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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01852292




Registration number
NCT01852292
Ethics application status
Date submitted
8/05/2013
Date registered
13/05/2013

Titles & IDs
Public title
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
Scientific 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)
Secondary ID [1] 0 0
2013-000744-26
Secondary ID [2] 0 0
CBKM120H2201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Squamous Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Buparlisib
Treatment: Drugs - Buparlisib matching Placebo
Treatment: Drugs - Paclitaxel

Experimental: Buparlisib + weekly 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.

Placebo comparator: 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.


Treatment: Drugs: Buparlisib
Buparlisib comes in gelatin capsules and is taken orally at a dose of 100 mg/day.

Treatment: Drugs: Buparlisib matching Placebo
Buparlisib matching placebo comes in gelatin capsules and is taken orally at a dose of 100 mg/day.

Treatment: Drugs: Paclitaxel
Paclitaxel is an intravenous infusion that is given once every week in 80 mg/m\^2.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) Per Investigator Assessment
Timepoint [1] 0 0
4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years
Secondary outcome [2] 0 0
Overall Response Rate (ORR) as Per Local Radiological Assessment
Timepoint [2] 0 0
4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years
Secondary outcome [3] 0 0
Time to Response (TTR) as Per Local Radiological Assessment
Timepoint [3] 0 0
4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years
Secondary outcome [4] 0 0
Disease Control Rate (DCR) as Per Local Radiological Assessment
Timepoint [4] 0 0
4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years
Secondary outcome [5] 0 0
Duration of Response (DoR) as Per Local Investigator
Timepoint [5] 0 0
4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years
Secondary outcome [6] 0 0
Health-related Quality of Life (HRQoL):Time to 10% Definitive Deterioration in the Global Health Status/Quality of Life Per EORTC-QLQ-C30
Timepoint [6] 0 0
Baseline, every 6 weeks starting from cycle 2 day 15 up to 3.5 years
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
Baseline, every 6 weeks starting from cycle 2 day 15 up to 3.5 years
Secondary outcome [8] 0 0
Plasma Concentration-time Profiles of BKM120 Pharmacokinetics (PK) for AUC0-24 and AUClast
Timepoint [8] 0 0
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
Secondary outcome [9] 0 0
Plasma Concentration-time Profiles of BKM120 Pharmacokinetics (PK) for Cmax
Timepoint [9] 0 0
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
Secondary outcome [10] 0 0
Plasma Concentration-time Profiles of BKM120 Pharmacokinetics (PK) for Tmax
Timepoint [10] 0 0
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
Secondary outcome [11] 0 0
Plasma Concentration-time Profiles of BKM120 Pharmacokinetics (PK) for CL/F
Timepoint [11] 0 0
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

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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);

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/03/2017
Sample size
Target
Accrual to date
Final
157
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Novartis Investigative Site - St Leonards
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Missouri
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Canada
State/province [9] 0 0
Quebec
Country [10] 0 0
France
State/province [10] 0 0
Saint Herblain cedex
Country [11] 0 0
Germany
State/province [11] 0 0
Berlin
Country [12] 0 0
Germany
State/province [12] 0 0
Essen
Country [13] 0 0
Germany
State/province [13] 0 0
Hannover
Country [14] 0 0
Hungary
State/province [14] 0 0
Budapest
Country [15] 0 0
Hungary
State/province [15] 0 0
Nyiregyhaza
Country [16] 0 0
India
State/province [16] 0 0
Maharashtra
Country [17] 0 0
India
State/province [17] 0 0
New Delhi
Country [18] 0 0
India
State/province [18] 0 0
Rajasthan
Country [19] 0 0
India
State/province [19] 0 0
West Bengal
Country [20] 0 0
India
State/province [20] 0 0
Kerala
Country [21] 0 0
India
State/province [21] 0 0
Mumbai
Country [22] 0 0
Ireland
State/province [22] 0 0
Dublin 4
Country [23] 0 0
Italy
State/province [23] 0 0
FI
Country [24] 0 0
Italy
State/province [24] 0 0
MI
Country [25] 0 0
Italy
State/province [25] 0 0
PA
Country [26] 0 0
Italy
State/province [26] 0 0
RM
Country [27] 0 0
Italy
State/province [27] 0 0
SA
Country [28] 0 0
Italy
State/province [28] 0 0
TO
Country [29] 0 0
Italy
State/province [29] 0 0
VE
Country [30] 0 0
Japan
State/province [30] 0 0
Chiba
Country [31] 0 0
Japan
State/province [31] 0 0
Tokyo
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Korea
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Seocho-gu
Country [34] 0 0
Poland
State/province [34] 0 0
Warszawa
Country [35] 0 0
Russian Federation
State/province [35] 0 0
Russia
Country [36] 0 0
Russian Federation
State/province [36] 0 0
Nizhniy Novgorod
Country [37] 0 0
Russian Federation
State/province [37] 0 0
St. Petersburg
Country [38] 0 0
Spain
State/province [38] 0 0
Catalunya
Country [39] 0 0
Spain
State/province [39] 0 0
Madrid
Country [40] 0 0
Switzerland
State/province [40] 0 0
Basel
Country [41] 0 0
Switzerland
State/province [41] 0 0
Genève
Country [42] 0 0
Taiwan
State/province [42] 0 0
Taiwan ROC
Country [43] 0 0
Taiwan
State/province [43] 0 0
Kaohsiung City
Country [44] 0 0
Taiwan
State/province [44] 0 0
Taichung City
Country [45] 0 0
Thailand
State/province [45] 0 0
Hat Yai
Country [46] 0 0
Thailand
State/province [46] 0 0
Bangkok
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Scotland
Country [48] 0 0
United Kingdom
State/province [48] 0 0
London
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
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


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01852292