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.

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Updated on 19 February 2024

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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	18-100 years
Treatment	DCC-2618
Clinical Study Identifier	NCT04282980
Sponsor	Zai Lab (Shanghai) Co., Ltd.
Last Modified on	19 February 2024

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