TRIAL DETAIL

ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST

Drug:
Trial Name:
ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Recruiting
Phase:
2
Start Date 12/01/2023
Age of Trial (yrs) 0
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT/PDGFRA/VEGF inhibitors
Strategy:
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
20201368
Sponsor:
University of Miami
Patient Contact:
Yvonne Enriquez-Nunez 305-243-0864 yxe97@med.miami.edu Jonathan Trent, MD, PhD 305-243-2581 JTrent@med.miami.edu
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
Criteria

Inclusion Criteria:

Patients who are ≥ 18 years of age.
Patients who have histologically confirmed metastatic or unresectable GIST. Unresectable GIST must be confirmed to be unresectable by an experienced surgeon.
Patients who received imatinib prior treatment regimens, including adjuvant therapy, with objective disease progression, inadequate clinical benefit, or intolerance. Additionally, disease progression or intolerance to other systemic therapies including investigational agents and radiotherapy is allowed. Patients who experienced intolerance to prior therapies must have objective disease progression prior to enrollment.

Exclusion Criteria:

Patients who have received prior treatment with sunitinib or regorafenib.
Patients who have received more than 2 different prior tyrosine kinase inhibitor (TKI) treatment regimens. If a patient receives the same TKI more than once sequentially (eg, imatinib followed by a period without systemic therapy and retreatment with imatinib), that will be counted as a single TKI treatment regimen.
Patients who are known to be KIT wild type.

Arms:

Experimental: Group A: KIT Exon 13 receiving Sunitinib
Participants with KIT mutation on exon 13 will receive Sunitinib (37.5 mg of Sunitinib orally (PO), once daily on a 28-day treatment cycle.
Other Names:). 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.

Experimental: Group B: KIT Exon 17 receiving Regorafenib
Participants with KIT mutation on exon 17 will receive Regorafenib (120.0 mg once daily three weeks on, one week off). 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.

Trial Links

Trial Results

Drug Information

Trial Sites

Name
Address
City
State
Zip
Country
1475 Northwest 12th Ave
Miami
FL
33136
USA