Colorectal Cancer

Study of Ruxolitinib in Colorectal Cancer Patients

Incyte Study ID:
INCB18424-267
CT.gov ID:
NCT02119676
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1-855-463-3463
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Clinical Study Purpose

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.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Colorectal Cancer
    • PRODUCT
  • Drug: Ruxolitinib
  • Drug: Regorafenib
  • Drug: Placebo
    • COLLABORATORS
    N/A
    DATE
    Mar 2014 - Feb 2016
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Key Inclusion and Exclusion 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.

    Exclusion Criteria

    • Prior treatment with regorafenib.
    • Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption of drugs.

    Clinical Study Locations

    Location
    Status
    Location
    Chandler, AZ, US
    Status
    Active, not recruiting
    Location
    Gilbert, AZ, US
    Status
    Active, not recruiting
    Location
    Mesa, AZ, US
    Status
    Active, not recruiting
    Location
    Scottsdale, AZ, US
    Status
    Active, not recruiting
    Location
    Los Angeles, CA, US
    Status
    Active, not recruiting
    Location
    Pasadena, CA, US
    Status
    Active, not recruiting

    Protocol Summary

    Incyte Study ID:
    INCB18424-267
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Double (Participant, Investigator)
    Interventions:
    Drug
    Enrollment:
    396
    Primary Outcome
    Open
    Secondary Outcome
    Open