At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 65 enrolled
Drug / intervention
CS3007 (BLU-285)drug
Likely dose
CS3007 (BLU-285) 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II Clinical Study of Avapritinib in Chinese Subjects With Unresectable or Metastatic Gastrointestinal Stromal Tumor
In Brief
A Phase 2 clinical trial evaluating CS3007 (BLU-285) for Gastrointestinal Stromal Tumors. Completed, enrolled 65 participants across 16 sites.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastrointestinal Stromal Tumors
CountriesChina
CollaboratorsBlueprint Medicines Corporation
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
Enrollment StartAug 2019
First PostedFeb 2020
Primary CompletionApr 2020
Study CompletionApr 2023
TodayJul 2026
First PostedFeb 5, 2020
Enrollment StartAug 15, 2019
Primary CompletionApr 30, 2020
Study CompletionApr 11, 2023
TodayJul 1, 2026
Enrollment to primary: 9 monthsPosted 6.4 years ago
Interventions
CS3007 (BLU-285)drug
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.