Phase 2b, DB, Randomized Study Evaluating Efficacy & Safety of Sorafenib Compared With Placebo When Administered in Combination With Modified FOLFOX6 for the Treatment of Metastatic CRC Subjects Previously Untreated for Stage IV Disease
Phase 2b, DB, Randomized Study Evaluating Efficacy & Safety of Sorafenib Compared With Placebo When Administered in Combination With Modified FOLFOX6 for the Treatment of Metastatic CRC Subjects Previously Untreated for Stage IV Disease
To determine if sorafenib when added to chemotherapy will slow disease progression more than chemotherapy alone in patients previously untreated for metastatic colorectal cancer.
Inclusion Criteria:
Exclusion Criteria:
Prior treatment with sorafenib
Clinical or radiographic evidence of brain metastasis
Major surgery, surgical biopsy, or significant traumatic injury within 28 days of randomization; evidence or history of bleeding diathesis or coagulopathy
Red blood cell (RBC), white blood cell (WBC), or platelet transfusions and/or growth factor use within 28 days before randomization
Adjuvant therapy for CRC (Stage I, II, or III) completed within 12 months before randomization
Serious, non-healing wound, ulcer, or bone fracture; Grade 3 or 4 hemorrhage within 28 days before randomization
Use of anticoagulation therapy (low dose anticoagulation therapy to mitigate risk of thrombosis due to placement of a semi-permanent central venous port for administration of chemotherapy is allowed. The use of coumadin and related compounds is excluded.)
Uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic pressure > 100 mmHg on repeated measurement) despite optimal medical management
Thrombolic, embolic, venous, or arterial events (eg, cerebrovascular accident, including transient ischemic attacks) within 6 months before randomization
Active cardiac disease including:
Peripheral neuropathy > Grade 1 (CTCAE)
Known HIV infection or chronic hepatitis B or C infection
Any active infection >/= Grade 2 (CTCAE)
Any medical, psychological, or social condition that may interfere with the subject's participation in the study or evaluation of the study results
Use of any investigational drug within 28 days or 5 half-lives of that drug, whichever is longer, before randomization
Subjects with metastatic CRC who are currently candidates for surgery with curative intent
Bruxelles - Brussel, 1000, Belgium
Bruxelles - Brussel, 1070, Belgium
Craiova-Dolj, 200535, Romania
Pjatygorsk, 357502, Russia