The purpose of the trial is to determine the maximum tolerated dose (MTD) of BEZ235 and BKM120 in combination with weekly paclitaxel and weekly paclitaxel/trastuzumab.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Novartis Investigative Site
Brussels, Belgium
Novartis Investigative Site
Brussels, Belgium
Novartis Investigative Site
Wilrijk, Belgium
Novartis Investigative Site
Cologne, Germany
Incidence of Dose limiting toxicities during the first cycle of treatment.
Time frame: First treatment cycle (4 weeks)
Incidence of safety events during the whole treatment period (until progression of disease).
Time frame: From start of treatment until disease progression
pharmacokinetics of BEZ235, BKM120 and paclitaxel given in combination, on Day 1, 8 and 22.
Time frame: First treatment cycle (4 weeks)
Treatment efficacy (response to treatment according to RECIST criteria)
Time frame: From start of treatment until disease progression
Impact of treatment on biomarkers of Pi3 Kinase pathway (analyses of skin biopsies, circulating markers)
Time frame: From start of treatment until disease progression
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Novartis Investigative Site
Essen, Germany
Novartis Investigative Site
Amsterdam, Netherlands
Novartis Investigative Site
Seville, Andalusia, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Chur, Switzerland
Novartis Investigative Site
Sankt Gallen, Switzerland