Trials / Completed
CompletedNCT04254939
A Study of CS3007 in Subjects With Gastrointestinal Stromal Tumor
A Phase I/II Clinical Study of Avapritinib in Chinese Subjects With Unresectable or Metastatic Gastrointestinal Stromal Tumor
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 65 (actual)
- Sponsor
- CStone Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CS3007 (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. |
Timeline
- Start date
- 2019-08-15
- Primary completion
- 2020-04-30
- Completion
- 2023-04-11
- First posted
- 2020-02-05
- Last updated
- 2023-04-27
Locations
16 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04254939. Inclusion in this directory is not an endorsement.