US Cancer Center started a clinical trial of Avapritinib for the Treatment of CKIT or PDGFRA Mutation-Positive Locally Advanced or Metastatic Malignant Solid Tumors

M.D. Anderson Cancer Center is starting a new clinical trial of Avapritinib for the Treatment of CKIT or PDGFRA Mutation-Positive Locally Advanced or Metastatic Malignant Solid Tumors.

This phase II trial studies the effect of avapritinib in treating malignant solid tumors that have a genetic change (mutation) in CKIT or PDGFRA and have spread to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic). Avapritinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Avapritinib may help to control the growth of malignant solid tumors.

The clinical trial started in January 20, 2021 and will continue throughout July 1, 2022.

Among inclusion criteria are:

• The patient (or legally acceptable representative if applicable) provides written informed consent for the study.
• >= 18 years of age on the day of informed consent signing.
• Patient has a locally advanced or metastatic solid tumor and has progressed on appropriate standard therapy, has not shown clinically meaningful benefit to appropriate standard therapy, has no available standard therapy, or has declined appropriate standard therapy.
• Measurable disease per the RECIST v1.1 or Response Assessment in Neuro-Oncology Criteria (RANO) criteria, as appropriate (for Cohorts 1 and 2 only). NOTE: Patients in Cohort 3 can have measurable or non-measurable disease.
• Documented pathogenic CKIT activating mutation (Cohort 1) OR pathogenic PDGFRA activating mutation (Cohort 2) based on tissue-based next-generation sequencing (NGS) diagnostic test (Oncomine Comprehensive Assay [OCA] or FoundationOne CDx) OR plasma cfDNA-detected (Guardant360) pathogenic CKIT or PDGFRA activating mutation (for patients with measurable disease) or tissue or cfDNA-detected pathogenic CKIT or PDGFRA activating mutation (for patients with non-measurable disease; Cohort 3). Mutation pathogenicity will be verified by the MD Anderson Cancer Center (MDACC) Precision Oncology Decision Support (PODS) team.
• Has available archival tissue for CKIT or PDGFRA mutation testing.
• Lymphocyte count >= 500/uL (within 28 days of study treatment initiation)

The full list can be viewed at the link below.

The contacts and locations are the M D Anderson Cancer Center, Houston, Texas, United States. For more details: https://ichgcp.net/clinical-trials-registry/NCT04771520