This trial is active, not recruiting.

Condition metastatic pancreatic adenocarcinoma
Treatments ruxolitinib, placebo, capecitabine
Phase phase 3
Targets JAK, JAK1, JAK2
Sponsor Incyte Corporation
Start date March 2014
End date February 2016
Trial size 318 participants
Trial identifier NCT02117479, INCB 18424-362


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
ruxolitinib Jakafi ®
5 mg tablets to be administered by mouth twice daily [BID] 15 mg BID
500 mg tablets to be administered by mouth twice daily [BID]
(Active Comparator)
500 mg tablets to be administered by mouth twice daily [BID]
500 mg tablets to be administered by mouth twice daily [BID]

Primary Outcomes

Overall Survival (OS)
time frame: Randomization until death due to any cause. Approximately 21 months.

Secondary Outcomes

Progression-free survival (PFS)
time frame: Randomization to disease progression, or death due to any cause if sooner. Approximately 21 months.
Objective Response Rate (ORR)
time frame: Baseline through end of study. Approximately 21 months.
Duration of Response
time frame: Baseline through end of study. Approximately 21 months.
Safety and tolerability of the treatment regimens assessed by a summary of adverse events and clinical laboratory assessments.
time frame: Baseline through approximately 30 days post treatment discontinuation. Approximately 21 months.

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologically or cytologically confirmed adenocarcinoma of the pancreas. - Advanced adenocarcinoma of the pancreas that is inoperable or metastatic. - Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 - Received 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy). - ≥ 2 weeks elapsed from the completion of previous treatment regimen and subjects must have recovered or be at a new stable baseline from any related toxicities. - Radiographically measurable or evaluable disease - An mGPS of 1 or 2 as defined below: - Criteria: - C-reactive protein >10 mg/L AND albumin ≥35 g/L; Score = 1 - C-reactive protein >10 mg L AND albumin <35 g/L; Score = 2 Exclusion Criteria: - Received more than 1 prior regimen for advanced or metastatic disease. - Ongoing radiation therapy, radiation therapy administered within 30 days of enrollment. - Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization). - Prior severe reaction to fluoropyrimidines, known dihydropyrimidine dehydrogenase deficiency (DPD), or other known hypersensitivity to active substances, including fluorouracil (5-FU), or Ruxolitinib, or any of their excipients. - Prior treatment with a JAK inhibitor for any indication.

Additional Information

Official title A Randomized, Double-Blind, Phase 3 Study of the Janus Kinase (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 1 Study)
Description This is a randomized, double-blinded, placebo-controlled, Phase 3 study, in which approximately 310 subjects with advanced or metastatic adenocarcinoma of the pancreas who have failed, or were intolerant to first-line chemotherapy, will be randomized (1:1) to one of the following treatment groups: - Treatment A (N = 155): Capecitabine + ruxolitinib - Treatment B (N = 155): Capecitabine + placebo Treatment will consist of repeating 21-day cycles. Capecitabine will be self-administered for the first 14 days of each cycle, and ruxolitinib/placebo will be self-administered during the entire cycle. Treatment for all subjects will continue as long as the regimen is tolerated, and the subject does not meet discontinuation criteria. Subjects who discontinue treatment will continue to be followed for subsequent anticancer treatments and survival.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Incyte Corporation.