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
Malignancy
Head and Neck cancer, oropharynx, hypopharynx, larynx, oral cavity, hypopharyngeal, oropharyngeal, laryngeal
Sponsor
Adlai Nortye Biopharma Co.
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