ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST

ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST

Gastrointestinal Stromal Tumor

Recruiting

2

Start Date 07/01/2023

Age of Trial (yrs) -.1

Gleevec-resistant

KIT/PDGFRA/VEGF inhibitors

Specifically GIST and only GIST

20201368

University of Miami

Yvonne Enriquez-Nunez 305-243-0864 yxe97@med.miami.edu Jonathan Trent, MD, PhD 305-243-2581 JTrent@med.miami.edu

Oral

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.