Regorafenib in Subjects With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy (CONSIGN)
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.
|Study Type:||Expanded Access What is Expanded Access?|
|Official Title:||An Open-label Phase IIIb Study of Regorafenib in Patients With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01538680
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|Study Director:||Bayer Study Director||Bayer|