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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07465757 | A Study of Alisertib and Paclitaxel in Patients With Small Cell Lung Cancer (SCLC) | PHASE2 | NOT YET_RECRUITING | 50 | — | — | Sep 30, 2026 | Sep 30, 2028 | Mar 12, 2026 | - | — |
Treatment emergent adverse events are those events reported on or after the first dose of investigational product and up to 28 days after the last dose.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Alisertib 30 mg BID + Paclitaxel | EXPERIMENTAL | Approximately ten participants will be enrolled in the cohort. Alisertib dose may be increased by 10 mg BID in the next cohort if 3 or fewer participants experience an Event during Cycle 1. |
| Cohort 2: Alisertib 40 mg BID + Paclitaxel | EXPERIMENTAL | Approximately ten participants will be enrolled in the cohort. Alisertib dose may be increased by 10 mg BID in the next cohort if 3 or fewer participants experience an Event during Cycle 1. |
| Cohort 3: Alisertib 50 mg BID + Paclitaxel | EXPERIMENTAL | Approximately ten participants will be enrolled in the cohort. Alisertib dose may be increased by 10 mg BID in the next cohort if 3 or fewer participants experience an Event during Cycle 1. |
| Cohort 4: Alisertib 60 mg BID + Paclitaxel | EXPERIMENTAL | Approximately ten participants will be enrolled in the cohort. Alisertib dose may be increased by 10 mg BID in the next cohort if 3 or fewer participants experience an Event during Cycle 1. |
| Cohort 5: Alisertib 70 mg BID + Paclitaxel | EXPERIMENTAL | Approximately ten participants will be enrolled in the cohort. |
| Name | Type | Description |
|---|---|---|
| Alisertib | DRUG | Alisertib enteric-coated tablets, 30 mg BID self-administered orally on Days 1-7 of every 21-day cycle |
| Paclitaxel | DRUG | 60 mg/m\^2 IV on Days 1 and 8 of every 21-day cycle |
Inclusion Criteria: * Aged ≥18 years at signing of informed consent * Pathologically confirmed SCLC * Prior treatment with one platinum-based chemotherapy and an anti-PD-1/PD-L1 immunotherapy. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to 2 prior treatm...