Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04633122 | A Study to Assess DCC-2618 and Sunitinib in Patients With Advanced GIST After Treatment With Imatinib | PHASE2 | COMPLETED | 108 | — | — | Nov 25, 2020 | Jul 20, 2022 | Apr 3, 2026 | 18 | China |
PFS is defined as the time interval from randomization to the first occurrence of progressive disease based on assessment of the independent radiology review (IRR) or death due to any causes.
| Arm | Type | Description |
|---|---|---|
| Ripretinib | EXPERIMENTAL | 50mg/tablet,150 mg QD continuous administration, 6 weeks (42 days) for a cycle. |
| Sunitinib | ACTIVE_COMPARATOR | 12.5mg/capsule, 50 mg QD, in 6 weeks (42 days) with 4 weeks continuous dosing followed by 2 weeks break. |
| Name | Type | Description |
|---|---|---|
| Ripretinib | DRUG | Oral kinase inhibitor |
| Sunitinib | DRUG | second-line therapy in GIST patients who have progressed after imatinib treatment or are intolerant to imatinib |
Inclusion Criteria: * Male or female patients ≥18 years of age. * Histological diagnosis of advanced GIST and capability of providing tumor tissue sample (the interval between tumor tissue collection and signing of informed consent form should be less than 3 years). Otherwise, biopsy is required. *...