A Study of DCC-2618 (Ripretinib) In Patients With With Advanced Gastrointestinal Stromal Tumors (GIST)
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: DCC-2618 DCC-2618 drug is 50mg per tablet, 150mg once a day, with 28 days as a treatment cycle. |
Drug: DCC-2618
Oral kinase inhibitor
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Progression-Free Survival(PFS) based on independent imaging review [Approximately 24 months since the first subject enrolled]
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 [Approximately 24 months since the first subject enrolled]
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) [Approximately 24 months since the first subject enrolled]
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 [Approximately 24 months since the first subject enrolled]
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 [Approximately 24 months since the first subject enrolled]
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) [12 Weeks]
Disease control will be defined as complete response or partial responses or stable disease.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female patients ≥18 years of age.
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Patients with advanced gastrointestinal stromal tumors.
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Subjects who have progressed or documented intolerance after previous treatments.
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Sign informed consent, understand the Protocol and could follow the Protocol.
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The subject had at least one measurable lesion.
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Adequate organ function and bone marrow reserve
Exclusion Criteria:
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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.
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Prior treatment with DCC-2618.
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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.
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Patient has known active central nervous system metastases.
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New York Heart Association class II - IV heart disease, active ischemia or any other uncontrolled cardiac condition.
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Arterial thrombotic or embolic events within 6 months before the first dose of investigational drug.
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Venous thrombotic events within 3 months before the first dose of investigational drug.
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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.
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Left ventricular ejection fraction (LVEF) <50% at screening.
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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.
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Major surgeries within 4 weeks of the first dose of investigational drug.
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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.
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Active viral infections.
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If female, the patient is pregnant or lactating, or plans to become pregnant during the study treatment period.
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Known allergy or hypersensitivity to any component of the investigational drug.
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Gastrointestinal abnormalities.
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Any active hemorrhages, excluding hemorrhoids or gum bleeding.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Cancer Hospital | Beijing | Beijing | China | |
| 2 | Chinese People's Liberation Army General Hospital | Beijing | Beijing | China | |
| 3 | Union Medical College Hospital, Chongqing Medical University | Chongqing | Chongqing | China | |
| 4 | Union Medical College Hospital, Fujian Medical University | Fuzhou | Fujian | China | |
| 5 | The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | China | |
| 6 | The Sixth Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | China | |
| 7 | Fudan University Cancer Hospital | Shanghai | Shanghai | China | |
| 8 | Renji Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai | China | |
| 9 | West China Hospital of Sichuan University | Chengdu | Sichuan | China |
Sponsors and Collaborators
- Zai Lab (Shanghai) Co., Ltd.
Investigators
- Study Director: Zai Lab, Zai Lab (Shanghai) Co., Limited
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ZL-2307-002