Conditions: Pancreatic Cancer
Keywords: Metastatic pancreatic cancer Metastatic pancreatic adenocarcinoma that is recurrent
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 321
Healthy volunteers: no

Brief 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.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Ruxolitinib intervention 2: Placebo intervention 3: Capecitabine
Intervention descriptions: intervention 1: 5 mg tablets to be administered by mouth twice daily (BID) intervention 2: 5 mg tablets to be administered by mouth twice daily (BID) intervention 3: 150 and 500 mg tablets to be administered by mouth twice daily (BID)

Protocol document: