Expanded Access to Bezuclastinib to be Coadministered With Sunitinib for Patients With Gastrointestinal Stromal Tumors
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age18+
SponsorCogent Biosciences, Inc.
About this trial
The purpose of this expanded access program (EAP) is to provide investigational bezuclastinib so that it can be coadministered with sunitinib to patients with a diagnosis of gastrointestinal stromal tumors (GIST) with no comparable or satisfactory alternative therapy options. The combination of bezuclastinib and sunitinib provides broad inhibition of all primary and secondary KIT mutations that commonly occur in GIST.
Eligibility criteria
Qualifiers
Able to provide written informed consent and commit to recommended EAP assessments.
≥18 years of age.
Able to swallow tablets.
Histologically confirmed locally advanced, metastatic, and/or unresectable GIST.
Disqualifiers
Patients who are eligible for and capable of participating in and/or enrolled in an on-going bezuclastinib clinical trial.
Prior or known intolerance to sunitinib.
Patients who have previously participated in a bezuclastinib clinical trial.
Patients with persistent > Grade 2 toxicities from prior therapy.
Trial design
Treatments tested in this trial
- Bezuclastinib
- Sunitinib
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov