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

• Status: Active, not recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zai Lab (Shanghai) Co., Ltd.

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.