Buparlisib + Chemotherapy for Head and Neck Cancer

(BURAN Trial)

Recruiting at162 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Adlai Nortye Biopharma Co., Ltd.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a combination of two drugs, buparlisib and paclitaxel, for patients with head and neck cancer that has returned or spread after other treatments. Buparlisib is taken regularly to stop cancer cells from growing, and paclitaxel is given periodically to prevent them from multiplying. The goal is to see if this combination works better than using paclitaxel alone.

Research Team

Senior Director, Global Operations

Principal Investigator

Adlai Nortye USA Inc.

Eligibility Criteria

Adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who have previously progressed after anti PD-1/PD-L1 therapy, alone or with platinum-based treatment. Participants must be in good physical condition, able to take oral medication, and not have had more than two systemic treatments for HNSCC.

Inclusion Criteria

Able to provide informed consent obtained before any trial related activities and according to local guidelines

I have had 2 or fewer treatments for head and neck cancer.

Patient has measurable disease as determined per RECIST version 1.1

Exclusion Criteria

Patient is pregnant or nursing

I have symptoms from cancer spread to my brain.

I have no cancer history, except for treated skin or in situ cancers.

Treatment Details

Interventions

• Buparlisib (PI3K Inhibitor)
• Paclitaxel (Mitotic Inhibitor)

Trial Overview The BURAN study is testing the effectiveness of buparlisib combined with paclitaxel versus paclitaxel alone in patients whose HNSCC has worsened despite prior therapies. This phase III trial randomly assigns participants to either the combination treatment or the single drug.

Participant Groups

Group I: Buparlisib & Weekly Paclitaxel Experimental Treatment 1 Intervention

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.

Group II: Weekly Paclitaxel Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Adlai Nortye Biopharma Co., Ltd.

Lead Sponsor

Trials

8

Recruited

740+