The BURAN Study of Buparlisib in Patients With Recurrent or Metastatic HNSCC
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04338399
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 487 participants
Conditions and interventions
Conditions
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 12, 2020 (Actual)
- Primary completion
- Nov 2, 2025 (Actual)
- Completion
- Nov 2, 2025 (Actual)
- Last update posted
- Nov 17, 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 17, 2025 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04338399 live on ClinicalTrials.gov.