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Trial record 1 of 5 for:    dcc-2618, gist
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A Study of DCC-2618 (Ripretinib) Evaluating Efficacy, Safety, and Pharmacokinetics In Patients With Advanced Gastrointestinal Stromal Tumors (GIST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04282980
Recruitment Status : Recruiting
First Posted : February 25, 2020
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
Zai Lab (Shanghai) Co., Ltd.

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.This study will enroll approximately 35 subjects in up to 10 sites in China mainland, and all subjects will be receiving DCC-2618 after enrollment as treatment.

Condition or disease Intervention/treatment Phase
Gastrointestinal Stromal Tumors Drug: DCC-2618 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : April 23, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2022


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 Name: Ripretinib




Primary Outcome Measures :
  1. Progression-Free Survival(PFS) based on independent imaging review [ Time Frame: 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 :
  1. Objective Response Rate(ORR) based on independent imaging review [ Time Frame: 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.

  2. Overall survival (OS) [ Time Frame: 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.

  3. Time to Best Response(TBR) based on independent radiology review [ Time Frame: 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.

  4. Progression-Free Survival(PFS) assessment by investigators [ Time Frame: 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)

  5. Disease Control Rate(DCR) [ Time Frame: 12 Weeks ]
    Disease control will be defined as complete response or partial responses or stable disease.



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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04282980


Contacts
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Contact: Zai Lab +86 21 6163 2588 info@zailaboratory.com

Locations
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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China
Contact: Lin Shen         
Chinese People's Liberation Army General Hospital Recruiting
Beijing, Beijing, China
Contact: Xin Wu         
China, Chongqing
Union Medical College Hospital, Chongqing Medical University Recruiting
Chongqing, Chongqing, China
Contact: Jun Zhang         
China, Fujian
Union Medical College Hospital, Fujian Medical University Recruiting
Fuzhou, Fujian, China
Contact: Yongjian Zhou         
China, Guangdong
The First Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China
Contact: Shirong Cai         
The Sixth Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China
Contact: YanHong Deng         
China, Shanghai
Fudan University Cancer Hospital Recruiting
Shanghai, Shanghai, China
Contact: Ye Zhou         
Renji Hospital, Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, Shanghai, China
Contact: Hui Cao         
China, Sichuan
West China Hospital of Sichuan University Not yet recruiting
Chengdu, Sichuan, China
Contact: Bo Zhang         
Sponsors and Collaborators
Zai Lab (Shanghai) Co., Ltd.
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Responsible Party: Zai Lab (Shanghai) Co., Ltd.
ClinicalTrials.gov Identifier: NCT04282980    
Other Study ID Numbers: ZL-2307-002
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zai Lab (Shanghai) Co., Ltd.:
Gastrointestinal Stromal Tumors,GIST,DCC-2618,Ripretinib
Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors
Neoplasms
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases