CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 51 enrolled
Drug / intervention
CGT9486 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02401815
NCT02401815Phase 2Completed

A Phase 1b and 2a Study to Assess Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of CGT9486 as a Single Agent and in Combination With PLX3397 or Sunitinib (Sutent®) in Patients With Advanced Solid Tumors and Patients With Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumor (GIST) Who Have Been Previously Treated With Imatinib Mesylate/KIT-Directed Tyrosine Kinase Inhibitor (TKI) Therapy

Cogent Biosciences, Inc.·interventional·Posted Mar 30, 2015·Updated Feb 14, 2025

In Brief

A Phase 2 clinical trial evaluating CGT9486, Pexidartinib, and 1 other intervention for Gastrointestinal Stromal Tumors. Completed, enrolled 51 participants across 6 sites.

Detailed Summary

The goal of this clinical research study is to learn how CGT9486 (fka PLX9486) may affect cancer cells with certain mutations in the KIT gene, specifically in participants with types of advanced solid tumors including gastrointestinal stromal tumor (GIST). CGT9486 (fka PLX9486) is designed to block KIT gene mutations. These mutations can cause cancer and cancer cell growth. By blocking these mutations, the drug may kill the cancer cells with the mutation and/or stop the tumor from growing. By combining CGT9486 (fka PLX9486) with PLX3397 and CGT9486 (fka PLX9486) with sunitinib, the investigators hope to block most KIT gene mutations that drive cancer growth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsPlexxikon

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 30, 2015
Enrollment StartMar 6, 2015
Primary CompletionMay 11, 2020
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 11.3 years ago

Interventions

CGT9486drug

CGT9486 will be administered per dose and schedule specified in the arm.

Pexidartinibdrug

Pexidartinib capsules will be administered per dose and schedule specified in the arm.

Sunitinibdrug

Sunitinib will be administered per dose and schedule specified in the arm.