Study of Ruxolitinib in Colorectal Cancer Patients
Condition: CRC (Colorectal Cancer)
MeSH terms: Colorectal Neoplasms
Intervention: Ruxolitinib; Regorafenib; Placebo
Intervention description: 5 mg tablets to be administered by mouth
Ruxolitinib 20 mg twice a day (BID) (Part 1) (NOTE: The starting dose for the randomized portion of study (Part 2) was 15 mg BID based on results from Part 1.); Regorafenib 160mg once daily for the first 21 days of each 28-day cycle. (NOTE: Dose interruptions and modifications for regorafenib are expected when toxicities occur in which dose interruptions or modifications are appropriate.); 5 mg matching placebo tablets to be administered by mouth
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 396.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic Colorectal Cancer; Colon Cancer; Ruxolitinib; adenocarcinoma; regorafenib; Jakavi ®; Jakafi ®; Stivarga ®

Summary:

      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.
    

Eligibility criteria:

        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.