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Regorafenib in Subjects With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy (CONSIGN)

Expanded access is no longer available for this treatment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01538680
First Posted: February 24, 2012
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
February 21, 2012
February 24, 2012
October 12, 2017
 
Regorafenib in Subjects With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy

This is a phase III B, prospective, interventional, open-label, single-arm, multicenter study to provide regorafenib to subjects diagnosed with metastatic colorectal cancer who have failed after standard therapy and for whom no therapy alternatives exist, in the time between positive results and approval / availability on the market, and to collect safety data for regorafenib until market access.

Regorafenib is an oral (i.e. taken by mouth) multi-targeted kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, regorafenib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning.

The primary endpoint of this study will be safety.

Not Provided
Expanded Access
Drug: Regorafenib (BAY73-4506)

Subjects will receive 160 mg regorafenib po every day (qd) for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off). Subjects will continue on treatment until at least one of the following occurs (main criteria):

Progressive Disease (PD). The subject may continue treatment at the investigator's discretion.

Death Unacceptable toxicity Subject withdraws consent Treating physician determines discontinuation of treatment is in the subject's best interest Substantial non-compliance with the protocol

Not Provided
 
No longer available
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belgium,   Canada,   Czechia,   Denmark,   Finland,   France,   Germany,   Greece,   Hungary,   Ireland,   Israel,   Italy,   Mexico,   Netherlands,   Norway,   Poland,   Portugal,   Russian Federation,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
Czech Republic
 
NCT01538680
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
October 2017