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PI3K Inhibitor
Buparlisib + Chemotherapy for Head and Neck Cancer (BURAN Trial)
Phase 3
Waitlist Available
Research Sponsored by Adlai Nortye Biopharma Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient has received no more than two prior lines of systemic treatment for HNSCC
Aged ≥18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up orr will be assessed for all patients 6 months after randomization is complete.
Awards & highlights
BURAN Trial Summary
This trial is testing whether adding the drug buparlisib to standard weekly chemotherapy treatment can help people with head and neck squamous cell carcinoma that has gotten worse despite other treatments.
Who is the study for?
Adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who have previously progressed after anti PD-1/PD-L1 therapy, alone or with platinum-based treatment. Participants must be in good physical condition, able to take oral medication, and not have had more than two systemic treatments for HNSCC.Check my eligibility
What is being tested?
The BURAN study is testing the effectiveness of buparlisib combined with paclitaxel versus paclitaxel alone in patients whose HNSCC has worsened despite prior therapies. This phase III trial randomly assigns participants to either the combination treatment or the single drug.See study design
What are the potential side effects?
Buparlisib may cause high blood sugar levels, rash, fatigue, nausea and liver issues. Paclitaxel can lead to allergic reactions, low blood cell counts increasing infection risk, nerve damage causing numbness or pain and muscle aches.
BURAN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had 2 or fewer treatments for head and neck cancer.
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I am 18 years old or older.
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I can swallow and keep down pills.
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My cancer diagnosis was confirmed through tissue examination.
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My cancer returned or worsened after treatment with PD1/PDL1 therapy.
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I am fully active and can carry on all pre-disease activities without restriction.
BURAN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ orr will be assessed for all patients 6 months after randomization is complete.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~orr will be assessed for all patients 6 months after randomization is complete.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
Health Related Quality of Life (QoL): Time to Definitive deterioration of Quality of Life as assessed by EORTC C30 questionnaire
Overall Response Rate
Pharmacokinetics of Buparlisib: plasma concentration-time profile of Buparlisib during 15 days of treatment
+2 moreBURAN Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Buparlisib & Weekly PaclitaxelExperimental Treatment1 Intervention
Drug: Patients will receive 100 mg (2 x 50 mg) buparlisib hard gel capsule administered orally, once daily starting on Day 1 of Treatment Cycle 1, Drug: Paclitaxel (80 mg/m2) administered intravenously (IV) on Days 1, 8, and 15 of a 21-day treatment cycle.
Treatment will continue until disease progression, unacceptable toxicity, death or discontinuation for any other reason.
Group II: Weekly PaclitaxelActive Control1 Intervention
Patients will receive weekly paclitaxel (80 mg/m2) administered intravenously (IV) on Days 1, 8, and 15 of a 21-day treatment cycle. Treatment will continue until disease progression, unacceptable toxicity, death or discontinuation for any other reason.
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Who is running the clinical trial?
Adlai Nortye Biopharma Co., Ltd.Lead Sponsor
7 Previous Clinical Trials
257 Total Patients Enrolled
Senior Director, Global OperationsStudy DirectorAdlai Nortye USA Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have symptoms from cancer spread to my brain.I have no cancer history, except for treated skin or in situ cancers.I have a heart condition.I have a stomach or intestine problem that affects how I absorb medicine.I have a history of or currently have a major mental health condition.I had major radiotherapy within the last month or small area radiotherapy in the last 2 weeks.I am currently taking medication that strongly affects liver enzyme CYP3A4.I have had 2 or fewer treatments for head and neck cancer.I am allergic to paclitaxel or its common premedications.I have not received a live vaccine in the last 30 days.I am 18 years old or older.I had major surgery less than 2 weeks ago.I can swallow and keep down pills.I have used a cancer treatment drug within the last 4 weeks.My bone marrow and organs are working well.I have severe nerve pain, inflammation of the colon or lungs, or hormone imbalances from past treatments.My cancer diagnosis was confirmed through tissue examination.I am currently taking warfarin or a similar blood thinner.I can provide tissue samples for cancer and HPV testing.I am on long-term steroids or other drugs that weaken my immune system.My cancer returned or worsened after treatment with PD1/PDL1 therapy.I have been treated with a taxane for my metastatic disease.I am fully active and can carry on all pre-disease activities without restriction.I have been treated with drugs targeting the PKB/AKT, mTOR, or PI3K pathways.
Research Study Groups:
This trial has the following groups:- Group 1: Weekly Paclitaxel
- Group 2: Buparlisib & Weekly Paclitaxel
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Buparlisib & Paclitaxel for therapeutic use?
"Buparlisib & Paclitaxel is in Phase 3 clinical trials, which means that while there is evidence of efficacy, much of the focus has been on safety. Power estimates that it falls at a 3 on our 1-3 scale."
Answered by AI
Can people with the required medical conditions join this clinical trial at this time?
"Yes, this trial is still open and looking for participants. According to the listing on clinicaltrials.gov, the study was posted December 12th 2020 and updated August 11th 2022."
Answered by AI
Out of how many people selected for this experiment are currently participating?
"That is correct, the online information for this clinical trial indicates that it is still recruiting patients. This research was originally posted on December 12th 2020 and was most recently edited on August 11th 2022. The study requires 483 participants across 2 locations."
Answered by AI
Are Buparlisib & Paclitaxel a common pairing in clinical research?
"Buparlisib & Paclitaxel was first studied in 1997 and, as of now, 1196 completed trials have been conducted. Out of the 874 ongoing studies, many are being hosted out of Tyler, Texas."
Answered by AI
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