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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.

Tracking Information
First Submitted Date  ICMJE February 21, 2020
First Posted Date  ICMJE February 25, 2020
Last Update Posted Date July 1, 2020
Actual Study Start Date  ICMJE April 23, 2020
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2020)
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) .
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2020)
  • 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.
  • 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.
  • 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.
  • 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)
  • Disease Control Rate(DCR) [ Time Frame: 12 Weeks ]
    Disease control will be defined as complete response or partial responses or stable disease.
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 of DCC-2618 (Ripretinib) Evaluating Efficacy, Safety, and Pharmacokinetics In Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
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 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastrointestinal Stromal Tumors
Intervention  ICMJE Drug: DCC-2618
Oral kinase inhibitor
Other Name: Ripretinib
Study Arms  ICMJE Experimental: DCC-2618
DCC-2618 drug is 50mg per tablet, 150mg once a day, with 28 days as a treatment cycle.
Intervention: Drug: DCC-2618
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 21, 2020)
35
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Zai Lab +86 21 6163 2588 info@zailaboratory.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04282980
Other Study ID Numbers  ICMJE ZL-2307-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zai Lab (Shanghai) Co., Ltd.
Study Sponsor  ICMJE Zai Lab (Shanghai) Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Zai Lab (Shanghai) Co., Ltd.
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP