Clinical trialPhase 3Terminated
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)
- Outcome
- Stopped earlyThe study was terminated early based on the results of the planned interim analysis. (Other)
- Phase
- Phase 3
- Status
- Terminated
- Study type
- Interventional
- Start
- March 2014
- Expected end
- December 2016
- Enrollment
- 321 participants
- Sites
- 230
- Primary outcomes
- Overall Survival (OS)
- Sponsor
- Industry
- Results posted
- 2017-07-11
- Last update
- 26 March 2019
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Brief summary public domain (ClinicalTrials.gov)
Determining the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of advanced or metastatic pancreatic cancer.
Detailed description public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS) [Randomization until death due to any cause; up to the data cutoff 11FEB2016.]. Count Of Participants, Participants. Observed: Ruxolitinib Plus Capecitabine (n=161): 113; Placebo Plus Capecitabine (n=160): 124. Censored: Ruxolitinib Plus Capecitabine (n=161): 48; Placebo Plus Capecitabine (n=160): 36. Analysis, Ruxolitinib Plus Capecitabine vs Placebo Plus Capecitabine: Hazard Ratio (HR) 0.969 (95% CI 0.747 to 1.256); other.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression-free Survival (PFS) [Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.]. Median, days (95% Confidence Interval). Ruxolitinib Plus Capecitabine (n=161): 43.0 (41.0 to 46.0); Placebo Plus Capecitabine (n=160): 44.0 (42.0 to 48.0). Analysis, Ruxolitinib Plus Capecitabine vs Placebo Plus Capecitabine: Hazard Ratio (HR) 1.056 (95% CI 0.827 to 1.348); other.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Percentage of Participants Achieving Progression Free Survival (PFS) [Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.]. Median, percentage of participants (95% Confidence Interval). Survival rate at 3 months: Ruxolitinib Plus Capecitabine (n=161): 18.9 (12.7 to 25.9); Placebo Plus Capecitabine (n=160): 19.8 (13.6 to 26.8). Survival rate at 6 months: Ruxolitinib Plus Capecitabine (n=161): 6.1 (2.5 to 12.2); Placebo Plus Capecitabine (n=160): 5.7 (2.3 to 11.3). Survival rate at 9 months: Ruxolitinib Plus Capecitabine (n=161): 2.5 (0.5 to 7.5); Placebo Plus Capecitabine (n=160): 3.4 (1.0 to 8.5). Survival rate at 12 months: Ruxolitinib Plus Capecitabine (n=161): 2.5 (0.5 to 7.5); Placebo Plus Capecitabine (n=160): NA (NA to NA) [PFS was not evaluable in the placebo group due to the insufficient number of participants with events.].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Objective Response Rate (ORR) [Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.]. Number, percentage of participants. Objective response: Ruxolitinib Plus Capecitabine (n=161): 3.7; Placebo Plus Capecitabine (n=160): 1.9. Complete response: Ruxolitinib Plus Capecitabine (n=161): 0; Placebo Plus Capecitabine (n=160): 0. Partial response: Ruxolitinib Plus Capecitabine (n=161): 3.7; Placebo Plus Capecitabine (n=160): 1.9.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Duration of Response [Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.]. Median, days (95% Confidence Interval). Ruxolitinib Plus Capecitabine (n=161): NA (NA to NA) [The median duration of response was not evaluable in the treatment group due to the insufficient number of participants with events.]; Placebo Plus Capecitabine (n=160): NA (NA to NA) [The median duration of response was not evaluable in the treatment group due to the insufficient number of participants with events.].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Participants With Treatment-Emergent Adverse Events (TEAEs) [Baseline through approximately 30 days post treatment discontinuation; up to 6-months or to the data cutoff 11FEB2016.]. Count Of Participants, Participants. Participants who had any TEAEs: Ruxolitinib Plus Capecitabine (n=153): 152; Placebo Plus Capecitabine (n=154): 152. Participants who had treatment-related TEAEs: Ruxolitinib Plus Capecitabine (n=153): 73; Placebo Plus Capecitabine (n=154): 59. Participants who had SAEs: Ruxolitinib Plus Capecitabine (n=153): 94; Placebo Plus Capecitabine (n=154): 83. Participants who had Grade 3 or higher TEAEs: Ruxolitinib Plus Capecitabine (n=153): 112; Placebo Plus Capecitabine (n=154): 113. Participants hospitalized because of a TEAE: Ruxolitinib Plus Capecitabine (n=153): 89; Placebo Plus Capecitabine (n=154): 75. Participants discontinued treatment due to TEAE: Ruxolitinib Plus Capecitabine (n=153): 12; Placebo Plus Capecitabine (n=154): 22. Participants with a dose modification due to TEAE: Ruxolitinib Plus Capecitabine (n=153): 68; Placebo Plus Capecitabine (n=154): 48. Participants on concomitant medication due to TEAE: Ruxolitinib Plus Capecitabine (n=153): 131; Placebo Plus Capecitabine (n=154): 122. Participants with procedure performed due to TEAE: Ruxolitinib Plus Capecitabine (n=153): 60; Placebo Plus Capecitabine (n=154): 46. Participants who had a fatal TEAE: Ruxolitinib Plus Capecitabine (n=153): 20; Placebo Plus Capecitabine (n=154): 15.