NCT01132664 - Phase 1b/2 Study of BKM120 Plus Trastuzumab in Patients With HER2-positive Breast Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

May 31, 2010

Primary Completion Date

August 31, 2014

Study Completion Date

August 31, 2014

Conditions

Metastatic Breast CancerHER2+ Breast Cancer

Interventions

DRUG

BKM120

Buparlisib (BKM120) is the investigational drug. Burparlisib was supplied as 10 mg and 50 mg hard gelatin capsules. Buparlisib was dosed on a flat scale of mg/day and not adjusted to body weight or body surface area. Buparlisib capsules were packaged in high density polyethylene bottles with a plastic child resistant closure.

DRUG

Trastuzumab

Trastuzumab was used in this study according to the local regulations in each participating country. A loading dose (4 mg/kg) of trastuzumab was administered (if required as assessed by the principal Investigator based on the timing of the last trastuzumab dose prior to enrollment) on Day -7 over 90 minutes, followed by weekly intravenous infusion of 2 mg/kg maintenance doses from Day 1 of Cycle 1 (over 30 minutes if the previous infusion was well tolerated).

DRUG

Capecitabine

1000 mg/m2 twice a day from day 1 to Day 14 of a 21-day cycle.

Trial Locations (21)

2610

Novartis Investigative Site, Wilrijk

4000

Novartis Investigative Site, Liège

10003

Beth Israel Medical Center BIMC, New York

33612

H. Lee Moffitt Cancer Center & Research Institute, Tampa

37203

Sarah Cannon Research Institute Sarah Cannon Cancer Center SC, Nashville

41100

Novartis Investigative Site, Modena

44805

Novartis Investigative Site, Saint-Herblain Cédex

46010

Novartis Investigative Site, Valencia

48201

Karmanos Cancer Institute Dept.of KarmanosCancerInst (6), Detroit

62100

Novartis Investigative Site, Macerata

63110

Washington University School Of Medicine-Siteman Cancer Ctr WA Siteman, St Louis

69373

Novartis Investigative Site, Lyon

72703

Highlands Oncology Group Dept of Highlands Oncology Grp, Fayetteville

35294-0006

University of Alabama at Birmingham/ Kirklin Clinic Univ AL - PI, Birmingham

09134

Novartis Investigative Site, Cagliari

05100

Novartis Investigative Site, Terni

08035

Novartis Investigative Site, Barcelona

08907

Novartis Investigative Site, L'Hospitalet de Llobregat

BN2 5BE

Novartis Investigative Site, Brighton

NG5 1PB

Novartis Investigative Site, Nottingham

OX3 7LJ

Novartis Investigative Site, Oxford