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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05208047 | (Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors | PHASE3 | ACTIVE NOT_RECRUITING | 482 | — | — | Apr 14, 2022 | Jan 1, 2030 | May 22, 2026 | 110 | United States, Argentina +20 |
Maximum plasma concentration (Cmax)
Area under the plasma concentration-time curve (AUC)
Maximum plasma concentration (Cmax)
Area under the plasma concentration-time curve (AUC)
Time to maximum observed plasma concentration (Tmax)
Time from first dose to documented disease progression or death due to any cause, whichever occurs first
Area under the plasma concentration-time curve (AUC)
Maximum plasma concentration (Cmax)
| Arm | Type | Description |
|---|---|---|
| Part 1a | EXPERIMENTAL | CGT9486 plus sunitinib 37.5 mg QD |
| Part 2 - Experimental Group | EXPERIMENTAL | CGT9486 plus sunitinib 37.5 mg QD |
| Part 2 - Control Group | ACTIVE_COMPARATOR | sunitinib 37.5 mg QD |
| Part 1b - DDI Cohort 1 | EXPERIMENTAL | CGT9486 plus sunitinib 37.5 mg QD |
| Part 1b - DDI Cohort 2 | EXPERIMENTAL | sunitinib 37.5 mg QD plus CGT9486 |
| DDI Substudy (Midazolam) | EXPERIMENTAL | Midazolam, CGT9486, sunitinib |
| GIST 1L Substudy | EXPERIMENTAL | CGT9486, sunitinib |
| Name | Type | Description |
|---|---|---|
| CGT9486 plus sunitinib | DRUG | Participants will receive both CGT9486 and sunitinib orally until study stopping rules are met. |
| CGT9486 | DRUG | Participants will receive CGT9486 until steady state then both CGT9486 and sunitinib orally until study stopping rules are met. |
| Sunitinib | DRUG | Participants will receive sunitinib until steady state then both sunitinib and CGT9486 orally until study stopping rules are met. |
| Midazolam | DRUG | Participants will receive a single-dose of midazolam on Day 1 and Day 16 |
Key Inclusion Criteria: 1. Histologically confirmed locally advanced, metastatic, and/or unresectable GIST. Molecular pathology report must be available for Part 2; if molecular pathology report is unavailable or inadequate, an archival or fresh tumor tissue sample will be required to evaluate muta...