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Buparlisib & Paclitaxel · 1 trial · 1 indication
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...
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Buparlisib and Paclitaxel is an investigational combination being studied for the treatment of head and neck cancer, specifically recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). It is a small molecule therapy in Phase 3 clinical development for this oncology indication.
Buparlisib and Paclitaxel is being developed by Adlai Nortye Ltd., a biopharmaceutical company whose American Depositary Shares trade under the ticker ANL. The company is conducting clinical research on this combination for head and neck cancer.
Buparlisib and Paclitaxel is in Phase 3 clinical development for head and neck cancer. It is an investigational therapy, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy.
Buparlisib and Paclitaxel was studied in the BURAN Study, registered as NCT04338399, a Phase 3 trial in patients with recurrent or metastatic head and neck squamous cell carcinoma. This randomized, active-controlled trial enrolled 487 participants across multiple countries and has been completed.
Buparlisib and Paclitaxel is a combination regimen that includes buparlisib, a PI3K inhibitor, together with paclitaxel, a chemotherapy agent. While buparlisib can be studied as a single agent, this specific drug asset refers to the combination of the two drugs for treating head and neck cancer.