Head and Neck Squamous Cell CarcinomaPhase 2NCT01852292
Study of Efficacy and Safety of Buparlisib (BKM120) Plus Paclitaxel Versus Placebo Plus Paclitaxel in Recurrent or Metastatic Head and Neck Cancer Previously Pre-treated With a Platinum Therapy
A Phase 2 study testing Buparlisib and Paclitaxel in people with Head and Neck Squamous Cell Carcinoma, run by Novartis Pharmaceuticals at 58 sites in 18 countries.
Trial summary
Phase II Study of efficacy and safety of buparlisib (BKM120) plus paclitaxel versus placebo plus paclitaxel in recurrent or metastatic Head and Neck cancer previously pre-treated with a platinum therapy.The primary endpoint was PFS and the key secondary endpoint was Overall Survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Buparlisib and Paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 58 sitesin 18 countries
- Study dates
- 1 Oct 2013to 30 Mar 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has histologically/cytologically-confirmed HNSCC.
- Patient has archival or fresh tumor tissue for the analysis of PI3K-related biomarkers. One tumor block (preferred) or a minimum of 12 unstained slides to be provided. Enrollment in the study is contingent on confirmation of an adequate amount of tumor tissue.
- Patients with recurrent or metastatic disease resistant to platinum-based chemotherapy (defined as progression while on platinum-based chemotherapy given in the recurrent/metastatic setting). Pretreatment with cetuximab is allowed
- Measurable disease as determined by per RECIST criteria v1.1. If the only site of measurable disease is a previously irradiated lesion, documented progression of disease and a 4 week period since radiotherapy completion is required
- Adequate bone marrow function and organ function
- ECOG Performance Status ≤ 1
Who cannot join
- Patient has received previous treatment with any AKT, mTOR inhibitors or PI3K pathway inhibitors;
- Patient treated with more than one prior chemotherapy regimen for recurrent/metastatic disease
- Patient has symptomatic CNS metastases. Patients with asymptomatic CNS metastases may participate in this trial. The patient must have completed any prior local treatment for CNS metastases ≥ 28 days prior to the start of study treatment (including radiotherapy and/or surgery) and must have stable low dose of corticosteroid therapy;
- Patient has not recovered to ≤ grade 1 (except alopecia) from related side effects of any prior antineoplastic therapy
- Patient has any of the following cardiac abnormalities:symptomatic congestive heart failure, history of documented congestive heart failure (New York Heart Association functional classification III-IV), documented cardiomyopathy, Left Ventricular Ejection Fraction (LVEF) <50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO); myocardial infarction ≤ 6 months prior to enrolment, unstable angina pectoris, serious uncontrolled cardiac arrhythmia, symptomatic pericarditis, QTcF > 480 msec on the screening ECG (using the QTcF formula);
Trial locations and contacts
58 sites in 18 countries.
58 sites in 18 countries
Italy9 sites
Novartis Investigative Site
Florence, FI, 50134
Novartis Investigative Site
Milan, MI, 20133
Novartis Investigative Site
Milan, MI, 20141
Novartis Investigative Site
Milan, MI, 20142
Novartis Investigative Site
Palermo, PA, 90127
Novartis Investigative Site
Roma, RM, 00168
Novartis Investigative Site
Salerno, SA, 84131
Novartis Investigative Site
Torino, TO, 10126
Novartis Investigative Site
Venezia, VE, 30174
United States7 sites
Dana Farber Cancer Institute IRB
Boston, Massachusetts, 02215
University of N.C. at Chapel Hill Lineberger Comp. Cancer Ctr.
Chapel Hill, North Carolina, 27599-7600
University Hospitals Case Medical Center Univ. Hospitals of Cleveland
Cleveland, Ohio, 44106
Highlands Oncology Group
Fayetteville, Arkansas, 72703
The Mount Sinai Hospital Dept of Oncology
New York, New York, 10029
UPMC Cancer Centers BKM120H2201
Pittsburgh, Pennsylvania, 15232
Washington U School of Medicine Center for Clinical Studies SC - BKM120H2201
St Louis, Missouri, 63110
India6 sites
Novartis Investigative Site
Dehli, New Delhi, 110005
Novartis Investigative Site
Jaipur, Rajasthan, 302017
Novartis Investigative Site
Kerala, 695 011
Novartis Investigative Site
Kolkata, West Bengal, 700160
Novartis Investigative Site
Mumbai, 400 012
Novartis Investigative Site
Nashik, Maharashtra, 422 004
Hungary4 sites
Novartis Investigative Site
Budapest, 1082
Novartis Investigative Site
Budapest, H-1115
Novartis Investigative Site
Budapest, H-1122
Novartis Investigative Site
Nyíregyháza, 4400
United Kingdom4 sites
Novartis Investigative Site
Glasgow, Scotland, G12 0YN
Novartis Investigative Site
London, NW1 2PJ
Novartis Investigative Site
London, SE1 9RT
Novartis Investigative Site
Manchester, M20 9BX
Germany3 sites
Novartis Investigative Site
Berlin, 12203
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Hanover, 30625
Japan3 sites
Novartis Investigative Site
Kashiwa, Chiba, 277-8577
Novartis Investigative Site
Koto-ku, Tokyo, 135 8550
Novartis Investigative Site
Minato-ku, Tokyo, 105-8471
Russia3 sites
Novartis Investigative Site
Leningrad Region, Russia, 188663
Novartis Investigative Site
Nizhny Novgorod
Novartis Investigative Site
Saint Petersburg, 197758
Spain3 sites
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
L'Hospitalet de Llobregat, Catalonia, 08907
Novartis Investigative Site
Madrid, 28034
Taiwan3 sites
Novartis Investigative Site
Kaohsiung City, 83301
Novartis Investigative Site
Taichung, 407
Novartis Investigative Site
Tainan, Taiwan ROC, 70421
Thailand3 sites
Novartis Investigative Site
Bangkok, 10330
Novartis Investigative Site
Bangkok, 10700
Novartis Investigative Site
Songkhla, Hat Yai, 90110
Canada2 sites
Novartis Investigative Site
Hamilton, Ontario, L8V 5C2
Novartis Investigative Site
Montreal, Quebec, H2L 4M1
South Korea2 sites
Novartis Investigative Site
Seoul, Korea, 05505
Novartis Investigative Site
Seoul, Seocho-gu, 06591
Switzerland2 sites
Novartis Investigative Site
Basel, 4031
Novartis Investigative Site
Geneva, 1211
Australia1 site
Novartis Investigative Site
St Leonards, New South Wales, 2065
About this study
Official title: Double Blind, Placebo Controlled Study Assessing the Efficacy of Buparlisib (BKM120) Plus Paclitaxel Versus Placebo Plus Paclitaxel in Patients With Platinum Pre-treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
Phase II Study of efficacy and safety of buparlisib (BKM120) plus paclitaxel versus placebo plus paclitaxel in recurrent or metastatic Head and Neck cancer previously pre-treated with a platinum therapy.The primary endpoint was PFS and the key secondary endpoint was Overall Survival.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Buparlisib, Buparlisib matching Placebo, Paclitaxel
- Keywords
- platinum pre-treated recurrent or metastatic, Head and neck squamous cell carcinoma, recurrent, metastatic, BKM120
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Neoplasm Metastasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuparlisibDrug
Also called BKM120
Buparlisib comes in gelatin capsules and is taken orally at a dose of 100 mg/day.
Buparlisib matching PlaceboDrug
Buparlisib matching placebo comes in gelatin capsules and is taken orally at a dose of 100 mg/day.
PaclitaxelDrug
Paclitaxel is an intravenous infusion that is given once every week in 80 mg/m^2.
| Study group | Role | What they receive |
|---|---|---|
| Buparlisib + weekly Paclitaxel | Experimental | Patients who were randomized to this arm on a 1:1 randomization, took buparlisib 100 mg daily and paclitaxel 80 mg/m^2 weekly. Receives: Drug: Buparlisib; Drug: Paclitaxel |
| Buparlisib matching placebo + Paclitaxel | Placebo comparator | Patients who were randomized to this arm on a 1:1 randomization, took buparlisib matching placebo 100 mg daily and paclitaxel 80 mg/m^2 weekly. Receives: Drug: Buparlisib matching Placebo; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) Per Investigator Assessment
PFS was defined as the time from the date of randomization to the date of the event, defined as the first radiologically documented disease progression per RECIST v. 1.1 or death due to any cause. If a patient has not progressed or died at the analysis cut-off date or when the patient receives further anti-neoplastic therapy, PFS was censored on the date of the last adequate tumor assessment before the earlier of the cut-off date or start of the further anti-neoplastic therapy date.
Measured: 4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years
Secondary outcomes (11)
Overall Survival (OS)
Overall survival (OS) was defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died by the date of analysis cut-off, OS was censored at the date of last contact.
Measured: 4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years
Overall Response Rate (ORR) as Per Local Radiological Assessment
ORR: percentage of patients with best overall response of complete response (CR) or partial response (PR) according to RECIST v1.1. CR is defined as disappearance of all target lesions and any pathological lymph nodes must have a short axis of <10 mm and the disappearance of all non-target lesions). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters or the persistence of 1 or more non-target lesions or lymph nodes identified as a site of disease at Baseline with a short axis of ≥10mm).
Measured: 4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years
Time to Response (TTR) as Per Local Radiological Assessment
TTR is the time from date of randomization until first documented response (CR or PR, which has to be confirmed subsequently) according to RECIST v1.1. CR is defined as disappearance of all target lesions and any pathological lymph nodes must have a short axis of <10 mm and the disappearance of all non-target lesions). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters or the persistence of 1 or more non-target lesions or lymph nodes identified as a site of disease at Baseline with a short axis of ≥10mm).
Measured: 4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years
Disease Control Rate (DCR) as Per Local Radiological Assessment
DCR is the percentage of patients with a best overall response of CR, PR or stable disease (SD), according to RECIST v1.1. CR is defined as disappearance of all target lesions \& any pathological lymph nodes must have a short axis of <10 mm \& the disappearance of all non-target lesions). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters or the persistence of 1 or more non-target lesions or lymph nodes identified as a site of disease at Baseline with a short axis of ≥10mm). SD is defined as neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm^2.
Measured: 4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years
Duration of Response (DoR) as Per Local Investigator
DoR is the time from the date of the first documented response (CR or PR, which had to be confirmed subsequently) to the date of the first radiologically documented disease progression or death due to disease according to RECIST v1.1 .
Measured: 4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years
Health-related Quality of Life (HRQoL):Time to 10% Definitive Deterioration in the Global Health Status/Quality of Life Per EORTC-QLQ-C30
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 at which definitive deterioration is seen. Definitive Deterioration in global health status and symptoms was defined as a decrease in the subscale score by at least 10% compared to baseline, with no later increase above this threshold observed during the course of the study. If a patient had not had an event prior to analysis cut-off or start of another anticancer therapy, time to deterioration was censored at the date of the last quality of life (QoL) evaluation.
Measured: Baseline, every 6 weeks starting from cycle 2 day 15 up to 3.5 years
Health-related Quality of Life (HRQoL):Time to 10% Definitive Deterioration in the Head and Neck Cancer Symptoms Scales for Pain, Speech Problems, Swallowing and Sense Problems Per EORTC-QLQ-HN35
A summary of EORTC-QLQ-HN35 scores by time window. Time to deterioration is the number of days between the date of randomization and the date of the assessment at which definitive deterioration is seen. Definitive Deterioration in global health status and symptoms was defined as an increase in the subscale score of at least 10% compared to baseline, with no later decrease above this threshold observed during the course of the study. If a patient had not had an event prior to analysis cut-off or start of another anticancer therapy, time to deterioration was censored at the date of the last quality of life (QoL) evaluation.
Measured: Baseline, every 6 weeks starting from cycle 2 day 15 up to 3.5 years
Plasma Concentration-time Profiles of BKM120 Pharmacokinetics (PK) for AUC0-24 and AUClast
To Characterize PK of buparlisib given in combination with paclitaxel for AUC0-24 (area under plasma concentration-time curve from time 0 to end of dosing interval of 24 hours) \& AUClast (AUC from time 0 to last measurable concentration sampling time).
Measured: Time point(s) at which PK samples for Non-Compartmental analysis were collected were 0, 0.5,1,1.5, 2, 3, 4, 6, 9 and 24 hours at Cycle 1, Day 15
Plasma Concentration-time Profiles of BKM120 Pharmacokinetics (PK) for Cmax
To characterize the pharmacokinetics of buparlisib given in combination with paclitaxel for Cmax.
Measured: Time point(s) at which PK samples for Non-Compartmental analysis were collected were 0, 0.5,1,1.5, 2, 3, 4, 6, 9 and 24 hours at Cycle 1, Day 15
Plasma Concentration-time Profiles of BKM120 Pharmacokinetics (PK) for Tmax
To characterize the pharmacokinetics of buparlisib given in combination with paclitaxel for Tmax.
Measured: Time point(s) at which PK samples for Non-Compartmental analysis were collected were 0, 0.5,1,1.5, 2, 3, 4, 6, 9 and 24 hours at Cycle 1, Day 15
Plasma Concentration-time Profiles of BKM120 Pharmacokinetics (PK) for CL/F
To characterize the pharmacokinetics of buparlisib given in combination with paclitaxel for CL/F.
Measured: Time point(s) at which PK samples for Non-Compartmental analysis were collected were 0, 0.5,1,1.5, 2, 3, 4, 6, 9 and 24 hours at Cycle 1, Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2013 (estimated)
- Study start1 Oct 2013
- Primary completion30 Mar 2017
- Study completion30 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852292
- Sponsor's protocol ID
- CBKM120H2201
- Other IDs
- 2013-000744-26
- Status last verified
- Jun 2018
- First submitted
- 8 May 2013
- Last updated
- 24 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Publications
Desilets A, Lucas J, Licitra LF, Lu S, Tse A, Tang T, Dreyer K, He N, Birgerson LE, Faivre S, Soulieres D. Buparlisib and Paclitaxel in Patients with Head and Neck Squamous Cell Carcinoma: Immunogenomic Biomarkers of Efficacy from the BERIL-1 Study. Target Oncol. 2025 Mar;20(2):299-310. doi: 10.1007/s11523-024-01126-0. Epub 2025 Jan 14.
PubMed 39808408Soulieres D, Faivre S, Mesia R, Remenar E, Li SH, Karpenko A, Dechaphunkul A, Ochsenreither S, Kiss LA, Lin JC, Nagarkar R, Tamas L, Kim SB, Erfan J, Alyasova A, Kasper S, Barone C, Turri S, Chakravartty A, Chol M, Aimone P, Hirawat S, Licitra L. Buparlisib and paclitaxel in patients with platinum-pretreated recurrent or metastatic squamous cell carcinoma of the head and neck (BERIL-1): a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Oncol. 2017 Mar;18(3):323-335. doi: 10.1016/S1470-2045(17)30064-5. Epub 2017 Jan 26.
PubMed 28131786
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Placebo Controlled Study Assessing the Efficacy of Buparlisib (BKM120) Plus Paclitaxel Versus Placebo Plus Paclitaxel in Patients With Platinum Pre-treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
- ClinicalTrials.gov ID
- NCT01852292
- Acronym / sponsor ID
- CBKM120H2201
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- platinum pre-treated recurrent or metastatic, Head and neck squamous cell carcinoma, recurrent, metastatic, BKM120
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 30 Mar 2017 (actual)
- Study completion
- 30 Mar 2017 (actual)
- First posted
- 13 May 2013 (estimated)
- Results
- Posted 26 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase II Study of efficacy and safety of buparlisib (BKM120) plus paclitaxel versus placebo plus paclitaxel in recurrent or metastatic Head and Neck cancer previously pre-treated with a platinum therapy.The primary endpoint was PFS and the key secondary endpoint was Overall Survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buparlisib + weekly Paclitaxel | Experimental | Drug: Buparlisib, Drug: PaclitaxelPatients who were randomized to this arm on a 1:1 randomization, took buparlisib 100 mg daily and paclitaxel 80 mg/m^2 weekly. |
| Buparlisib matching placebo + Paclitaxel | Placebo comparator | Drug: Buparlisib matching Placebo, Drug: PaclitaxelPatients who were randomized to this arm on a 1:1 randomization, took buparlisib matching placebo 100 mg daily and paclitaxel 80 mg/m^2 weekly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient has histologically/cytologically-confirmed HNSCC.
- Patient has archival or fresh tumor tissue for the analysis of PI3K-related biomarkers. One tumor block (preferred) or a minimum of 12 unstained slides to be provided. Enrollment in the study is contingent on confirmation of an adequate amount of tumor tissue.
- Patients with recurrent or metastatic disease resistant to platinum-based chemotherapy (defined as progression while on platinum-based chemotherapy given in the recurrent/metastatic setting). Pretreatment with cetuximab is allowed
- Measurable disease as determined by per RECIST criteria v1.1. If the only site of measurable disease is a previously irradiated lesion, documented progression of disease and a 4 week period since radiotherapy completion is required
- Adequate bone marrow function and organ function
Key exclusion criteria (5 listed)
- Patient has received previous treatment with any AKT, mTOR inhibitors or PI3K pathway inhibitors;
- Patient treated with more than one prior chemotherapy regimen for recurrent/metastatic disease
- Patient has symptomatic CNS metastases. Patients with asymptomatic CNS metastases may participate in this trial. The patient must have completed any prior local treatment for CNS metastases ≥ 28 days prior to the start of study treatment (including radiotherapy and/or surgery) and must have stable low dose of corticosteroid therapy;
- Patient has not recovered to ≤ grade 1 (except alopecia) from related side effects of any prior antineoplastic therapy
- Patient has any of the following cardiac abnormalities:symptomatic congestive heart failure, history of documented congestive heart failure (New York Heart Association functional classification III-IV), documented cardiomyopathy, Left Ventricular Ejection Fraction (LVEF) <50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO); myocardial infarction ≤ 6 months prior to enrolment, unstable angina pectoris, serious uncontrolled cardiac arrhythmia, symptomatic pericarditis, QTcF > 480 msec on the screening ECG (using the QTcF formula);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BuparlisibAlso: BKM120Buparlisib comes in gelatin capsules and is taken orally at a dose of 100 mg/day. | Drug | Buparlisib + weekly Paclitaxel |
| Buparlisib matching PlaceboBuparlisib matching placebo comes in gelatin capsules and is taken orally at a dose of 100 mg/day. | Drug | Buparlisib matching placebo + Paclitaxel |
| PaclitaxelPaclitaxel is an intravenous infusion that is given once every week in 80 mg/m^2. | Drug | Buparlisib + weekly Paclitaxel, Buparlisib matching placebo + Paclitaxel |
Primary outcome
Progression Free Survival (PFS) Per Investigator Assessment
Time frame: 4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years
PFS was defined as the time from the date of randomization to the date of the event, defined as the first radiologically documented disease progression per RECIST v. 1.1 or death due to any cause. If a patient has not progressed or died at the analysis cut-off date or when the patient receives further anti-neoplastic therapy, PFS was censored on the date of the last adequate tumor assessment before the earlier of the cut-off date or start of the further anti-neoplastic therapy date.
11 secondary outcomes
Overall Survival (OS)
Time frame: 4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years
Overall Response Rate (ORR) as Per Local Radiological Assessment
Time frame: 4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years
Time to Response (TTR) as Per Local Radiological Assessment
Time frame: 4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years
Disease Control Rate (DCR) as Per Local Radiological Assessment
Time frame: 4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years
Duration of Response (DoR) as Per Local Investigator
Time frame: 4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years
Health-related Quality of Life (HRQoL):Time to 10% Definitive Deterioration in the Global Health Status/Quality of Life Per EORTC-QLQ-C30
Time frame: Baseline, every 6 weeks starting from cycle 2 day 15 up to 3.5 years
Health-related Quality of Life (HRQoL):Time to 10% Definitive Deterioration in the Head and Neck Cancer Symptoms Scales for Pain, Speech Problems, Swallowing and Sense Problems Per EORTC-QLQ-HN35
Time frame: Baseline, every 6 weeks starting from cycle 2 day 15 up to 3.5 years
Plasma Concentration-time Profiles of BKM120 Pharmacokinetics (PK) for AUC0-24 and AUClast
Time frame: Time point(s) at which PK samples for Non-Compartmental analysis were collected were 0, 0.5,1,1.5, 2, 3, 4, 6, 9 and 24 hours at Cycle 1, Day 15
Plasma Concentration-time Profiles of BKM120 Pharmacokinetics (PK) for Cmax
Time frame: Time point(s) at which PK samples for Non-Compartmental analysis were collected were 0, 0.5,1,1.5, 2, 3, 4, 6, 9 and 24 hours at Cycle 1, Day 15
Plasma Concentration-time Profiles of BKM120 Pharmacokinetics (PK) for Tmax
Time frame: Time point(s) at which PK samples for Non-Compartmental analysis were collected were 0, 0.5,1,1.5, 2, 3, 4, 6, 9 and 24 hours at Cycle 1, Day 15
Plasma Concentration-time Profiles of BKM120 Pharmacokinetics (PK) for CL/F
Time frame: Time point(s) at which PK samples for Non-Compartmental analysis were collected were 0, 0.5,1,1.5, 2, 3, 4, 6, 9 and 24 hours at Cycle 1, Day 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39808408Desilets A, Lucas J, Licitra LF, Lu S, Tse A, Tang T, Dreyer K, He N, Birgerson LE, Faivre S, Soulieres D. Buparlisib and Paclitaxel in Patients with Head and Neck Squamous Cell Carcinoma: Immunogenomic Biomarkers of Efficacy from the BERIL-1 Study. Target Oncol. 2025 Mar;20(2):299-310. doi: 10.1007/s11523-024-01126-0. Epub 2025 Jan 14.
- Derived from this study: PubMed 28131786Soulieres D, Faivre S, Mesia R, Remenar E, Li SH, Karpenko A, Dechaphunkul A, Ochsenreither S, Kiss LA, Lin JC, Nagarkar R, Tamas L, Kim SB, Erfan J, Alyasova A, Kasper S, Barone C, Turri S, Chakravartty A, Chol M, Aimone P, Hirawat S, Licitra L. Buparlisib and paclitaxel in patients with platinum-pretreated recurrent or metastatic squamous cell carcinoma of the head and neck (BERIL-1): a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Oncol. 2017 Mar;18(3):323-335. doi: 10.1016/S1470-2045(17)30064-5. Epub 2017 Jan 26.
- Individual participant dataSharing planned: Undecided. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Not yet recruiting
Tumoral Versus Luminal Microbiome in Head and Neck Squamous Cell Carcinoma
Squamous Cell Cancer of Head and Neck (SCCHN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
58 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Buparlisib and Paclitaxel in people with Head and Neck Squamous Cell Carcinoma, run by Novartis Pharmaceuticals at 58 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in Italy, United States, India, Hungary, United Kingdom and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) Per Investigator Assessment (time frame: 4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01852292, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.