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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03465722 | (VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST | PHASE3 | COMPLETED | 476 | — | — | Mar 26, 2018 | Sep 15, 2021 | Oct 6, 2022 | 114 | United States, Australia +16 |
To demonstrate the efficacy of avapritinib based on progression-free survival (PFS) determined by central radiological assessment per modified Response Evaluation Criteria in Solid Tumors (mRECIST), version 1.1 in patients with advanced GIST following 2 or 3 regimens of prior treatment with a tyrosine kinase inhibitor (TKI), including imatinib, compared to patients treated with regorafenib. A progressively growing tumor must meet the following criteria: a) the target lesions must be greater or equal to 2cm in size and be a new GIST active lesion or b) the target lesions must be expanding on at least 2 sequential imaging studies.
| Arm | Type | Description |
|---|---|---|
| avapritinib | EXPERIMENTAL | 300 mg PO QD |
| regorafenib | ACTIVE_COMPARATOR | 160 mg PO QD |
| Name | Type | Description |
|---|---|---|
| avapritinib | DRUG | Avapritinib tablets for oral administration. Avapritinib will be dosed at 300 mg once daily, continuously. |
| regorafenib | DRUG | Regorafenib tablets for oral administration. Regorafenib will be dosed at 160 mg once daily for 3 weeks out of every 4 weeks (ie. 3 weeks on/1 week off). |
Inclusion Criteria: 1. Patients who are ≥ 18 years of age. 2. Patients who have histologically confirmed metastatic or unresectable GIST. 3. Patients who received imatinib and 1 or 2 other TKIs as prior treatment regimens. Patients who experienced intolerance to prior therapies must have objective ...