Following treatment, participants will be followed for safety for 30 days and for survival approximately every 3 months for up to 3 years. (NCT02101021)
Latest
news: * On March 28, 2014, a Phase 3 trial sponsored by Gilead Sciences was published on the NIH website ClinicalTrials.gov for momelotinib and is currently recruiting participants.
