A Study to Assess the Efficacy and Safety of DCC-2618 and Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumors After Treatment With Imatinib
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ClinicalTrials.gov Identifier: NCT04633122 |
Recruitment Status :
Completed
First Posted : November 18, 2020
Last Update Posted : March 20, 2023
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Sponsor:
Zai Lab (Shanghai) Co., Ltd.
Information provided by (Responsible Party):
Zai Lab (Hong Kong), Ltd. ( Zai Lab (Shanghai) Co., Ltd. )
Tracking Information | |||||
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First Submitted Date ICMJE | November 11, 2020 | ||||
First Posted Date ICMJE | November 18, 2020 | ||||
Last Update Posted Date | March 20, 2023 | ||||
Actual Study Start Date ICMJE | November 25, 2020 | ||||
Actual Primary Completion Date | July 20, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
PFS assessed by independent central review [ Time Frame: 7 months after enrollment is completed in study ] To assess the efficacy (progression-free survival [PFS], by independent radiologic review)of DCC-2618 (ripretinib, ZL-2307) and sunitinib in patients
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study to Assess the Efficacy and Safety of DCC-2618 and Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumors After Treatment With Imatinib | ||||
Official Title ICMJE | 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 | ||||
Brief Summary | the primary objective of this study is to assess the efficacy (progression-free survival,PFS) of DCC-2618 (ripretinib, ZL-2307) and sunitinib in patients with advanced gastrointestinal stromal tumors after treatment with imatinib. This study will enroll approximately 98 subjects in around 18 sites in China mainland, and all subjects will be receiving DCC-2618 or Sunitinib in equal chance as treatment. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Gastrointestinal Stromal Tumor(GIST) | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
108 | ||||
Original Estimated Enrollment ICMJE |
98 | ||||
Actual Study Completion Date ICMJE | July 20, 2022 | ||||
Actual Primary Completion Date | July 20, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04633122 | ||||
Other Study ID Numbers ICMJE | ZL-2307-003 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Zai Lab (Hong Kong), Ltd. ( Zai Lab (Shanghai) Co., Ltd. ) | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Zai Lab (Shanghai) Co., Ltd. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Zai Lab (Hong Kong), Ltd. | ||||
Verification Date | March 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |