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Report for Clinical Trial NCT04254939
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
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).
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.
Group Labels: 1 CS3007(BLU-285)
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
There are 2 SNPs
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 ---
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 ---