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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000744-26 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buparlisib | Drug | Buparlisib comes in gelatin capsules and is taken orally at a dose of 100 mg/day. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | United States | ||
| Dana Farber Cancer Institute IRB |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39808408 | Derived | 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. | |
| 28131786 |
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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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158 patients randomized in a 1:1 ratio to treatment with buparlisib plus paclitaxel or placebo plus paclitaxel; stratification: number of prior lines of treatment in the recurrent/metastatic setting (1 vs.2) & region of Investigator site (North America vs. Rest of the World). In this study, Not Completed = Discontinued study treatment per Protocol
Planned: 150; Analyzed: 158. Patients were randomized to receive treatment with buparlisib 100 mg daily (n=79) or placebo (n=79) in combination with paclitaxel.
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| ID | Title | Description |
|---|---|---|
| FG000 | Buparlisib + Weekly Paclitaxel | Patients who were randomized to this arm on a 1:1 randomization, took buparlisib 100 mg daily and weekly paclitaxel. |
| FG001 | Buparlisib Matching Placebo + Paclitaxel |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 22, 2016 | Mar 30, 2018 |
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| Buparlisib matching Placebo | Drug | Buparlisib matching placebo comes in gelatin capsules and is taken orally at a dose of 100 mg/day. |
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| Paclitaxel | Drug | Paclitaxel is an intravenous infusion that is given once every week in 80 mg/m^2. |
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| 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). |
| 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). | 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. | 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 . | 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. | 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. | 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). | 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. | 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. | 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. | 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 |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Washington U School of Medicine Center for Clinical Studies SC - BKM120H2201 | St Louis | Missouri | 63110 | United States |
| The Mount Sinai Hospital Dept of Oncology | New York | New York | 10029 | United States |
| University of N.C. at Chapel Hill Lineberger Comp. Cancer Ctr. | Chapel Hill | North Carolina | 27599-7600 | United States |
| University Hospitals Case Medical Center Univ. Hospitals of Cleveland | Cleveland | Ohio | 44106 | United States |
| UPMC Cancer Centers BKM120H2201 | Pittsburgh | Pennsylvania | 15232 | United States |
| Novartis Investigative Site | St Leonards | New South Wales | 2065 | Australia |
| Novartis Investigative Site | Hamilton | Ontario | L8V 5C2 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H2L 4M1 | Canada |
| Novartis Investigative Site | Saint-Herblain | 44805 | France |
| Novartis Investigative Site | Berlin | 12203 | Germany |
| Novartis Investigative Site | Essen | 45147 | Germany |
| Novartis Investigative Site | Hanover | 30625 | Germany |
| Novartis Investigative Site | Budapest | 1082 | Hungary |
| Novartis Investigative Site | Budapest | H-1115 | Hungary |
| Novartis Investigative Site | Budapest | H-1122 | Hungary |
| Novartis Investigative Site | NyÃregyháza | 4400 | Hungary |
| Novartis Investigative Site | Nashik | Maharashtra | 422 004 | India |
| Novartis Investigative Site | Dehli | New Delhi | 110005 | India |
| Novartis Investigative Site | Jaipur | Rajasthan | 302017 | India |
| Novartis Investigative Site | Kolkata | West Bengal | 700160 | India |
| Novartis Investigative Site | Kerala | 695 011 | India |
| Novartis Investigative Site | Mumbai | 400 012 | India |
| Novartis Investigative Site | Dublin | Ireland |
| Novartis Investigative Site | Florence | FI | 50134 | Italy |
| Novartis Investigative Site | Milan | MI | 20133 | Italy |
| Novartis Investigative Site | Milan | MI | 20141 | Italy |
| Novartis Investigative Site | Milan | MI | 20142 | Italy |
| Novartis Investigative Site | Palermo | PA | 90127 | Italy |
| Novartis Investigative Site | Roma | RM | 00168 | Italy |
| Novartis Investigative Site | Salerno | SA | 84131 | Italy |
| Novartis Investigative Site | Torino | TO | 10126 | Italy |
| Novartis Investigative Site | Venezia | VE | 30174 | Italy |
| Novartis Investigative Site | Kashiwa | Chiba | 277-8577 | Japan |
| Novartis Investigative Site | Koto-ku | Tokyo | 135 8550 | Japan |
| Novartis Investigative Site | Minato-ku | Tokyo | 105-8471 | Japan |
| Novartis Investigative Site | Warsaw | 02-781 | Poland |
| Novartis Investigative Site | Leningrad Region | Russia | 188663 | Russia |
| Novartis Investigative Site | Nizhny Novgorod | Russia |
| Novartis Investigative Site | Saint Petersburg | 197758 | Russia |
| Novartis Investigative Site | Seoul | Korea | 05505 | South Korea |
| Novartis Investigative Site | Seoul | Seocho-gu | 06591 | South Korea |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | L'Hospitalet de Llobregat | Catalonia | 08907 | Spain |
| Novartis Investigative Site | Madrid | 28034 | Spain |
| Novartis Investigative Site | Basel | 4031 | Switzerland |
| Novartis Investigative Site | Geneva | 1211 | Switzerland |
| Novartis Investigative Site | Tainan | Taiwan ROC | 70421 | Taiwan |
| Novartis Investigative Site | Kaohsiung City | 83301 | Taiwan |
| Novartis Investigative Site | Taichung | 407 | Taiwan |
| Novartis Investigative Site | Songkhla | Hat Yai | 90110 | Thailand |
| Novartis Investigative Site | Bangkok | 10330 | Thailand |
| Novartis Investigative Site | Bangkok | 10700 | Thailand |
| Novartis Investigative Site | Glasgow | Scotland | G12 0YN | United Kingdom |
| Novartis Investigative Site | London | NW1 2PJ | United Kingdom |
| Novartis Investigative Site | London | SE1 9RT | United Kingdom |
| Novartis Investigative Site | Manchester | M20 9BX | United Kingdom |
| Soulieres 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. |
Patients who were randomized to this arm on a 1:1 randomization, took buparlisib matching placebo 100 mg daily and weekly paclitaxel.
| COMPLETED |
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| NOT COMPLETED |
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The Full analysis set (FAS) includes all patients who were randomized to study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Buparlisib + Paclitaxel | Patients who were randomized to this arm on a 1:1 randomization, took buparlisib 100 mg daily and paclitaxel 80 mg/m^2 weekly. |
| BG001 | Buparlisib Matching Placebo + Paclitaxel | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | The Full analysis set (FAS) includes all patients who were randomized to study treatment. | Mean | Standard Deviation | Years |
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| Sex: Female, Male | The Full analysis set (FAS) includes all patients who were randomized to study treatment. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | The Full analysis set (FAS) includes all patients who were randomized to study treatment. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | The Full analysis set (FAS) includes all patients who were randomized to study treatment. | Posted | Median | 95% Confidence Interval | months | 4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years |
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| Secondary | 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. | The Full analysis set (FAS) includes all patients who were randomized to study treatment. | Posted | Median | 95% Confidence Interval | months | 4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years |
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| Secondary | 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). | The Full analysis set (FAS) includes all patients who were randomized to study treatment. | Posted | Median | 95% Confidence Interval | Percentage of participants | 4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years |
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| Secondary | 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). | The Full analysis set (FAS) includes all patients who were randomized to study treatment. | Posted | Median | Full Range | months | 4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years |
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| Secondary | 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. | The Full analysis set (FAS) includes all patients who were randomized to study treatment. | Posted | Number | 95% Confidence Interval | Percentage of participants | 4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years |
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| Secondary | 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 . | The Full analysis set (FAS) includes all patients who were randomized to study treatment. | Posted | Median | Full Range | months | 4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years |
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| Secondary | 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. | The Full analysis set (FAS) includes all patients who were randomized to study treatment. | Posted | Median | 95% Confidence Interval | months | Baseline, every 6 weeks starting from cycle 2 day 15 up to 3.5 years |
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| Secondary | 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. | The Full analysis set (FAS) includes all patients who were randomized to study treatment. | Posted | Median | 95% Confidence Interval | Months | Baseline, every 6 weeks starting from cycle 2 day 15 up to 3.5 years |
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| Secondary | 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). | Full Sampling Pharmacokinetic Analysis Set (FPAS): All pts in PAS who received planned dose of buparlisib every day for last consecutive 7 days before full PK profile assessment on C1D15, didn't vomit within 4 hours of buparlisib dosing, had at least 1 dose of paclitaxel before collection of PK sample for PK profile & had evaluable full PK profile | Posted | Median | Full Range | ng*hr/mL | 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 |
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| Secondary | Plasma Concentration-time Profiles of BKM120 Pharmacokinetics (PK) for Cmax | To characterize the pharmacokinetics of buparlisib given in combination with paclitaxel for Cmax. | Full Sampling Pharmacokinetic Analysis Set (FPAS): All pts in PAS who received planned dose of buparlisib every day for last consecutive 7 days before full PK profile assessment on C1D15, didn't vomit within 4 hours of buparlisib dosing, had at least 1 dose of paclitaxel before collection of PK sample for PK profile & had evaluable full PK profile | Posted | Median | Full Range | ng/mL | 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 |
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| Secondary | Plasma Concentration-time Profiles of BKM120 Pharmacokinetics (PK) for Tmax | To characterize the pharmacokinetics of buparlisib given in combination with paclitaxel for Tmax. | Full Sampling Pharmacokinetic Analysis Set (FPAS): All pts in PAS who received planned dose of buparlisib every day for last consecutive 7 days before full PK profile assessment on C1D15, didn't vomit within 4 hours of buparlisib dosing, had at least 1 dose of paclitaxel before collection of PK sample for PK profile & had evaluable full PK profile | Posted | Median | Full Range | hour (hr) | 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 |
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| Secondary | 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. | Full Sampling Pharmacokinetic Analysis Set (FPAS): All pts in PAS who received planned dose of buparlisib every day for last consecutive 7 days before full PK profile assessment on C1D15, didn't vomit within 4 hours of buparlisib dosing, had at least 1 dose of paclitaxel before collection of PK sample for PK profile & had evaluable full PK profile | Posted | Median | Full Range | L/hr | 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 |
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Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt & had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Buparlisib + Paclitaxel | Patients who were randomized to this arm on a 1:1 randomization, took buparlisib 100 mg daily and paclitaxel 80 mg/m^2 weekly. | 16 | 76 | 43 | 76 | 76 | 76 |
| EG001 | Buparlisib Matching Placebo + Paclitaxel | 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. | 17 | 78 | 37 | 78 | 75 | 78 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypercalcaemia of malignancy | Endocrine disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Blindness | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Aorto-oesophageal fistula | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Oesophageal obstruction | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Oral cavity fistula | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Candida sepsis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Chest wall abscess | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Post procedural discharge | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Post procedural fistula | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Tumour invasion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Intracranial pressure increased | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Ischaemic cerebral infarction | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Paraplegia | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Device connection issue | Product Issues | MedDRA (19.1) | Systematic Assessment |
| |
| Acute psychosis | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Upper airway obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Arterial rupture | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Catarrh | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | novartis.email@novartis.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Aug 30, 2016 | Mar 30, 2018 | Prot_001.pdf |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D009362 | Neoplasm Metastasis |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
Not provided
Not provided
| ID | Term |
|---|---|
| C571178 | NVP-BKM120 |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Male |
|
| East Asian |
|
| Southeast Asian |
|
| South Asian |
|
| Russian |
|
| Mixed ethnicity |
|
| Not reported |
|
| Unknown |
|
| Other |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
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. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|