Patients With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blind, placebo-controlled multi-center phase III study to evaluate efficacy and safety of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed on/after all approved drugs for CRC

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer

Criteria

Inclusion Criteria:

• Histological or cytological documentation of adenocarcinoma of the colon or rectum

• Progression during or within 3 months following the last administration of approved standard therapies. Patients treated with oxaliplatin in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy

• Patients with measurable or non measurable disease

• Eastern Cooperative Oncology Group (ECOG) Performance Status of
• Life expectancy of at least 3 months

• Adequate bone marrow, liver and renal function

Exclusion Criteria:

• Unstable/uncontrolled cardiac disease

• History of arterial or venous thrombotic or embolic events

• Symptomatic metastatic brain or meningeal tumors

• Patients with evidence or history of bleeding diathesis

• Interstitial lung disease - Persistent proteinuria >/= grade 3

• Unresolved toxicity > grade 1 attributed to any prior therapy/procedure excluding alopecia and oxaliplatin induced neurotoxicity