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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04338399 | The BURAN Study of Buparlisib in Patients With Recurrent or Metastatic HNSCC | PHASE3 | COMPLETED | 487 | — | — | Dec 12, 2020 | Nov 2, 2025 | Nov 17, 2025 | 162 | United States, Argentina +15 |
To assess the OS of buparlisib in combination with paclitaxel compared to paclitaxel alone in patients with recurrent or metastatic HNSCC
| Arm | Type | Description |
|---|---|---|
| Buparlisib & Weekly Paclitaxel | EXPERIMENTAL | Drug: Patients will receive 100 mg (2 x 50 mg) buparlisib hard gel capsule administered orally, once daily starting on Day 1 of Treatment Cycle 1, Drug: Paclitaxel (80 mg/m2) administered intravenously (IV) on Days 1, 8, and 15 of a 21-day treatment cycle. Treatment will continue until disease progression, unacceptable toxicity, death or discontinuation for any other reason. |
| Weekly Paclitaxel | ACTIVE_COMPARATOR | Patients will receive weekly paclitaxel (80 mg/m2) administered intravenously (IV) on Days 1, 8, and 15 of a 21-day treatment cycle. Treatment will continue until disease progression, unacceptable toxicity, death or discontinuation for any other reason. |
| Name | Type | Description |
|---|---|---|
| Buparlisib & Paclitaxel | DRUG | Investigation drug plus paclitaxel |
Inclusion Criteria: 1. Aged ≥18 years old. 2. Able to provide informed consent obtained before any trial related activities and according to local guidelines. 3. Patient has histologically and/or cytologically-confirmed HNSCC. 4. Patient has archival or new tumor tissue for the analysis of biomarke...