Overview

This trial is active, not recruiting.

Condition metastatic pancreatic ductal adenocarcinoma
Treatments momelotinib, placebo to match momelotinib, nab-paclitaxel, gemcitabine
Phase phase 3
Targets JAK, JAK1, JAK2
Sponsor Gilead Sciences
Start date June 2014
End date December 2016
Trial size 25 participants
Trial identifier NCT02101021, 2014-004480-20, GS-US-370-1296

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Participants will receive momelotinib plus nab-paclitaxel and gemcitabine.
momelotinib GS-0387
Momelotinib tablets administered orally once or twice daily
nab-paclitaxel
Nab-paclitaxel administered intravenously over approximately 30-40 minutes or as per institutional standard of care on Days 1, 8, and 15 of each cycle
gemcitabine
Gemcitabine administered intravenously over approximately 30 minutes or as per institutional standard of care on Days 1, 8, and 15 of each cycle
(Placebo Comparator)
Participants will receive placebo to match momelotinib plus nab-paclitaxel and gemcitabine.
placebo to match momelotinib
Placebo to match momelotinib tablets administered orally once or twice daily
nab-paclitaxel
Nab-paclitaxel administered intravenously over approximately 30-40 minutes or as per institutional standard of care on Days 1, 8, and 15 of each cycle
gemcitabine
Gemcitabine administered intravenously over approximately 30 minutes or as per institutional standard of care on Days 1, 8, and 15 of each cycle

Primary Outcomes

Measure
For the lead-in phase, the incidence of DLTs
time frame: Up to Day 28
For the randomized treatment phase, overall survival
time frame: Up to 3 years

Secondary Outcomes

Measure
For the lead-in phase, overall survival
time frame: Up to 3 years
For the lead-in phase, progression free survival
time frame: Up to 3 years
For the lead-in phase, overall response rate
time frame: Up to 3 years
For the randomized treatment phase, progression free survival
time frame: Up to 3 years
For the randomized treatment phase, overall response rate
time frame: Up to 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Presence of metastatic pancreatic adenocarcinoma plus 1 of the following: - Histological diagnosis of pancreatic adenocarcinoma confirmed pathologically, OR - Pathologist confirmed histological/cytological diagnosis of adenocarcinoma consistent with pancreas origin in conjunction with either: - The presence of a mass in the pancreas, OR - A history of resected pancreatic adenocarcinoma - Measurable disease per RECIST v1.1 - Adequate organ function defined as follows: - Total bilirubin ≤ 1.25 x upper limit of the normal range (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN - Absolute neutrophil count (ANC) > 1500 cells/mm^3, platelet > 100,000 cells/mm^3, hemoglobin > 9 g/dL - Serum creatinine < ULN OR calculated creatinine clearance (CrCl) of ≥ 60 ml/min - Eastern Cooperative Oncology Group (ECOG ) 0 or 1 - Modified Glasgow prognostic score (mGPS) of 1 or 2 at Screening (randomized phase only) Exclusion Criteria: - Neoadjuvant or adjuvant chemotherapy or chemoradiotherapy for pancreatic adenocarcinoma - Currently or previously treated with biologic, small molecule, immunotherapy, chemotherapy, or other agents for metastatic pancreatic carcinoma - Major surgery within 28 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) - Known positive status for HIV - Chronic active or acute viral hepatitis A, B, or C infection (testing required for hepatitis B and C), or hepatitis B or C carrier - Peripheral neuropathy ≥ Grade 2 - 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 - History of interstitial pneumonitis and/or require supplemental oxygen therapy - External biliary drain - Documented myocardial infarction or unstable/uncontrolled cardiac disease within 6 months of enrollment

Additional Information

Official title A Phase 3, Randomized, Double-blind, Placebo-controlled 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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Gilead Sciences.
Location data was received from the National Cancer Institute and was last updated in September 2016.