Spots Global Cancer Trial Database for A Study of DCC-2618 (Ripretinib) In Patients With With Advanced Gastrointestinal Stromal Tumors (GIST)
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Trial Identification
Brief Title: A Study of DCC-2618 (Ripretinib) In Patients With With Advanced Gastrointestinal Stromal Tumors (GIST)
Official Title: A Multicenter Phase 2, Single-Arm Open-Label Study of DCC-2618 to Assess Efficacy, Safety, and Pharmacokinetics In Patients With Advanced Gastrointestinal Stromal Tumors Who Have Progressed On Prior Anticancer Therapies.
Study ID: NCT04282980
Conditions
Interventions
Study Description
Brief Summary: The primary objective of this trial is to evaluate the progress free survival (PFS) of DCC-2618 in patients with advanced gastrointestinal stromal tumors who have progressed with prior anticancer therapies based on independent radiologic review.
Detailed Description: The primary objective of this trial is to evaluate the progress free survival (PFS) of DCC-2618 in patients with advanced gastrointestinal stromal tumors who have progressed with prior anticancer therapies based on independent radiologic review. This study enrolled 39 subjects of 9 sites in China mainland, and all enrolled subjects received DCC-2618 after enrollment as treatment. The study used EDC to collect patient data and IRT system for patient randomization, using Imaging Endpoints as the central image to evaluate the PFS.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Beijing Cancer Hospital, Beijing, Beijing, China
Chinese People's Liberation Army General Hospital, Beijing, Beijing, China
Union Medical College Hospital, Chongqing Medical University, Chongqing, Chongqing, China
Union Medical College Hospital, Fujian Medical University, Fuzhou, Fujian, China
The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
Fudan University Cancer Hospital, Shanghai, Shanghai, China
Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai, China
West China Hospital of Sichuan University, Chengdu, Sichuan, China
Contact Details
Name: Zai Lab
Affiliation: Zai Lab (Shanghai) Co., Limited
Role: STUDY_DIRECTOR
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