A Phase Ib/II Study of BYL719 and Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

179

Participants

Timeline

Start Date

November 12, 2012

Primary Completion Date

September 16, 2016

Study Completion Date

September 16, 2016

Conditions
Recurrent Head and Neck Squamous Cell CarcinomaMetastatic Head and Neck Squamous Cell Carcinoma
Interventions
DRUG

BYL719 as film-coated (FC) whole tablets

Oral alpha-specific PI3K inhibitor

DRUG

BYL719 as dispersible tablets (DT)

New formulation of the oral alpha-specific PI3K inhibitor

BIOLOGICAL

cetuximab

Recombinant chimeric monoclonal antibody driven against EGFR

DRUG

BYL719 drink suspension

Oral alpha-specific PI3K inhibitor

Trial Locations (29)

3000

Novartis Investigative Site, Melbourne

5800

Novartis Investigative Site, Maastricht

6150

Novartis Investigative Site, Murdoch

10017

Novartis Investigative Site, New York

10029

Novartis Investigative Site, New York

10048

Novartis Investigative Site, Taipei

19104

Novartis Investigative Site, Philadelphia

29425

Novartis Investigative Site, Charleston

30322

Novartis Investigative Site, Atlanta

31059

Novartis Investigative Site, Toulouse

32224

Novartis Investigative Site, Jacksonville

32806

Novartis Investigative Site, Orlando

33305

Novartis Investigative Site, Kuei-Shan Chiang

37232

Novartis Investigative Site, Nashville

63110

Novartis Investigative Site, St Louis

69373

Novartis Investigative Site, Lyon

70421

Novartis Investigative Site, Tainan City

77030

Novartis Investigative Site, Houston

80045

Novartis Investigative Site, Aurora

94101

Novartis Investigative Site, San Francisco

95817

Novartis Investigative Site, Sacramento

169610

Novartis Investigative Site, Singapore

02114

Novartis Investigative Site, Boston

M5G 2M9

Novartis Investigative Site, Toronto

Unknown

Novartis Investigative Site, Shatin, New Territories

6500 HB

Novartis Investigative Site, Nijmegen

03080

Novartis Investigative Site, Seoul

06351

Novartis Investigative Site, Seoul

03722

Novartis Investigative Site, Seoul

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY