NCT02117479

Study of Ruxolitinib in Pancreatic Cancer Patients (Janus 1)

A Randomized, Double-Blind, Phase 3 Study of the JAK1/2 Inhibitor, Ruxolitinib or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic Adenocarcinoma of the Pancreas Who Have Failed or Are Intolerant to First-Line Chemotherapy (The JANUS 1 Study)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 321 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Determining the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of advanced or metastatic pancreatic cancer.

Detailed description

This was a randomized, double-blinded, placebo-controlled, Phase 3 study, in which approximately 310 participants with advanced or metastatic adenocarcinoma of the pancreas who have failed, or were intolerant to first-line chemotherapy, were to be randomized (1:1) to one of the following treatment groups: * Treatment A (N = 155): Capecitabine + ruxolitinib * Treatment B (N = 155): Capecitabine + placebo Treatment consisted of repeating 21-day cycles. Capecitabine was self-administered for the first 14 days of each cycle, and ruxolitinib/placebo was self-administered daily for each cycle. Treatment for all participants continued as long as the regimen was tolerated, and the participant did not meet discontinuation criteria. Participants who discontinued study treatment before study termination were monitored for safety up to 30-35 days from the end of treatment. All participants were followed for survival until study termination or the safety follow-up visit.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Ruxolitinib	5 mg tablets to be administered by mouth twice daily (BID)
DRUG	Placebo	5 mg tablets to be administered by mouth twice daily (BID)
DRUG	Capecitabine	150 and 500 mg tablets to be administered by mouth twice daily (BID)

Timeline

• Start date: 2014-03-01
• Primary completion: 2016-02-01
• Completion: 2016-12-01
• First posted: 2014-04-21
• Last updated: 2019-03-26
• Results posted: 2017-07-11

Locations

230 sites across 12 countries: United States, Australia, Belgium, Canada, Germany, Italy, New Zealand, South Korea, Spain, Taiwan, Thailand, United Kingdom