Article written by one of our Melanoma/Sarcoma Clinical Trial Coordinators Chloe Caldwell to a target audience of healthcare providers regarding a new ongoing protocol for patients dealing with GIST open globally and at the Orlando Health Cancer Institute. All information posted here is publicly available here.
Gastrointestinal Stromal Tumors (GIST) constitute a category of soft tissue sarcoma primarily affecting adults, noted for their presence throughout the gastrointestinal (GI) tract. Despite its rarity in comparison to other soft tissue sarcomas, the medical community continues to explore this type of tumor diligently.
For metastatic or recurrent GIST, inoperable by surgical means, the standard protocol involves targeted therapy. First-line treatment often incorporates a drug known as Imatinib. Imatinib (Gleevec) is a TKI (tyrosine kinase inhibitor) targeting the tyrosine kinase protein involved in cellular growth. The anticipated effect of this inhibition is either cancer regression or stabilization.
Should disease progression occur or the side effects of Gleevec become intolerable, Sunitinib (SUTENT) typically becomes the next therapeutic option. As a TKI, similar to Imatinib, Sunitinib not only offers effectiveness in treating specific cancers, but it also curbs the growth of blood vessels, a requirement for tumor growth.
With the landscape of cancer treatment ever-evolving, it is important to note, as per a 2020 presentation by Cogent Biosciences, that about 60% of GIST patients develop resistance to Imatinib, rendering the drug inefficient. Thus, anticipating the next course of action when the initial plan falls short is crucial.
This need underscores the importance of clinical trials.
Cogent Biosciences has embarked on a Phase 3 clinical trial, segregated into three sections (1a, 1b, and 2). The trial pertains to the oral administration of CGT9486 (Bezuclastinib), either standalone or in conjunction with Sunitinib for GIST treatment. CGT9486 is a TKI designed to target more specific mutations present in cancer cell genes. Currently, the trial is recruiting patients for part 2, with a focus on those who exhibited a suboptimal response to Imatinib.
The combination therapy’s safety and effectiveness profile, at this juncture, appears promising. Although the clinical trial is still underway, it offers hope for more potent and lasting treatment options than ever before.
Those interested in participating in the study can find the inclusion/exclusion criteria and the list of cancer centers offering the trial at clinicaltrials.gov and at the Orlando Health Cancer Institute.