Conditions: Pancreatic Cancer
Keywords: Metastatic pancreatic cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 86
Healthy volunteers: no

Brief 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.

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 matching placebo tablets to be administered by mouth twice daily (BID) intervention 3: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID)

Protocol document: