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

Completed · Phase 3 · Has a placebo group

Conditions studied: Metastatic Colorectal Cancer

In brief

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

Key facts

Study ID

NCT01103323

Run by

Bayer

People needed

760

Starts

2010-04-01

Expected to finish

2014-01-01

Last updated by the study team

2015-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 </= 1
• Life expectancy of at least 3 months
• Adequate bone marrow, liver and renal function

You may not qualify if…

• 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 </= Grade 2

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Mission Hills, California, United States
• Study site — Orange, California, United States
• Study site — Redlands, California, United States
• Study site — Santa Maria, California, United States
• Study site — Aventura, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Peoria, Illinois, United States
• Study site — Cedar Rapids, Iowa, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Rochester, Minnesota, United States
• Study site — Saint Cloud, Minnesota, United States
• Study site — Jefferson City, Missouri, United States
• Study site — Neptune City, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Fargo, North Dakota, United States
• Study site — Toledo, Ohio, United States
• Study site — Scranton, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — Sumter, South Carolina, United States
• Study site — Dallas, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Beverly Hills, California, United States

Full record on ClinicalTrials.gov

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