A Study of CS3007 in Subjects With Gastrointestinal Stromal Tumor
- Conditions
- Gastrointestinal Stromal Tumors
- Interventions
- Drug: CS3007 (BLU-285)
- Registration Number
- NCT04254939
- Lead Sponsor
- CStone Pharmaceuticals
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description CS3007(BLU-285) CS3007 (BLU-285) -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (16)
The First Affiliated Hospital of Nanchang Medical University
🇨🇳Nanchang, Jiangxi, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Wuhan Union Hospital Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
The First Affiliated Hospital of Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
The Sixth Affiliated Hospital of Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China
Fudan University Zhongshan Hospital (General Surgery Department)
🇨🇳Shanghai, Shanghai, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
Liaoning Cancer Hospital & Institute
🇨🇳Shenyang, Liaoning, China
Fudan University Zhongshan Hospital (Internal Tumor Department)
🇨🇳Shanghai, Shanghai, China
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Xinjiang Medical University Cancer Hospital
🇨🇳Urumqi, Xinjiang, China
The First Affiliated Hospital Zhe Jiang University
🇨🇳Hangzhou, Zhejiang, China