Gastrointestinal Stromal Tumors
Conditions
Brief summary
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).
Interventions
DRUGCS3007 (BLU-285)
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.
Sponsors
Blueprint Medicines Corporation
CStone Pharmaceuticals
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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. 2. For phase II study: i) Group 1: Chinese subjects with unresectable GIST harboring D842V mutation in PDGFRα gene. ii) Group 2: Chinese third-line and fourth-line or later subjects with unresectable GIST that has progressed after standard treatment and/or do not tolerate standard treatment, and do not have a known D842V mutation in the PDGFRα gene. 3. Subjects with at least one measurable lesion as defined per mRECIST v1.1 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Exclusion criteria
1. Subject has any of the laboratory results that meet
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 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 |
| Phase II: ORR based on mRESIST 1.1 | 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 |
Countries
China
Outcome results
None listed