West Cancer Center

Head and neck: Metastatic: 2nd line: Buparlasib: BURAN

The BURAN Study of Buparlisib (AN2025) In Combination With Paclitaxel Compared to Paclitaxel Alone, in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Title

Adlai Nortye AN2025H0301 BURAN Head and Neck

Study Title

The BURAN Study of Buparlisib (AN2025) In Combination With Paclitaxel Compared to Paclitaxel Alone, in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Site Link

NCT04338399

Malignancy

Head and Neck cancer, oropharynx, hypopharynx, larynx, oral cavity, hypopharyngeal, oropharyngeal, laryngeal

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

2nd line

Investigational Agent

Buparlisib

Drug Class

PI3K inhibitor

Gary Tian, MD

Sponsor

Adlai Nortye Biopharma Co.

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

Key Eligibility Criteria Details

Must have one of the following
- Disease progression after platinum based chemotherapy (with or without PD-1 therapy) for recurrent or metastatic disease
- Refractory disease defined as progression or recurrence within six months after the last dose of platinum based chemoradiation for locally advanced disease
No more than two prior lines of treatment
ECOG PS 0-1
Able to swallow and retain oral medications
No prior taxane
No symptomatic CNS disease
No known HIV
No symptomatic CHF or LVEF <50%
No active psychiatric illness

Objective

Primary
- OS
Secondary
- PFS
- ORR
- PRO
- Safety
- PK

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Head and neck cancer

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes