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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT04338399

Public ClinicalTrials.gov record NCT04338399. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 6, 2026, 8:23 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official 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

Study identification

NCT ID
NCT04338399
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Adlai Nortye Biopharma Co., Ltd.
Industry
Enrollment
487 participants

Conditions and interventions

Interventions

  • Buparlisib & Paclitaxel Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 11, 2020
Primary completion
Nov 1, 2025
Completion
Nov 1, 2025
Last update posted
Nov 16, 2025

2020 – 2025

United States locations

U.S. sites
21
U.S. states
15
U.S. cities
20
Facility City State ZIP Site status
City of Hope Duarte California 91010
Yale University, Yale Cancer Center New Haven Connecticut 06511
Moffitt Cancer Center Tampa Florida 33612
Emory University Atlanta Georgia 30322
Northwestern University Chicago Illinois 60611
University of Kentucky Lexington Kentucky 40536
Norton Cancer Institute Louisville Kentucky 40202
University of Michigan Ann Arbor Michigan 48109
Karmanos Cancer Institute Detroit Michigan 48201
Henry Ford Health System Detroit Michigan 48202
Washington University School of Medicine St Louis Missouri 63130
NYU Langone New York New York 10016
Stony Brook University Medical Center Stony Brook New York 11794
Montefiore Medical Center The Bronx New York 10461
Duke University Medical Center Durham North Carolina 27710
University of Cincinnati Cancer Center Cincinnati Ohio 45219
Fox Chase Cancer Center Philadelphia Pennsylvania 19111
UPMC Hillman Cancer Center Pittsburgh Pennsylvania 15232
Hollings Cancer Center Charleston South Carolina 29425
West Cancer Center Germantown Tennessee 38138
Hope Cancer Center, UT Health East Texas Tyler Texas 75701

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 141 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04338399, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 16, 2025 · Synced May 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04338399 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →