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

PHASE2TerminatedINTERVENTIONAL
Enrollment

157

Participants

Timeline

Start Date

October 1, 2013

Primary Completion Date

March 30, 2017

Study Completion Date

March 30, 2017

Conditions
Head and Neck Squamous Cell Carcinoma
Interventions
DRUG

Buparlisib

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

DRUG

Buparlisib matching Placebo

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

DRUG

Paclitaxel

Paclitaxel is an intravenous infusion that is given once every week in 80 mg/m\^2.

Trial Locations (58)

407

Novartis Investigative Site, Taichung

1082

Novartis Investigative Site, Budapest

1211

Novartis Investigative Site, Geneva

2065

Novartis Investigative Site, St Leonards

4031

Novartis Investigative Site, Basel

4400

Novartis Investigative Site, Nyíregyháza

10029

The Mount Sinai Hospital Dept of Oncology, New York

10126

Novartis Investigative Site, Torino

10330

Novartis Investigative Site, Bangkok

10700

Novartis Investigative Site, Bangkok

12203

Novartis Investigative Site, Berlin

15232

UPMC Cancer Centers BKM120H2201, Pittsburgh

20133

Novartis Investigative Site, Milan

20141

Novartis Investigative Site, Milan

20142

Novartis Investigative Site, Milan

28034

Novartis Investigative Site, Madrid

30174

Novartis Investigative Site, Venezia

30625

Novartis Investigative Site, Hanover

44106

University Hospitals Case Medical Center Univ. Hospitals of Cleveland, Cleveland

44805

Novartis Investigative Site, Saint-Herblain

45147

Novartis Investigative Site, Essen

50134

Novartis Investigative Site, Florence

63110

Washington U School of Medicine Center for Clinical Studies SC - BKM120H2201, St Louis

70421

Novartis Investigative Site, Tainan City

72703

Highlands Oncology Group, Fayetteville

83301

Novartis Investigative Site, Kaohsiung City

84131

Novartis Investigative Site, Salerno

90110

Novartis Investigative Site, Songkhla

90127

Novartis Investigative Site, Palermo

110005

Novartis Investigative Site, Dehli

188663

Novartis Investigative Site, Leningrad Region

197758

Novartis Investigative Site, Saint Petersburg

302017

Novartis Investigative Site, Jaipur

700160

Novartis Investigative Site, Kolkata

02215

Dana Farber Cancer Institute IRB, Boston

27599-7600

University of N.C. at Chapel Hill Lineberger Comp. Cancer Ctr., Chapel Hill

L8V 5C2

Novartis Investigative Site, Hamilton

H2L 4M1

Novartis Investigative Site, Montreal

H-1115

Novartis Investigative Site, Budapest

H-1122

Novartis Investigative Site, Budapest

422 004

Novartis Investigative Site, Nashik

695 011

Novartis Investigative Site, Kerala

400 012

Novartis Investigative Site, Mumbai

Unknown

Novartis Investigative Site, Dublin

Novartis Investigative Site, Nizhny Novgorod

00168

Novartis Investigative Site, Roma

277-8577

Novartis Investigative Site, Kashiwa

135 8550

Novartis Investigative Site, Koto-ku

105-8471

Novartis Investigative Site, Minato-ku

02-781

Novartis Investigative Site, Warsaw

05505

Novartis Investigative Site, Seoul

06591

Novartis Investigative Site, Seoul

08035

Novartis Investigative Site, Barcelona

08907

Novartis Investigative Site, L'Hospitalet de Llobregat

G12 0YN

Novartis Investigative Site, Glasgow

NW1 2PJ

Novartis Investigative Site, London

SE1 9RT

Novartis Investigative Site, London

M20 9BX

Novartis Investigative Site, Manchester

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY