University of Miami
Jonathan Trent, MD, PhD
The purpose of this research is to test if mutations (changes in DNA) in exons (segment of DNA or RNA containing information that has the instructions for making proteins) in the KIT gene can be used to predict the body's response to standard of care treatment.
Gastrointestinal Stromal Tumors
Sunitinib
Regorafenib
Phase 2
Study Type : | Interventional |
Estimated Enrollment : | 48 participants |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | ctDNA-Guided Sunitinib And Regorafenib Therapy for Gastrointestinal Stromal Tumor (GIST) |
Actual Study Start Date : | October 17, 2023 |
Estimated Primary Completion Date : | December 2026 |
Estimated Study Completion Date : | December 2028 |
Arm | Intervention/treatment |
---|---|
Experimental: Group A: KIT Exon 13 receiving Sunitinib Participants with KIT mutation on exon 13 will receive Sunitinib. Participants showing disease progression after first-assigned Sunitinib therapy have the option to receive Regorafenib therapy. Total allotted time for treatment is up to 12 months. |
Drug: Sunitinib Drug: Regorafenib |
Experimental: Group B: KIT Exon 17 receiving Regorafenib Participants with KIT mutation on exon 17 will receive Regorafenib. Participants showing disease progression after first-assigned Regorafenib therapy have the option to receive Sunitinib therapy. Total allotted time for treatment is up to 12 months. |
Drug: Sunitinib Drug: Regorafenib |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
University of Miami
Miami, Florida, United States, 33136