An international multicenter, open, single-arm pivotal registration phase III study to determine the efficacy and safety of olverembatinib in patients with SDH-deficient gastrointestinal stromal tumor (GIST) who have previously been treated with one-line therapy, and to evaluate the progression-free survival and clinical benefit rate of olverembatinib in patients with SDH-deficient GIST.
This study intends to enroll patients with SDH-deficient GIST who have failed at least one systemic therapy to receive olverembatinib tablets 40mg orally administered with meals once every other day and every 28 days for a dosing cycle.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Oral administration with meal, QOD, every 28 days for a cycle.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGProgression-free survival(PFS) rate
Proportion of subjects who do not experience disease progression or death after the first dose of treatment as assessed by Independent Review Committee.
Time frame: 36 months
Plasma concentrations of olverembatinib
Blood samples will be collected to measure the plasma concentration of olverembatinib.
Time frame: Cycle 2 to Cycle 3 (each cycle is 28 days)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
According to CTCAE v5.0, the number and frequency of adverse events of test drug were assessed.
Time frame: Through study completion,an average of 2 years.
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