ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST

ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST

Gastrointestinal Stromal Tumor

Recruiting

2

Start Date 09/30/2022

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

Arms and Interventions (partial):

Experimental: Group A: KIT Exon 13 receiving Sunitinib
Participants with KIT mutation on exon 13 will receive Sunitinib 37.5 mg. 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 120 mg
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.


Partial Criteria - See NCT listing for full 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.
Patients who have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2.
Patient, or legal guardian if permitted by local regulatory authorities, who provides informed consent to participate in the study.
Presence of proto-oncogene c-KIT (KIT) exon 13 or 17 secondary mutation will be determined through a circulating tumor DNA (ctDNA) blood test or biopsy performed as per standard of care.

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.