NCT01870726 - Safety and Efficacy of INC280 and Buparlisib (BKM120) in Patients With Recurrent Glioblastoma | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 9, 2014

Primary Completion Date

December 23, 2016

Study Completion Date

December 23, 2016

Conditions

c-MET Inhibitor; PI3K Inhibitor, PTEN Mutations, Homozygous Del. of PTEN or PTEN Neg. by IHC, c-Met Ampli. by FISH, INC280, BKM120, Buparlisib; Recurrent GBM

Interventions

DRUG

INC280

"Phase Ib: INC280 was given at the starting dose of 200mg capsules twice daily with escalation to higher strengths.~Phase II: INC280 was given at the dose of 400mg (tablets) twice daily."

DRUG

Buparlisib

Buparlisib was given at the starting dose of 50mg once daily with escalation to higher strengths.

Trial Locations (13)

9007

Novartis Investigative Site, Sankt Gallen

10032

Columbia University Medical Center- New York Presbyterian Dept of Oncology, New York

27710

Duke University Medical Center Duke - Baker, Durham

28041

Novartis Investigative Site, Madrid

53105

Novartis Investigative Site, Bonn

69120

Novartis Investigative Site, Heidelberg

72076

Novartis Investigative Site, Tübingen

77030

University of Texas MD Anderson Cancer Center SC-3, Houston

90033

Memorial Sloan Kettering Cancer Center Neurology, New York

02215

Dana Farber Cancer Institute SC, Boston

3075EA

ErasmusMC Cancer Institute - Neurooncology, RM G3-55, Rotterdam

3508 GA

University Medical Center Utrecht, Rm Q05.4.300, P.O. Box 85500, Utrecht

08035

Novartis Investigative Site, Barcelona