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Report for Clinical Trial NCT04254939

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase I/II Clinical Study of Avapritinib in Chinese Subjects With Unresectable or Metastatic Gastrointestinal Stromal Tumor

This study is an open-label, multicenter, phase I/II study to evaluate the safety, PK and clinical efficacy of avapritinib in Chinese subjects with unresectable or metastatic GIST. The study consists of two parts: dose escalation (phase I) and dose expansion (phase II).

NCT04254939 Gastrointestinal Stromal Tumors
MeSH:Gastrointestinal Stromal Tumors
HPO:Gastrointestinal stroma tumor

1 Interventions

Name: CS3007 (BLU-285)

Description: A modified "3+3" dose escalation design will be adopted. Each group will enroll 3-6 subjects. Avapritinib will be administered orally at the starting of 200 mg QD. A cycle consists of 28 consecutive days.
Type: Drug
Group Labels: 1


Primary Outcomes

Measure: Phase I: Recommended Phase II dose (RP2D), incidence of dose limiting toxicities (DLT) in Cycle 1, incidence and severity of adverse events and serious adverse events and changes in vital signs, clinical laboratory results and ECG findings

Time: at the end of Cycle 1 (each cycle is 28 days) for RP2D and DLT; during every cycle through 30 days after the last dose of study drug, an average of approximately 24 months, for other measures

Measure: Phase II: ORR based on mRESIST 1.1

Time: At Cycle 3 (each cycle is 28 days) Day 1, then every 2 cycles until Cycle 13, they every 3 cycles through study completion, disease progression or patient discontinuation from the study (whichever comes first), an average of approximately 24 months

Purpose: Treatment

Sequential Assignment

There are 2 SNPs


1 D824V

iii) Group 3: Chinese subjects with unresectable GIST that doesn't harbor D824V mutation in PDGFRα gene and that has progressed despite treatment with imatinib and at least another tyrosine kinase inhibitor. --- D824V ---

2 D842V

For phase I study, the subject must have histologically or cytologically confirmed unresectable or metastatic GIST that progressed after imatinib and at least one additional TKI treatment, or who cannot tolerate the standard treatment or have D842V mutation in the PDGFRα gene. --- D842V ---

2. For phase II study: i) Group 1: Chinese subjects with unresectable GIST harboring D842V mutation in PDGFRα gene. --- D842V ---

Patients must not have a known D842V mutation in PDGFRα gene. --- D842V ---

HPO Nodes