Phase II study comparing sorafenib to placebo when administered in combination with chemotherapy for the treatment of metastatic colorectal cancer in Subjects Who Have Not Been Previously Treated for Stage IV Disease

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Extrait

The objective of this phase 2 study is to evaluate the antitumor activity, safety, and tolerability of sorafenib versus placebo when used in combination with mFOLFOX6 (5-fluorouracil [5-FU], levo-leucovorin [LLV], and oxaliplatin) in subjects with mCRC who have not been previously treated for Stage IV disease. The primary efficacy objective is to compare progression-free survival (PFS) in subjects receiving sorafenib in combination with mFOLFOX6 versus subjects receiving placebo in combination with mFOLFOX6.

Critère d'inclusion

The patient population includes patients with Stage IV metastatic colorectal cancer (mCRC), with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. Patients must have measurable disease and must not have received prior systemic anticancer therapy for mCRC

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Kusajili – Centralise les essais cliniques mondiaux

Phase II study comparing sorafenib to placebo when administered in combination with chemotherapy for the treatment of metastatic colorectal cancer in Subjects Who Have Not Been Previously Treated for ...