A Study of DCC-2618 (Ripretinib) Evaluating Efficacy Safety and Pharmacokinetics In Patients With Advanced Gastrointestinal Stromal Tumors (GIST)

  • STATUS
    Recruiting
  • participants needed
    35
  • sponsor
    Zai Lab (Shanghai) Co., Ltd.
Updated on 19 February 2024
measurable disease
gastrointestinal stromal tumor
stromal tumor
ripretinib
dcc-2618

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.

Details
Condition gastrointestinal stromal tumor
Age 18years - 100years
Treatment DCC-2618
Clinical Study IdentifierNCT04282980
SponsorZai Lab (Shanghai) Co., Ltd.
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
-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
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