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| Sponsor: | Dana-Farber Cancer Institute |
|---|---|
| Collaborators: |
Brigham and Women's Hospital Massachusetts General Hospital Fox Chase Cancer Center Oregon Health and Science University Jonsson Comprehensive Cancer Center Bayer |
| Information provided by: | Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT01068769 |
Purpose
The purpose of this research study is to determine the safety and activity of regorafenib in participants with advanced gastrointestinal stromal tumor (GIST) if the standard approved therapies, imatinib and sunitinib, have failed to control the disease. Regorafenib is a drug that blocks abnormally active signaling enzymes called "tyrosine kinases" which are important to the growth of GIST. This "tyrosine kinase inhibition" is similar to the way that both imatinib and sunitinib work; however, regorafenib blocks certain additional signaling pathways that are not blocked by imatinib or sunitinib. Regorafenib has been not been tested in GIST participants before this research study.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastrointestinal Stromal Tumor |
Drug: regorafenib |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Non-randomized, Open Label, Multi-center Phase II Study Evaluating the Efficacy and Safety of Regorafenib in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor (GIST), Resistent or Intolerant to at Least Imatinib and Sunitinib |
| Estimated Enrollment: | 34 |
| Study Start Date: | February 2010 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
More Information
| Responsible Party: | Suzanne George, MD, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT01068769 History of Changes |
| Other Study ID Numbers: | 09-400 |
| Study First Received: | February 12, 2010 |
| Last Updated: | January 21, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
regorafenib GIST |
|
Gastrointestinal Stromal Tumors Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases |