A Study of Ruxolitinib in Pancreatic Cancer Patients
The registry record from ClinicalTrials.gov (public domain): summary, interventions, outcomes and eligibility. Questions are answered only with quotes from this document. Source: ClinicalTrials.gov, retrieved 2026-11-05.
Stopped earlyWhy stopped, per the registry: “The safety committee found no safety issues but recommended halting the study based on a lack of efficacy in a similar trial. The sponsor terminated the trial.”
Record metadata
- Phase
- Phase 3
- Status
- Terminated
- Start
- 2014-06
- End
- 2016-10
- Enrollment
- 86
- Sites
- 95
- Sponsor class
- INDUSTRY
- Results posted
- 2017-06-06
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Source text
Brief summary · public domain (ClinicalTrials.gov) · T1
This was to determine the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of metastatic pancreatic cancer.
Detailed description · public domain (ClinicalTrials.gov) · T1
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.
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: Ruxolitinib. 5 mg tablets to be administered by mouth twice daily (BID)
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: Placebo. 5 mg matching placebo tablets to be administered by mouth twice daily (BID)
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: Capecitabine. 150 mg or 500 mg tablets to be administered by mouth twice daily (BID)
Arm · public domain (ClinicalTrials.gov) · T1
Ruxolitinib plus capecitabine (experimental):
Arm · public domain (ClinicalTrials.gov) · T1
Placebo plus capecitabine (active comparator):
Primary outcome · public domain (ClinicalTrials.gov) · T1
Overall Survival (OS). Overall survival is reported here based on the number of deaths from randomization until the data cut-off. Time frame: Randomization until death due to any cause up to 6-months or to the data cutoff 11FEB2016..
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Progression Free Survival (PFS). Time frame: Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016..
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Percentage of Participants Achieving Progression Free Survival (PFS). Time frame: Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016..
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Objective Response Rate (ORR). Time frame: Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016..
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Duration of Response. Time frame: Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016..
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Participants With Treatment-Emergent Adverse Events (TEAEs). Time frame: Baseline through approximately 30 days post treatment discontinuation; up to 6-months or to the data cutoff 11FEB2016..
Eligibility · public domain (ClinicalTrials.gov) · T1
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 participants must have recovered or be at a new stable baseline from any related toxicities. * Radiographically measurable or evaluable disease * An modified Glasgow Prognostic Score (mGPS) of 1 or 2 as defined below: * Criteria: 1. mGPS of 1: C-reactive protein (CRP) \> 10 mg/L and albumin ≥ 35 g/L 2. mGPS of 2: CRP \> 10 mg/L and albumin \< 35 g/L 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). * Current or previous other malignancy within 2 years of study entry without sponsor approval * Prior severe reaction to fluoropyrimidines, known dihydropyrimidine dehydrogenase deficiency (DPD), or other known hypersensitivity to active substances, including fluorouracil (5-FU), ruxolitinib, or any of their excipients. * Prior treatment with a JAK inhibitor for any indication.
Enrollment · public domain (ClinicalTrials.gov) · T1
Enrollment: 86 participants (actual).
Why stopped · public domain (ClinicalTrials.gov) · T1
The safety committee found no safety issues but recommended halting the study based on a lack of efficacy in a similar trial. The sponsor terminated the trial.