SNPMiner Trials by Shray Alag


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Report for Mutation A864V

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

There is one clinical trial.

Clinical Trials


1 A Phase 2 Study of Poziotinib in Patients With EGFR or HER2 Activating Mutations in Advanced Malignancies

This is a Phase 2, open-label, multicenter study to evaluate the efficacy and the safety/tolerability of poziotinib in five patient cohorts for up to 150 previously treated patients with any systemic therapy (Cohort 1: 30 Patients that have HER2-positive or HER2-negative breast cancer with HER2 activating mutations, Cohort 2: 30 Patients that have colorectal cancer with HER2 activating mutations, Cohort 3: Patients that have solid tumors (except NSCLC, breast cancer, or colorectal cancer) with HER2 activating mutations, Cohort 4: 30 Patients that have high-grade glioma with EGFR activating mutations, and Cohort 5: 30 Patients that have solid tumors (except NSCLC or high-grade glioma) with EGFR activating mutations.

NCT04172597 Breast Cancer Colorectal Cancer Solid Tumor High Grade Glioma Drug: Poziotinib Hydrochloride
MeSH:Breast Neoplasms
HPO:Breast carcinoma Neoplasm of the breast

EGFR Activating Mutations (at least one of the following) Extracellular & Transmembrane: EGFRvIII, R108K, R222C, A289T, P596L, G598V Kinase Domain: Exon 20 insertion, E709K, G719X, V742I, E746_A750del, S768I, V769M, V774M, R831C, R831H, L858R, L861Q, A864V 5. Patient has measurable disease, as per the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) and/or RANO Criteria for Cohort 4. These target lesion(s) must be radiographically measurable. --- R108K --- --- R222C --- --- A289T --- --- P596L --- --- G598V --- --- E709K --- --- V742I --- --- S768I --- --- V769M --- --- V774M --- --- R831C --- --- R831H --- --- L858R --- --- L861Q --- --- A864V ---

Primary Outcomes

Description: Proportion of patients whose best overall response is confirmed CR or PR

Measure: Objective Response Rate (ORR)

Time: 24 months

Secondary Outcomes

Description: Time from the first CR or PR until progressive disease or death

Measure: Duration of Response (DoR)

Time: 24 months

Description: Proportion of patients whose best overall response is CR, PR, or SD

Measure: Disease Control Rate (DCR)

Time: 24 months


HPO Nodes