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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01852292
First received: May 8, 2013
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Platinum Pre-treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma.
Drug: Paclitaxel
Drug: Buparlisib
Drug: Buparlisib Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: at 4 weeks after study treatment start ] [ Designated as safety issue: No ]
    To estimate the efficacy of buparlisib in combination with paclitaxel


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: every 3 months for 2 years ] [ Designated as safety issue: No ]
    To assess the efficacy of the combination with paclitaxel in this patient population in terms of overall survival

  • Safety and Tolerability - frequency and severity of adverse events [ Time Frame: on an ongoing basis for a maximum of 2 years. ] [ Designated as safety issue: Yes ]
    To assess the safety and tolerability of buparlisib in combination with paclitaxel in this patient population

  • Overall Response Rate (ORR) [ Time Frame: at 4 weeks after study treatment start and every 6 weeks afterwards until 2 years. ] [ Designated as safety issue: No ]
  • Time to Response (TTR) [ Time Frame: at 4 weeks after study treatment start and every 6 weeks afterwards until 2 years. ] [ Designated as safety issue: No ]
  • Disease Control Rate (DCR) [ Time Frame: at 4 weeks after study treatment start and every 6 weeks afterwards until 2 years. ] [ Designated as safety issue: No ]
  • Duration of Response (DoR) [ Time Frame: at 4 weeks after study treatment start and every 6 weeks afterwards until 2 years. ] [ Designated as safety issue: No ]
  • Change from baseline in the global health status/QOL and pain scale scores of the EORTC QLQ-C30 and QLQ-HN35 [ Time Frame: baseline and every 6 weeks after randomization for 2 years . ] [ Designated as safety issue: No ]
    Percentage of change

  • Time to definitive 10% deterioration in the global health status/QOL (quality of life) [ Time Frame: baseline, and every 6 weeks after randomization for maximum for 2 years ] [ Designated as safety issue: No ]
  • Pain scale scores of the EORTC QLQ-C30 and QLQ-HN35 [ Time Frame: baseline, and every 6 weeks after randomization for maximum for 2 years ] [ Designated as safety issue: No ]
  • PK Sampling [ Time Frame: Cycle 1, Day1 of ecah cycle until Cycle 6 ] [ Designated as safety issue: No ]
    To characterize the pharmacokinetics of buparlisib given in combination with paclitaxel


Estimated Enrollment: 150
Study Start Date: October 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Buparlisib + Paclitaxel
buparlisib (BKM120) 100 mg daily + Paclitaxel
Drug: Paclitaxel
Other Name: This is a combination trial, all patients will be tretaed with paclitaxel +/- buparlisib.
Drug: Buparlisib
Other Name: BKM120
Placebo Comparator: Buparlisib matching placebo + Paclitaxel
buparlisib matching placebo
Drug: Paclitaxel
Other Name: This is a combination trial, all patients will be tretaed with paclitaxel +/- buparlisib.
Drug: Buparlisib Placebo

Detailed Description:

The primary endpoint is PFS and the key secondary endpoint is Overall Survival.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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);
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01852292

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Hide Study Locations
Locations
United States, Arkansas
Highlands Oncology Group Dept of Highlands Oncology Grp Recruiting
Fayetteville, Arkansas, United States, 72703
Contact: Curtis R. Randolph    +1 479 872 8130    aconway@hogonc.com   
Principal Investigator: Joseph Thaddeus Beck         
United States, California
UCLA Medical Center Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Sandra Hernandez    310-825-4493    shernandez@mednet.ucla.edu   
Principal Investigator: Fairooz Kabbinavar         
United States, Massachusetts
Dana Farber Cancer Institute BKM120H2201 Recruiting
Boston, Massachusetts, United States
Contact: Pam Roth    617-582-8039    proth@partners.org   
Principal Investigator: Jochen Lorch         
United States, Missouri
Washington U School of Medicine, Center for Clinical Studies SC - BKM120H2201 Not yet recruiting
St. Louis, Missouri, United States, 63110
Contact: Erin Axley    314-747-8092    eaxley@dom.wustl.edu   
Principal Investigator: Douglas Adkins         
United States, New York
Mount Sinai School of Medicine Dept of Oncology Recruiting
New York, New York, United States, 10029
Contact: Nancy Pamela Lowe    212 241 5253    Nancy.lowe@mssm.edu   
Principal Investigator: Marshall Posner         
United States, North Carolina
University of N.C. at Chapel Hill Lineberger Comp. Cancer Ctr. Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Ayoola Aboyade-Cole    919-843-3875    aacole@med.unc.edu   
Principal Investigator: Juneko Grilley-Olson         
United States, Ohio
University Hospitals Case Medical Center Univ. Hospitals of Cleveland Recruiting
Cleveland, Ohio, United States, 44106
Contact: Simona Pasca    216-844-5586    simona.pasca@uhhospitals.org   
Principal Investigator: Michael Gibson         
United States, Pennsylvania
Fox Chase Cancer Center BKM120H2201 Withdrawn
Philadelphia, Pennsylvania, United States, 19111-2497
UPMC Cancer Centers BKM120H2201 Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Amy O'Sullivan    412-623-4126    osullivanal@upmc.edu   
Principal Investigator: Julie Bauman         
United States, Texas
University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(2) Recruiting
Dallas, Texas, United States, 75390-8527
Contact: Melana Lindsay    214-648-1988    melana.lindsay@utsouthwestern.edu   
Principal Investigator: Saad A. Khan         
Australia, New South Wales
Novartis Investigative Site Recruiting
St. Leonards, New South Wales, Australia, 2065
Canada, Ontario
Novartis Investigative Site Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Novartis Investigative Site Recruiting
London, Ontario, Canada, N6A 4L6
Canada, Quebec
Novartis Investigative Site Recruiting
Montreal, Quebec, Canada, H2L 4M1
France
Novartis Investigative Site Not yet recruiting
Besancon Cedex, France, 25030
Novartis Investigative Site Not yet recruiting
Bordeaux Cedex, France, 33075
Novartis Investigative Site Not yet recruiting
Clichy, France, 92110
Novartis Investigative Site Not yet recruiting
La Chaussée St Victor, France, 41260
Novartis Investigative Site Not yet recruiting
Lyon Cedex, France, 69373
Novartis Investigative Site Not yet recruiting
Nice Cedex 2, France, 06189
Novartis Investigative Site Not yet recruiting
Saint Herblain cedex, France, 44805
Novartis Investigative Site Not yet recruiting
Toulouse Cedex 9, France, 31059
Novartis Investigative Site Not yet recruiting
Vandoeuvre-Les-Nancy Cede, France, 54511
Novartis Investigative Site Not yet recruiting
Villejuif Cedex, France, 94805
Germany
Novartis Investigative Site Recruiting
Berlin, Germany, 12200
Novartis Investigative Site Recruiting
Essen, Germany, 45147
Novartis Investigative Site Recruiting
Hannover, Germany, 30625
Novartis Investigative Site Recruiting
Leipzig, Germany, 04103
Hungary
Novartis Investigative Site Recruiting
Budapest, Hungary, H-1122
Novartis Investigative Site Recruiting
Budapest, Hungary, H-1115
Novartis Investigative Site Recruiting
Budapest, Hungary, 1082
Novartis Investigative Site Recruiting
Nyiregyhaza, Hungary, 4400
India
Novartis Investigative Site Not yet recruiting
Dehli, New Delhi, India, 110005
Novartis Investigative Site Recruiting
Jaipur, Rajasthan, India, 302017
Novartis Investigative Site Recruiting
Kolkata, West Bengal, India, 700 156
Novartis Investigative Site Not yet recruiting
Kerala, India, 695 011
Novartis Investigative Site Not yet recruiting
Mumbai, India, 400 012
Ireland
Novartis Investigative Site Not yet recruiting
Cork, Ireland
Novartis Investigative Site Recruiting
Dublin 4, Ireland
Italy
Novartis Investigative Site Recruiting
Bologna, BO, Italy, 40139
Novartis Investigative Site Not yet recruiting
Cuneo, CN, Italy, 12100
Novartis Investigative Site Recruiting
Firenze, FI, Italy, 50134
Novartis Investigative Site Not yet recruiting
Milano, MI, Italy, 20141
Novartis Investigative Site Recruiting
Milano, MI, Italy, 20142
Novartis Investigative Site Recruiting
Milano, MI, Italy, 20133
Novartis Investigative Site Recruiting
Palermo, PA, Italy, 90127
Novartis Investigative Site Not yet recruiting
Reggio Emilia, RE, Italy, 42123
Novartis Investigative Site Recruiting
Roma, RM, Italy, 00168
Novartis Investigative Site Recruiting
Salerno, SA, Italy, 84131
Novartis Investigative Site Not yet recruiting
Torino, TO, Italy, 10126
Novartis Investigative Site Recruiting
Venezia, VE, Italy, 30174
Japan
Novartis Investigative Site Recruiting
Kashiwa, Chiba, Japan
Novartis Investigative Site Recruiting
Minato-ku, Tokyo, Japan, 105-8471
Korea, Republic of
Novartis Investigative Site Recruiting
Seoul, Korea, Republic of, 738-736
Novartis Investigative Site Recruiting
Seoul, Korea, Republic of, 137-701
Poland
Novartis Investigative Site Not yet recruiting
Warszawa, Poland, 02-781
Russian Federation
Novartis Investigative Site Recruiting
Leningrad Region, Russia, Russian Federation, 188663
Novartis Investigative Site Not yet recruiting
Nizhniy Novgorod, Russia, Russian Federation
Novartis Investigative Site Not yet recruiting
St. Petersburg, Russian Federation, 197758
Spain
Novartis Investigative Site Recruiting
Salamanca, Castilla y Leon, Spain, 37007
Novartis Investigative Site Recruiting
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site Recruiting
Hospitalet de LLobregat, Catalunya, Spain, 08907
Novartis Investigative Site Not yet recruiting
Madrid, Spain, 28034
Switzerland
Novartis Investigative Site Recruiting
Basel, Switzerland, 4031
Novartis Investigative Site Recruiting
Genève, Switzerland, 1211
Taiwan
Novartis Investigative Site Recruiting
Tainan 704, Taiwan ROC, Taiwan
Novartis Investigative Site Recruiting
Niaosong Township, Taiwan, 83301
Novartis Investigative Site Recruiting
Taichung City, Taiwan, 407
Thailand
Novartis Investigative Site Recruiting
Bangkok, Thailand, 10330
Novartis Investigative Site Not yet recruiting
Bangkok, Thailand, 10700
Novartis Investigative Site Recruiting
Songkla, Thailand, 90110
United Kingdom
Novartis Investigative Site Recruiting
Glasgow, United Kingdom, G12 0YN
Novartis Investigative Site Recruiting
London, United Kingdom, SE1 9RT
Novartis Investigative Site Recruiting
London, United Kingdom, NW1 2PJ
Novartis Investigative Site Recruiting
Manchester, United Kingdom, M20 9BX
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01852292     History of Changes
Other Study ID Numbers: CBKM120H2201
Study First Received: May 8, 2013
Last Updated: June 10, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration
France: ANSM
Germany: BfarM
Hungary: National Institute of Pharmacy
Italy: AIFA
Japan: Pharmaceuticals and Medical Devices Agency
Poland: Ministry of Health
Russia: Ministry of Health of the Russian Federation
South Korea: Food and Drug Administration
Spain: Agency of Medecines & Health Products
Switzerland: Swissmedic
Taiwan: Center for Drug Evaluation
Thailand: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
India: Indian Council of Medical Research
Ireland:Health & Safety Authority

Keywords provided by Novartis:
Head and neck squamous cell carcinoma,
recurrent,
metastatic,
BKM120

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Carcinoma
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 29, 2014