NCT01934361 - Phase Ib/II Study of Buparlisib Plus Carboplatin or Lomustine in Patients With Recurrent Glioblastoma Multiforme | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

July 7, 2016

Study Completion Date

July 7, 2016

Conditions

Recurrent Glioblastoma Multiforme

Interventions

DRUG

buparlisib

Buparlisib administered orally on a continuous daily schedule. Buparlisib is manufactured as 10mg and 50mg hard gelatin capsules.

DRUG

carboplatin

Carboplatin intravenous infusion will be administered at a dose of AUC 5 in a 21 day cycle (every 3 weeks).

DRUG

lomustine

Lomustine will be administered as a single oral dose of 100 mg/m² every 6 weeks in a 42 day cycles.

DRUG

placebo

Placebo will be administered orally on a continuous QD dosing schedule for cycles of 42 days. Buparlisib matching placebo is manufactured as 10 mg and 50 mg hard gelatin capsules.

Trial Locations (14)

3000

Novartis Investigative Site, Leuven

3050

Novartis Investigative Site, Parkville

3084

Novartis Investigative Site, Heidelberg

13885

Novartis Investigative Site, Marseille

44805

Novartis Investigative Site, Saint-Herblain

60611

Northwestern University, Chicago

72703

Highlands Oncology Group, Fayetteville

75651

Novartis Investigative Site, Paris

77030

MD Anderson Cancer Center/University of Texas, Houston

85013

Barrow Neurological Insitute St. Joseph's Hospital, Phoenix

02215

Dana Farber Cancer Institute, Boston

M5G 1Z6

Novartis Investigative Site, Toronto

08036

Novartis Investigative Site, Barcelona

08907

Novartis Investigative Site, L'Hospitalet de Llobregat