- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04633122
A Study to Assess the Efficacy and Safety of DCC-2618 and Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumors After Treatment With Imatinib
March 17, 2023 updated by: Zai Lab (Shanghai) Co., Ltd.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
108
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China
- Beijing Cancer Hospital
-
Beijing, Beijing, China
- Chinese PLA General Hospital
-
Beijing, Beijing, China
- The General Hospital of Peking University
-
-
Chognqing
-
Chongqing, Chognqing, China
- The First Affiliated Hospital of Chongqing Medical Universty
-
-
Fujian
-
Fuzhou, Fujian, China
- Fujian Medical University Union Hospital
-
-
Guangdong
-
Guangzhou, Guangdong, China
- The First Affiliated Hospital of Sun Yat-Sen University
-
Guangzhou, Guangdong, China
- The Cancer Hospital of Sun Yat-sen University
-
Guangzhou, Guangdong, China
- The Sixth Affiliated Hospital of Sun Yat-sen University
-
-
Hebei
-
Shijiazhuang, Hebei, China
- The 4th Hospital of Hebei Medical University
-
-
Heilongjiang
-
Ha'erbin, Heilongjiang, China
- The Affiliated Hospital of Haerbin MedicalUniversity
-
-
Hubei
-
Wuhan, Hubei, China
- Union Hospital of HUST
-
-
Shandong
-
Qingdao, Shandong, China
- The Affiliated Hospital of Qingdao University
-
-
Shanghai
-
Shanghai, Shanghai, China
- Renji Hospital, Shanghai Jiaotong University School of Medicine
-
Shanghai, Shanghai, China
- Fudan University Cancer Hospital
-
Shanghai, Shanghai, China
- Fudan University, Zhongshan Hospital
-
-
Sichuan
-
Chengdu, Sichuan, China
- West China Hospital of Sichuan University
-
-
Xinjiang
-
Ürümqi, Xinjiang, China
- The Affiliated Hospital of Xinjiang Medical University
-
-
Zhejiang
-
Hangzhou, Zhejiang, China
- Zhejiang Cancer Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female patients ≥18 years of age.
- Histological diagnosis of advanced GIST and capability of providing tumor tissue sample (the interval between tumor tissue collection and signing of informed consent form should be less than 3 years). Otherwise, biopsy is required.
- Provide molecular test report with KIT/PDGFRA mutation status prior to randomization.
- Patients must have progressed on imatinib or have documented intolerance to imatinib. Subjects must have discontinued imatinib treatment 10 days prior to the first dose of the study drug. All prior imatinib treatments will be considered as first-line (such as imatinib adjuvant therapy and imatinib dose increase).
- ECOG PS of 0-2.
- Female patients of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) pregnancy test at screening.
- Patients of reproductive potential must agree to follow the contraception requirements.
- At least 1 measurable lesion according to the "RECIST v1.1-GIST-specific Criteria" (non-nodal lesions must be ≥1.0 cm in the long axis or ≥ double the slide thickness in the long axis) ; obtaining radiographic image results within 28 days prior to the first dose of study drug.
Good organ function and bone marrow reserve function, including:
- Neutrophil count ≥ 1,000/µL
- Hemoglobin ≥ 8 g/dL
- Platelet count ≥ 75,000/µL
- Total bilirubin ≤ 1.5 × the upper limit of normal (ULN)
- AST and ALT ≤ 3×ULN, and AST and ALT≤ 5×ULN in the presence of hepatic metastases
- Creatinine clearance ≥ 50 mL/min (based on Cockcroft-Gault estimation Formulas for calculation)
- Prothrombin time (PT), international normalized ratio (INR) or partial thromboplastin time ≤ 1.5 × ULN. Patients on a stable, maintenance regimen of anticoagulant therapy for at least 30 days prior to study drug administration may have PT/INR measurements >1.5 × ULN if, in the opinion of the investigator, the patient is suitable for the study. An adequate rationale must be provided to the sponsor prior to randomization.
- Resolution of all toxicities from prior therapy to ≤Grade 1 (or baseline) within 1 week prior to the first dose of study drug (excluding alopecia and ≤ Grade 3 clinically asymptomatic lipase, amylase, and creatine phosphokinase laboratory abnormalities).
- Patient is capable of understanding and complying with the protocol. Subjects should sign the written informed consent before any study-related procedures were performed.
Exclusion Criteria:
- Treatment with any other line of therapy in addition to imatinib for advanced GIST. Imatinib-containing combination therapy in the first-line treatment should not be enrolled.
- Patients with a prior or concurrent malignancy whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of this clinical trial are not eligible.
- Patient has known active central nervous system metastases.
- New York Heart Association class II - IV heart disease, myocardial infarct, active ischemia or any other uncontrolled cardiac condition within the first 6 months of the first dose of study drug such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure.
- Left ventricular ejection fraction (LVEF) < 50%.
- Arterial thrombotic or embolic events such as cerebrovascular accident (including ischemic attacks) or hemoptysis within 6 months before the first dose of study drug.
- Venous thrombotic events (e.g. deep vein thrombosis) or pulmonary arterial events (e.g. pulmonary embolism) within 1 month before the first dose of study drug. Patients on stable anticoagulation therapy for at least one month are eligible.
- 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.
- Use of strong or moderate inhibitors and/or inducers of cytochrome P450 (CYP) 3A4 within 14 days or 5 x the half-life (whichever is longer) prior to the first dose of study drug, including certain herbal medications (eg, St. John's Wort) and consumption of grapefruit or grapefruit juice within 14 days prior to the first dose of study drug.
- 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 study drug.
- Major surgeries (e.g. abdominal laparotomy) within 4 weeks of the first dose of study drug; all major surgical wounds must be healed and free of infection or dehiscence before the first dose of study drug.
- Any other clinically significant comorbidities, such as uncontrolled pulmonary disease, active infection, or any other condition, 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.
- Known human immunodeficiency virus or hepatitis C infection only if the patient is taking medications that are excluded per protocol, hepatitis B virus (HBV) DNA > 2000 IU/ml or > 104 copies/ml.
- Female patients who are pregnant or lactating or who plan to become pregnant during the study treatment period.
- Known hypersensitivity to any component of the study drug. Patients with Stevenson Johnson syndrome in previous TKI treatment need to be excluded.
Gastrointestinal abnormalities including but not limited to:
- inability to take oral medication
- malabsorption syndrome
- Requiring intravenous nutrition
- Any active hemorrhages, excluding hemorrhoids or gum bleeding.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ripretinib
50mg/tablet,150 mg QD continuous administration, 6 weeks (42 days) for a cycle.
|
Oral kinase inhibitor
Other Names:
|
Active Comparator: Sunitinib
12.5mg/capsule, 50 mg QD, in 6 weeks (42 days) with 4 weeks continuous dosing followed by 2 weeks break.
|
second-line therapy in GIST patients who have progressed after imatinib treatment or are intolerant to imatinib
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
7 months after enrollment is completed in study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
objective response rate(ORR)
Time Frame: 7 months after enrollment is completed in study
|
To assess objective response rate (ORR) by independent radiologic review using RECIST v1.1-GIST-specific criteria
|
7 months after enrollment is completed in study
|
DCR
Time Frame: 7 months after enrollment is completed in study
|
To assess disease control rate (DCR) by independent radiologic review
|
7 months after enrollment is completed in study
|
PFS assessed by investigator
Time Frame: 7 months after enrollment is completed in study
|
To assess PFS based on Investigator assessment
|
7 months after enrollment is completed in study
|
overall survival (OS)
Time Frame: 7 months after enrollment is completed in study
|
To assess overall survival (OS)
|
7 months after enrollment is completed in study
|
To compare the safety profile of DCC-2618 (ripretinib, ZL-2307) to the safety profile of sunitinib by using AE/SAE/AESI collection during study.
Time Frame: 7 months after enrollment is completed in study
|
|
7 months after enrollment is completed in study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 25, 2020
Primary Completion (Actual)
July 20, 2022
Study Completion (Actual)
July 20, 2022
Study Registration Dates
First Submitted
November 11, 2020
First Submitted That Met QC Criteria
November 16, 2020
First Posted (Actual)
November 18, 2020
Study Record Updates
Last Update Posted (Actual)
March 20, 2023
Last Update Submitted That Met QC Criteria
March 17, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Neoplasms, Connective Tissue
- Gastrointestinal Stromal Tumors
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Sunitinib
Other Study ID Numbers
- ZL-2307-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gastrointestinal Stromal Tumor(GIST)
-
Centre Leon BerardRecruitingMetastatic Gastrointestinal Stromal Tumor | Unresectable Gastrointestinal Stromal Tumor (GIST) | Locally Advanced Gastrointestinal Stromal Tumor (GIST)France
-
Centre Leon BerardRecruitingC-KIT Mutation | Metastatic Gastrointestinal Stromal Tumor (GIST) | Advanced Gastrointestinal Stromal Tumor (GIST)France
-
Hospital Universitario Virgen de la ArrixacaNot yet recruitingLiver Diseases | Liver Transplantation | Liver Neoplasms | Gastrointestinal Stromal Tumors | Metastasis | Liver Metastases | Liver Transplant; Complications | Liver Cancer | Liver Transplant Disorder | Liver Carcinoma | GIST, Malignant | GIST | Metastases | Metastatic Liver Cancer | Gastrointestinal Stromal Tumor of... and other conditionsSpain
-
Ascentage Pharma Group Inc.HealthQuest Pharma Inc.RecruitingSolid Tumor, Adult | Gastrointestinal Stromal Tumor (GIST)China
-
National Health Research Institutes, TaiwanNational Taiwan University Hospital; Mackay Memorial Hospital; China Medical... and other collaboratorsRecruitingGastrointestinal Stromal Tumor (GIST)Taiwan
-
Kristen GanjooGlaxoSmithKlineTerminatedGastrointestinal Stromal Tumor (GIST)United States
-
Instituto Ecuatoriano de Enfermedades DigestivasRecruitingGastrointestinal Stromal Tumor (GIST)Ecuador
-
Sichuan Provincial People's HospitalRecruitingGastrointestinal Stromal Tumor(GIST)China
-
Memorial Sloan Kettering Cancer CenterActive, not recruitingGastrointestinal Stromal Tumor (GIST)United States
-
Memorial Sloan Kettering Cancer CenterPlexxikon; Array BioPharmaCompletedGastrointestinal Stromal Tumor (GIST)United States
Clinical Trials on Ripretinib
-
Peking UniversityThe First Affiliated Hospital with Nanjing Medical University; Xiangya Hospital... and other collaboratorsActive, not recruitingGastrointestinal Stromal TumorsChina
-
Zai Lab (Shanghai) Co., Ltd.CompletedGastrointestinal Stromal TumorsChina
-
Deciphera Pharmaceuticals LLCCompletedGastrointestinal Stromal Tumors | Advanced Cancers | Advanced Systemic MastocytosisUnited States, Canada, Germany, Italy, Netherlands, United Kingdom
-
Deciphera Pharmaceuticals LLCApproved for marketingGIST - Gastrointestinal Stromal Tumor
-
Deciphera Pharmaceuticals LLCCompletedGastrointestinal Stromal TumorsUnited States, France, Finland, United Kingdom, Germany, Netherlands, Italy, Belgium, Spain, Canada, Australia, Poland, Singapore
-
RenJi HospitalRecruitingGastrointestinal Stromal TumorsChina
-
Deciphera Pharmaceuticals LLCWithdrawnGastrointestinal Stromal Tumors
-
Deciphera Pharmaceuticals LLCActive, not recruitingGIST - Gastrointestinal Stromal TumorUnited States
-
Deciphera Pharmaceuticals LLCPfizerRecruitingColorectal Cancer | GISTUnited States
-
Deciphera Pharmaceuticals LLCRecruitingGISTUnited States, Korea, Republic of, Spain, Taiwan, Australia, Canada, United Kingdom, Italy, Netherlands, Brazil, Chile, Poland