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Stivarga (Regorafenib) - Summary



Regorafenib is a small molecule inhibitor of multiple membrane-bound and intracellular kinases involved in normal cellular functions and in pathologic processes such as oncogenesis, tumor angiogenesis, and maintenance of the tumor microenvironment.

StivargaŽ is indicated for the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.

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Published Studies Related to Stivarga (Regorafenib)

Regorafenib in gastrointestinal stromal tumors. [2014]
Gastrointestinal stromal tumors (GIST) are the most common mesenchymal tumors of the GI tract and constitute less than 1% of all digestive tract tumors--the stomach is the most common site. Regorafenib is a multi-tyrosine kinase inhibitor with regulatory approvals granted for colorectal cancers and GIST...

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Clinical Trials Related to Stivarga (Regorafenib)

The Safety and Efficacy Study of Regorafenib (CT) Compared With Regorafenib (STIVARGA) in Patients With Solid Tumors [Active, not recruiting]

Effects of LBM and PPIs on Pharmacokinetics and Safety of Regorafenib (BAY 73-4506) in Cancer Patients [Not yet recruiting]
The FDA and Health Canada have approved regorafenib at a daily dose of 160mg for the treatment of metastatic colorectal cancer and gastrointestinal stromal cancer; however, the 160 mg dose is not well tolerated by patients, especially women. The purpose of this study is to determine if lean body mass and acidity in the intestinal tract impact how regorafenib is absorbed into the bloodstream and then broken down and removed from the body. This may explain the side effects experienced at the 160 mg dose, especially by women, and inform regorafenib dosing in the future.

Regorafenib and Cetuximab in Patients With Advanced Malignancy [Recruiting]
The goal of this clinical research study is to find the highest tolerable dose of the combination of regorafenib and cetuximab that can be given to patients with advanced solid tumors. The safety and effectiveness of this drug combination will also be studied.

Single Agent Regorafenib in Refractory Advanced Biliary Cancers [Recruiting]
The main purpose of this study is to see if regorafenib can help control or decrease cancer size in patients with cancer of the bile duct. Researchers also want to find out if regorafenib is safe and tolerable.

Safety and Pharmacokinetics of Regorafenib and Cetuximab in Combination [Recruiting]

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Page last updated: 2015-08-10

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