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

Phase 1

• Conditions: Relapsed or refractory metastatic colorectal cancer; MedDRA version: 17.0Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 17.0Level: PTClassification code 10010030Term: Colorectal cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 17.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 17.0Level: PTClassification code 10061451Term: Colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-004714-18-ES
• Lead Sponsor: Incyte Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-16
• Last Update Posted: 23 January 2017

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