Trial · NCT04338399
The BURAN Study of Buparlisib in Patients With Recurrent or Metastatic HNSCC
NCT04338399, Phase 3, Completed, Adlai Nortye Biopharma Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The BURAN Study of Buparlisib in Patients With Recurrent or Metastatic HNSCC. Trials, record NCT04338399. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04338399
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The BURAN Study of Buparlisib in Patients With Recurrent or Metastatic HNSCC
- NCT number
- NCT04338399
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 487 participants, actual
- Lead sponsor
- Adlai Nortye Biopharma Co., Ltd.
- Conditions
- Head and Neck Cancer
- Interventions
- Buparlisib & Paclitaxel
- First posted
- 2020-04-08
- Last updated
- 2025-11-17
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | Overall survival will be measured from time of randomization until death from any cause. The analysis will occur when all patients have been randomized and followed for 12 months. | To assess the OS of buparlisib in combination with paclitaxel compared to paclitaxel alone in patients with recurrent or metastatic HNSCC |
| Secondary | Progression free survival | PFS will be assessed up to 24 months after all patients are randomized | Defined as the time from randomization date until tumor progression or death from any cause. |
| Secondary | Overall Response Rate | ORR will be assessed for all patients 6 months after randomization is complete. | Defined at the proportion of patients with a complete or partial response |
| Secondary | Health Related Quality of Life (QoL): Time to Definitive deterioration of Quality of Life as assessed by EORTC C30 questionnaire | Assessments will be made from randomization until treatment discontinuation | A summary of EORTC-QLQ-C30 scores by time window. Time to deterioration is the number of days between the date of randomization and the date of the assessment when definitive deterioration is seen. Definitive deterioration is defined as a decrease in the sub scale score by at least 10% compared with baseline. |
| Secondary | Safety and Tolerability of Buparlisib in combination with Paclitaxel compared with Paclitaxel alone as Measured by Number of Participants Experiencing Adverse Events (AEs). | From screening until 4 weeks following treatment discontinuation | Treatment Emergent Adverse Events AEs will be assessed according to the NCI-CTCAE version 5.0 for severity and will be recorded and classified on the basis of MedDRA terminology. Anxiety score change from baseline taken at time of screening (General Anxiety Disorder 7 item scale) until end of treatment. Depression score change from baseline taken at time of screening (Patient Health Questionnaire 9) until end of treatment. |
| Secondary | Pharmacokinetics of Buparlisib: plasma concentration-time profile of Buparlisib during 15 days of treatment | Day 0 to Day 15 sparse sampling | For Sparse PK sampling, blood samples will be collected on Treatment Cycle 1, Days 1, 8, and 15 at pre-dose, 1 (± 0.25), 2 ± (0.25) and 6 ± (0.5) hours post-dose. PK sampling will be collected only for those patients randomized to the buparlisib in combination with paclitaxel arm and pharmacokinetic profile of Buparlisib combined with paclitaxel in the study population will be compared with a simulated population PK model. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04338399
GET https://conductscience.org/api/trials/v1/NCT04338399/registered