NCT02119663

A Study of Ruxolitinib in Pancreatic Cancer Patients

A Randomized, Double-Blind, Phase 3 Study of the JAK 1/2 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 2 Study)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was to determine the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of metastatic pancreatic cancer.

Detailed description

This was a randomized, double-blinded, placebo-controlled, Phase 3 study, in which approximately 270 participants with advanced or metastatic adenocarcinoma of the pancreas who had failed or were intolerant to first-line chemotherapy were to be randomized (1:1) to one of the following treatment groups: * Treatment A (N = 135): Capecitabine + ruxolitinib * Treatment B (N = 135): 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 during the entire cycle. Treatment for all participants was to continue as long as the regimen was tolerated, and the participant did not meet discontinuation criteria. Participants who discontinued treatment continued to be followed for subsequent anticancer treatments and survival.

Conditions

• Pancreatic Cancer

Interventions

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

Timeline

• Start date: 2014-06-01
• Primary completion: 2016-02-01
• Completion: 2016-10-01
• First posted: 2014-04-22
• Last updated: 2018-02-13
• Results posted: 2017-06-06

Locations

95 sites across 14 countries: United States, Austria, Chile, Colombia, Denmark, France, Ireland, Israel, Mexico, Netherlands, Portugal, Puerto Rico, Sweden, Switzerland