GS-US-370-1296,Study of Gemcitabine& Nab-paclitaxel
Research type
Research Study
Full title
A Phase 2, Randomized, Double-blind Study of Gemcitabine and Nab-paclitaxel combined with Momelotinib in Subjects with Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma Preceded by a Dose-finding, Lead-in Phase
IRAS ID
188050
Contact name
Harpreet Wasan
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2014-004480-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 8 months, 1 days
Research summary
The purpose of this study is to test the safety and effectiveness of Momelotinib (MMB) in combination with nab-paclitaxel and gemcitabine.
We want to find out what effects, good and/or bad, MMB has on metastatic (the transfer of a disease from one part of the body to another) pancreatic cancer when it is given with nab-paclitaxel and gemcitabine.
Nab-paclitaxel and gemcitabine are prescription drugs that help prevent cancer cells from dividing and growing. This treatment is licenced for use in advanced pancreatic cancer in the UK, although, it is not routinely available on the NHS throughout the UK.
This study is open to male and female patients, who are at least 18 years of age and meet the study requirements.
There will be approximately 336 patients who will be included in the study at about 125 selected study sites.
The first 9-36 patients on this study will receive different doses of MMB in combination with different doses of nab-paclitaxel and gemcitabine. They are tested against each other to establish which dose works best and/or is least harmful. Three patients will take a starting dose in Dose Level 1. If this dose level is well tolerated by all 3 patients during the first 28 days (Cycle 1) of treatment, then the next 3 patients will enrol into a higher dose level, Dose Level 2. This will continue until a maximum tolerated dose (MTD)—that is, the highest dose given without causing serious side effects is defined.
The next 300 patients will be randomised (like flipping a coin), to receive one of two treatments - either the experimental drug MMB in combination with nab-paclitaxel and gemcitabine; or placebo in combination with nab-paclitaxel and gemcitabine. Patients will have a 50% chance to receive MMB or placebo in combination with nab-paclitaxel and gemcitabine.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
15/EE/0388
Date of REC Opinion
14 Dec 2015
REC opinion
Further Information Favourable Opinion