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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517251-12-00

Acronym

AN2025H0301

Enrollment

202

Registered

2024-09-24

Start date

2021-11-02

Completion date

2025-06-16

Last updated

2025-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent or metastatic head and neck squamous cell carcinoma

Brief summary

The primary endpoint of this study is OS.

Detailed description

Efficacy: 1. PFS 2. Overall response rate (ORR) 3. Duration of response (DoR) 4. OS, PFS, ORR and DoR in subgroups, Safety: 1. AEs 2.Clinical laboratory tests, Exploratory Endpoints: Biomarkers

Interventions

DRUGBuparlisib 50mg Tablet

DRUGBuparlisib 40mg Tablet

DRUGPaclitaxel 6 mg/ml concentrate for solution for infusion

DRUGBuparlisib 50 mg Capsules

DRUGBuparlisib 10 mg Capsules

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint of this study is OS.	—

Secondary

Measure	Time frame
Efficacy: 1. PFS 2. Overall response rate (ORR) 3. Duration of response (DoR) 4. OS, PFS, ORR and DoR in subgroups, Safety: 1. AEs 2.Clinical laboratory tests, Exploratory Endpoints: Biomarkers	—

Countries

Belgium, France, Germany, Hungary, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026