Clinical trial · Interventional
Study of Ruxolitinib in Colorectal Cancer Patients
A Randomized, Double-Blind Study of Ruxolitinib or Placebo in Combination With Regorafenib in Subjects With Relapsed or Refractory Metastatic Colorectal Cancer
NCT02119676CI-TRIAL-00031651terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Substudy 1 was terminated for futility at interim analysis and Substudy 2 was terminated per sponsor decision.
Summary
Brief summary (as posted)
The purpose of this study was to determine if ruxolitinib, in combination with regorafenib, is safe and effective in the treatment of metastatic colorectal 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 |
|---|---|---|---|
| CRC (Colorectal Cancer) | Colorectal Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Regorafenib | Drug | Regorafenib | ALIAS |
| Ruxolitinib | Drug | Ruxolitinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ruxolitinib plus regorafenib
- interventionNames
- Drug: Ruxolitinib
- Drug: Regorafenib
- type
- ACTIVE_COMPARATOR
- label
- Placebo plus regorafenib
- interventionNames
- Drug: Regorafenib
- Drug: Placebo
Primary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- Baseline until death due to any cause; up to 16 months or data cut-off 11 FEB 2016.
- description
- Overall survival is defined as the time from randomization to death due to any cause. Participants without death observed at the time of the analysis will be censored at last date known to be alive. The median overall survival time was estimated using the Kaplan-Meier method. Overall survival was compared between treatment groups using log-rank test.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is metastatic. * Previous treatment with fluoropyrimidine-, oxaliplatin- and irinotecan- based chemotherapy, an anti-VEGF therapy (if no contraindication) and if KRAS wild type and no contraindication, an anti-EGFR therapy. * Radiographically measurable or evaluable disease (per RECIST v1.1) * Life expectancy of ≥ 12 weeks. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * Three or more weeks have elapsed from the completion of previous treatment regimen and subjects must have recovered or be at a new stable baseline from any related toxicities. * Prior radiotherapy to disease sites is allowed with certain protocol-defined restrictions. Exclusion Criteria: * Prior treatment with regorafenib. * Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption of drugs. * Active peptic ulcer disease, inflammatory bowel disease (eg, ulcerative colitis, Crohn's disease), diverticulitis, or other gastrointestinal conditions with increased risk of perforation or gastrointestinal bleeding. * Recent history (≤ 3 months) or ongoing partial or complete bowel obstruction unless due to disease under study and corrected with surgery. * Blood pressure ≥ 140/90 mmHg. * Active bleeding diathesis or history of any major bleeding (eg, requiring transfusion of red blood cells (RBCs), central nervous system (CNS) bleeding, or significant hemoptysis within 6 months of enrollment. Subjects with bleeding secondary to underlying disease (including gastrointestinal (GI) perforation or fistula) that has been corrected by surgery or alternative procedure may be included. * Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months from Day 1 of study drug administration, New York Heart Association Class II, III, or IV congestive heart failure, and arrhythmia requiring therapy.
References
Publications (0)
Data not yet available
No reference posted for this study.