At a glance
ClinicalIndex Comparison RecordPhase 3Recruiting· 40 target
Drug / intervention
Olverembatinibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single-Arm Registrational Phase III Study of Olverembatinib in the Treatment of Patients With SDH-Deficient Gastrointestinal Stromal Tumor (POLARIS-3)
In Brief
A Phase 3 clinical trial evaluating Olverembatinib for GIST. Currently recruiting, targeting 40 participants across 1 site.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGIST
CountriesChina
CollaboratorsHealthQuest Pharma Inc.
Timeline
Phase 3Recruiting
20252026202720282029
First PostedOct 2024
Enrollment StartNov 2024
TodayJul 2026
Primary CompletionMar 2027
Study CompletionJun 2029
First PostedOct 15, 2024
Enrollment StartNov 11, 2024
Primary CompletionMar 31, 2027
Study CompletionJun 30, 2029
TodayJul 1, 2026
Enrollment to primary: 2.4 yearsPosted 1.7 years agoPrimary completion in 9 months
Interventions
Olverembatinibdrug
Oral administration with meal, QOD, every 28 days for a cycle.