Clinical trial · Interventional
Study of Ruxolitinib in Pancreatic Cancer Patients
A Randomized Phase 2 Study of Ruxolitinib Efficacy and Safety in Combination With Capecitabine for Subjects With Recurrent or Treatment Refractory Metastatic Pancreatic Cancer (The RECAP Trial)
NCT01423604CI-TRIAL-00031633RECAPcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study was to determine whether ruxolitinib added to capecitabine is effective in improving the overall survival of patients with metastatic pancreatic cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
| Ruxolitinib | Drug | Ruxolitinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Capecitabine and ruxolitinib
- interventionNames
- Drug: Capecitabine
- Drug: Ruxolitinib
- type
- PLACEBO_COMPARATOR
- label
- Capecitabine and placebo
- interventionNames
- Drug: Capecitabine
- Drug: Placebo
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- Primary analysis includes study data from the start of the study (first dose for that subject) until the death of the subject (up to 8 months).
- description
- Overall survival was measured as the length of time (in days) between the randomization date and the date of death.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age or older * Diagnosis of metastatic pancreatic cancer; subjects must have had measurable, or evaluable disease that was histologically confirmed * Karnofsky performance status of ≥ 60 * Subjects must have failed 1st-line gemcitabine treatment for metastatic pancreatic cancer: o An alternate chemotherapeutic agent was an acceptable substitute as 1st-line therapy in the event that the subject was intolerant to or ineligible to receive gemcitabine * ≥ 2 weeks elapsed from the completion of previous chemotherapy, and subjects must have recovered or been at new stable baseline from any related toxicities Exclusion Criteria: * More than 1 prior chemotherapy regimen (not including adjuvant therapy) for metastatic disease * Evidence of central nervous system (CNS) metastases (unless stable for \> 3 months) or history of uncontrolled seizures * Ongoing radiation therapy or prior radiation therapy administered as a second-line treatment * Other active malignancy except basal or squamous carcinoma of the skin * Inability to swallow food or any condition of the upper GI tract that precluded administration of oral medications * Inadequate renal, hepatic and bone marrow function demonstrated by clinical observations and/or laboratory assessments
References
Publications (1)
- DERIVEDHurwitz HI, Uppal N, Wagner SA, Bendell JC, Beck JT, Wade SM 3rd, Nemunaitis JJ, Stella PJ, Pipas JM, Wainberg ZA, Manges R, Garrett WM, Hunter DS, Clark J, Leopold L, Sandor V, Levy RS. Randomized, Double-Blind, Phase II Study of Ruxolitinib or Placebo in Combination With Capecitabine in Patients With Metastatic Pancreatic Cancer for Whom Therapy With Gemcitabine Has Failed. J Clin Oncol. 2015 Dec 1;33(34):4039-47. doi: 10.1200/JCO.2015.61.4578. Epub 2015 Sep 8. PMID 26351344