A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib
Gastrointestinal Stromal Tumor (GIST)
18 Years and older, Male and Female
DCC-2618-03-002 (primary)
NCI-2019-00046
Summary
This is a 2-arm, randomized, open-label, international, multicenter study comparing the
efficacy of ripretinib to sunitinib in GIST patients who progressed on or were intolerant to
first-line anticancer treatment with imatinib. Approximately 426 patients will be randomized
in a 1:1 ratio to ripretinib 150 mg once daily (continuous dosing for 6 week cycles) or
sunitinib 50 mg once daily (6 week cycles, 4 weeks on, 2 weeks off).
Eligibility
- Patients = 18 years of age at the time of informed consent.
- Histologic diagnosis of GIST and must be able to provide an archival tumor tissue sample, otherwise, a fresh biopsy is required.
- Molecular pathology report must be available. If molecular pathology report is not available or insufficient, an archival tumor tissue sample or fresh biopsy is required for mutation status confirmation by the central laboratory prior to randomization.
- Patients must have progressed on imatinib or have documented intolerance to imatinib.
- Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) of = 2 at screening.
- Female patients of childbearing potential must have a negative serum beta-human chorionic gonadotropin (ß-hCG) pregnancy test at screening and negative pregnancy test at Cycle 1 Day 1 prior to the first dose of study drug.
- Patients of reproductive potential must agree to follow the contraception requirements outlined in the study protocol.
- Patients must have at least 1 measurable lesion according to Modified Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1 (non nodal lesions must be = 1.0 cm in the long axis or = double the slice thickness in the long axis) within 21 days prior to the first dose of study drug.
- Adequate organ function and bone marrow reserve as indicated by the central laboratory assessments performed at screening.
- Resolution of all toxicities from prior therapy to = Grade 1 (or patient baseline) within 1 week prior to the first dose of study drug (excluding alopecia and = Grade 3 clinically asymptomatic lipase, amylase, and creatine phosphokinase laboratory abnormalities).
- The patient is capable of understanding and complying with the protocol and the patient has signed the informed consent document. Signed informed consent form (ICF) must be obtained before any study-specific procedures are performed and the patient must agree to not participate in any other interventional clinical trial while on treatment in this clinical trial. Participation in a noninterventional study (including observational studies) is permitted.
Treatment Sites in Georgia
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