A Study of Ruxolitinib in Combination With Regorafenib in Subjects Metastatic Colorectal Cancer

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 420

Inclusion Criteria

• Male or female 18 years or older.
• 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; and progressed following the last administration of approved therapy.
• Radiographically measurable or evaluable disease (per RECIST 1.1).
• Eastern Cooperative Oncology Group 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.
• Radiotherapy to disease sites is allowed provided:
- Four or more weeks have elapsed since the completion of radiation therapy.
- Subjects who received palliative radiation treatment to a limited field or on an accelerated schedule within the last 7 days are eligible
- Disease sites within the field of prior irradiation have subsequently progressed or there are other metastatic disease sites outside the field of prior irradiation.
- All treatment related toxicities have resolved or are at a new stable baseline.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 210
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 210

Exclusion Criteria

Subjects who meet any of the following will not be included in the study:
• Received prior treatment with regorafenib.
• Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption of drugs.
• History of abdominal fistula or gastrointestinal perforation at any point within 6 months prior to day 1 of study drug administration, unless surgically repaired.
• Active peptic ulcer disease, inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), diverticulitis, or other gastrointestinal conditions with increased risk of perforation or gastrointestinal bleeding.
• Recent history (=4 weeks of Day 1 of study drug administration) of a major surgery or significant traumatic injury.
• Recent history (= 3 months) or ongoing partial or complete bowel obstruction unless corrected with surgery.
• Blood pressure = 140/90 mmHg
• Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment.
• Known central nervous system metastases or history of uncontrolled seizures.
• 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.
• Creatinine clearance < 50 mL/min measured or calculated by Cockroft-Gault equation
• Inadequate hepatic, and bone marrow function as evidenced by:
- Absolute neutrophil count < 1.5 × 109/L.
- Platelets < 100 × 109/L.
- Hemoglobin < 9 g/dL (transfusions are permitted to achieve baseline hemoglobin level).
- ALT/AST > 2.5 × the upper limit of normal (ULN); or > 5 × ULN in the presence of liver metastases.
- Total bilirubin > 1.5 × ULN (if total bilirubin is > 1.5 × ULN then the subject may participate if the direct bilirubin is = 1.5 × ULN).
• Concurrent anticancer therapy
• Subjects who participated in any other study in which an investigational study drug was received within 28 days prior to first dose.
• Current or previous other malignancy within 5 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive malignancy.
• Known HIV infection.
• HBV or HCV viremia or at risk for HBV or HCV reactivation.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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