Last updated 11 days ago
(Peak) a Phase 3 Randomized Trial of CGT9486+Sunitinib Vs. Sunitinib in Subjects with Gastrointestinal Stromal Tumors
442 patients around the world
Available in Brazil, Argentina, Chile
Cogent Biosciences, Inc.
10Research sites
442Patients around the world
This study is for people with
Gastrointestinal stromal tumors
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Histologically confirmed locally advanced, metastatic, and/or unresectable GIST. Molecular pathology report must be available for Part 2; if molecular pathology report is unavailable or inadequate, an archival or fresh tumor tissue sample will be required to evaluate mutational status prior to randomization.Documented disease progression on or intolerance to imatinibSubjects must have received the following treatment:1. Part 1a: Treatment with ≥1 prior lines of therapy for GIST2. Part 1b: Treatment with ≥2 prior TKI for GISTs- Part 2: Prior treatment with imatinib onlyHave at least 1 measurable lesion according to mRECIST v1.1ECOG - 0 to 2Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits
- Known PDGFR driving mutations or known succinate dehydrogenase deficiencyClinically significant cardiac diseaseMajor surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drugGastrointestinal abnormalities including, but not limited to, significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorptionAny active bleeding excluding hemorrhoidal or gum bleedingSeropositive for HIV 1 or 2, or positive for hepatitis B surface antigen or hepatitis C virus (HCV) antibody.Active, uncontrolled, systemic bacterial, fungal, or viral infections at ScreeningReceived strong CYP3A4 inhibitors or inducersReceived sunitinib within 3 weeks (Part 1a, Part 1b)
Sites
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Instituto Oncológico de Córdoba IONC - Fundación Richardet Longo
Recruiting
Centro de Estudos e Pesquisas de Hematologia e Oncologia - CEPHO
Recruiting
Hospital de Clínicas - Universidade Estadual de Campinas - UNICAMP
Recruiting
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA
Recruiting
Instituto Oncológico FALP (Fundación Arturo Lopez Perez)
Recruiting
Centro de Oncología de Precisión
Recruiting
Centro de Investigación Médica Aguascalientes - CIMA
Recruiting
I CAN Oncology Center
Recruiting
Oaxaca Site Management Organization S.C.
Recruiting
SponsorCogent Biosciences, Inc.
Conditions
Gastrointestinal stromal tumors
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05208047
