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The BURAN Study of Buparlisib in Patients With Recurrent or Metastatic HNSCC

NCT04338399 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 487

Last updated 2025-11-17

No results posted yet for this study

Summary

The BURAN study is a randomized, open-label phase III study to assess the treatment effect of once-daily buparlisib in combination with weekly paclitaxel compared to weekly paclitaxel alone in patients with refractory, recurrent, or metastatic head and neck squamous cell carcinoma (HNSCC) that have progressed after prior anti PD 1/anti PD L1 monotherapy; prior anti PD 1/anti PD L1 therapy in combination with platinum-based therapy; or after sequential treatment of anti PD 1/anti PD L1 therapy, either prior to or post, platinum-based therapy.

Conditions

Interventions

DRUG

Buparlisib & Paclitaxel

Investigation drug plus paclitaxel

Sponsors & Collaborators

  • Adlai Nortye Biopharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Senior Director, Global Operations · Adlai Nortye USA Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-12
Primary Completion
2025-11-02
Completion
2025-11-02
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Canada
  • China
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Italy
  • Japan
  • Poland
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04338399 on ClinicalTrials.gov