Back to resultsA Study of DCC-2618 (Ripretinib) In Patients With With Advanced Gastrointestinal Stromal Tumors (GIST)
Primary Purpose
Gastrointestinal Stromal Tumors
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
DCC-2618
Sponsored by
About this trial
This is an interventional treatment trial for Gastrointestinal Stromal Tumors focused on measuring Gastrointestinal Stromal Tumors,GIST,DCC-2618,Ripretinib
Eligibility Criteria
Inclusion Criteria:
- Male or female patients ≥18 years of age.
- Patients with advanced gastrointestinal stromal tumors.
- Subjects who have progressed or documented intolerance after previous treatments.
- Sign informed consent, understand the Protocol and could follow the Protocol.
- The subject had at least one measurable lesion.
- Adequate organ function and bone marrow reserve
Exclusion Criteria:
- Treatment with anticancer therapy, including investigational therapy, or investigational procedures within 14 days or 5 x the half-life (whichever is longer) prior to the first dose of investigational drug.
- Prior treatment with DCC-2618.
- Previously or currently has an additional malignancy that is progressing or required active treatment, which may interfere with the safety or efficacy evaluation of DCC-2618.
- Patient has known active central nervous system metastases.
- New York Heart Association class II - IV heart disease, active ischemia or any other uncontrolled cardiac condition.
- Arterial thrombotic or embolic events within 6 months before the first dose of investigational drug.
- Venous thrombotic events within 3 months before the first dose of investigational drug.
- 12-lead electrocardiogram (ECG) demonstrating QT interval corrected by Fridericia's formula >450 ms in males or >470 ms in females at screening or history of long QT interval syndrome.
- Left ventricular ejection fraction (LVEF) <50% at screening.
- Use of known substrates or inhibitors of breast cancer resistance protein (BCRP) transporters within 14 days or 5 x the half-life (whichever is longer) prior to the first dose of investigational drug.
- Major surgeries within 4 weeks of the first dose of investigational drug.
- Any other clinically significant comorbidities, which in the judgment of the investigator, could compromise compliance with the protocol, interfere with interpretation of the study results, or predispose the patient to safety risks.
- Active viral infections.
- If female, the patient is pregnant or lactating, or plans to become pregnant during the study treatment period.
- Known allergy or hypersensitivity to any component of the investigational drug.
- Gastrointestinal abnormalities.
- Any active hemorrhages, excluding hemorrhoids or gum bleeding.
Sites / Locations
- Beijing Cancer Hospital
- Chinese People's Liberation Army General Hospital
- Union Medical College Hospital, Chongqing Medical University
- Union Medical College Hospital, Fujian Medical University
- The First Affiliated Hospital of Sun Yat-sen University
- The Sixth Affiliated Hospital of Sun Yat-sen University
- Fudan University Cancer Hospital
- Renji Hospital, Shanghai Jiaotong University School of Medicine
- West China Hospital of Sichuan University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DCC-2618
Arm Description
DCC-2618 drug is 50mg per tablet, 150mg once a day, with 28 days as a treatment cycle.
Outcomes
Primary Outcome Measures
Progression-Free Survival(PFS) based on independent imaging review
Progression-Free Survival(PFS) is defined as the time from the first dose of study drug to the first documentation of disease progression based on independent radiology review or death due to any cause (whichever occurred first) .
Secondary Outcome Measures
Objective Response Rate(ORR) based on independent imaging review
Objective Response Rate(ORR) which is defined as the percentage of patients whose efficacy is confirmed as complete response(CR) or partial responses(PR) based on independent radiology review.
Overall survival (OS)
Overall survival (OS) is defined as the time from the first dose of study drug to all-cause death.
Time to Best Response(TBR) based on independent radiology review
Time to Best Response(TBR) based on independent radiology review is defined as the duration from the date of the first dose of the investigational drug to the date of confirming the best response.
Progression-Free Survival(PFS) assessment by investigators
Progression-Free Survival(PFS) assessed by investigators is defined as the duration from the first dose of study drug to the first documentation of disease progression by the investigator or all-cause death (whichever occurs first)
Disease Control Rate(DCR)
Disease control will be defined as complete response or partial responses or stable disease.
Full Information
NCT ID
NCT04282980
First Posted
February 21, 2020
Last Updated
August 26, 2022
Sponsor
Zai Lab (Shanghai) Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04282980
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 Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 23, 2020 (Actual)
Primary Completion Date
February 26, 2021 (Actual)
Study Completion Date
August 23, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zai Lab (Shanghai) Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Stromal Tumors
Keywords
Gastrointestinal Stromal Tumors,GIST,DCC-2618,Ripretinib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DCC-2618
Arm Type
Experimental
Arm Description
DCC-2618 drug is 50mg per tablet, 150mg once a day, with 28 days as a treatment cycle.
Intervention Type
Drug
Intervention Name(s)
DCC-2618
Other Intervention Name(s)
Ripretinib
Intervention Description
Oral kinase inhibitor
Primary Outcome Measure Information:
Title
Progression-Free Survival(PFS) based on independent imaging review
Description
Progression-Free Survival(PFS) is defined as the time from the first dose of study drug to the first documentation of disease progression based on independent radiology review or death due to any cause (whichever occurred first) .
Time Frame
Approximately 24 months since the first subject enrolled
Secondary Outcome Measure Information:
Title
Objective Response Rate(ORR) based on independent imaging review
Description
Objective Response Rate(ORR) which is defined as the percentage of patients whose efficacy is confirmed as complete response(CR) or partial responses(PR) based on independent radiology review.
Time Frame
Approximately 24 months since the first subject enrolled
Title
Overall survival (OS)
Description
Overall survival (OS) is defined as the time from the first dose of study drug to all-cause death.
Time Frame
Approximately 24 months since the first subject enrolled
Title
Time to Best Response(TBR) based on independent radiology review
Description
Time to Best Response(TBR) based on independent radiology review is defined as the duration from the date of the first dose of the investigational drug to the date of confirming the best response.
Time Frame
Approximately 24 months since the first subject enrolled
Title
Progression-Free Survival(PFS) assessment by investigators
Description
Progression-Free Survival(PFS) assessed by investigators is defined as the duration from the first dose of study drug to the first documentation of disease progression by the investigator or all-cause death (whichever occurs first)
Time Frame
Approximately 24 months since the first subject enrolled
Title
Disease Control Rate(DCR)
Description
Disease control will be defined as complete response or partial responses or stable disease.
Time Frame
12 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients ≥18 years of age.
Patients with advanced gastrointestinal stromal tumors.
Subjects who have progressed or documented intolerance after previous treatments.
Sign informed consent, understand the Protocol and could follow the Protocol.
The subject had at least one measurable lesion.
Adequate organ function and bone marrow reserve
Exclusion Criteria:
Treatment with anticancer therapy, including investigational therapy, or investigational procedures within 14 days or 5 x the half-life (whichever is longer) prior to the first dose of investigational drug.
Prior treatment with DCC-2618.
Previously or currently has an additional malignancy that is progressing or required active treatment, which may interfere with the safety or efficacy evaluation of DCC-2618.
Patient has known active central nervous system metastases.
New York Heart Association class II - IV heart disease, active ischemia or any other uncontrolled cardiac condition.
Arterial thrombotic or embolic events within 6 months before the first dose of investigational drug.
Venous thrombotic events within 3 months before the first dose of investigational drug.
12-lead electrocardiogram (ECG) demonstrating QT interval corrected by Fridericia's formula >450 ms in males or >470 ms in females at screening or history of long QT interval syndrome.
Left ventricular ejection fraction (LVEF) <50% at screening.
Use of known substrates or inhibitors of breast cancer resistance protein (BCRP) transporters within 14 days or 5 x the half-life (whichever is longer) prior to the first dose of investigational drug.
Major surgeries within 4 weeks of the first dose of investigational drug.
Any other clinically significant comorbidities, which in the judgment of the investigator, could compromise compliance with the protocol, interfere with interpretation of the study results, or predispose the patient to safety risks.
Active viral infections.
If female, the patient is pregnant or lactating, or plans to become pregnant during the study treatment period.
Known allergy or hypersensitivity to any component of the investigational drug.
Gastrointestinal abnormalities.
Any active hemorrhages, excluding hemorrhoids or gum bleeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zai Lab
Organizational Affiliation
Zai Lab (Shanghai) Co., Limited
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Chinese People's Liberation Army General Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Union Medical College Hospital, Chongqing Medical University
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
Union Medical College Hospital, Fujian Medical University
City
Fuzhou
State/Province
Fujian
Country
China
Facility Name
The First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
The Sixth Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Fudan University Cancer Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Renji Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study of DCC-2618 (Ripretinib) In Patients With With Advanced Gastrointestinal Stromal Tumors (GIST)
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