TRIAL DETAIL

(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors

Drug:
Trial Name:
(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Recruiting
Phase:
3
Start Date 01/27/2022
Age of Trial (yrs) .3
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT inhibitor
Strategy:
Inhibit all resistant KIT/PDGFRa mutations
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
CGT9486-21-301 Peak
Sponsor:
Cogent Biosciences, Inc.
Patient Contact:
Shaun Mitchell 973-220-4291 shaunica.mitchell@cogentbio.com
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
Brief Summary:
This is a Phase 3, open-label, international, multicenter study of CGT9486 in combination with sunitinib. This is a multi-part study that will enroll approximately 388 patients. Part 1 consists of two evaluations: 1) confirming the dose of an updated formulation of CGT9486 to be used in subsequent parts in approximately 20 patients who have received multiple prior lines of therapy and 2) evaluating for drug-drug interactions between CGT9486 and sunitinib in approximately 18 patients who have received at least two prior lines of therapy. The second part of the study will enroll up to 350 patients who are intolerant to, or who failed prior treatment with, imatinib only and will compare the efficacy of CGT9486 plus sunitinib to sunitinib alone with patients being randomized in a 1:1 manner.

Partial Eligibility Criteria - Check full criteria in the NCT listing:

Key Inclusion Criteria:

Histologically confirmed locally advanced, metastatic, and/or unresectable GIST
Documented disease progression on or intolerance to imatinib
Have at least 1 measurable lesion according to mRECIST v1.1
ECOG - 0 to 2
Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits

Key Exclusion Criteria:

Prior treatment with < 2 Tyrosine Kinase Inhibitors (TKIs) (Part 1b only)
Prior treatment with any TKI other than imatinib (Part 2 only)
Known PDGFR alpha D842V mutation or known succinate dehydrogenase deficiency ...
......

Trial Links

Trial Results

Drug Information

AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics - Corporate Presentation January 2022
 

Trial Sites

Name
Address
City
State
Zip
Country
Orange City
FL
32763
USA
Toledo
OH
43614
USA