A Phase I/II Study of BEZ235 in Patients With Advanced Solid Malignancies Enriched by Patients With Advanced Breast Cancer
Status:
Completed
Trial end date:
2013-01-08
Target enrollment:
Participant gender:
Summary
This is a first-in-human, phase I/Ib clinical research study with BEZ235, an inhibitor of
phosphatidylinositol 3'-kinase (PI3K). The study consists of a dose escalation part followed
by a safety dose expansion part:
Dose escalation part (advanced solid tumors, including patients with breast cancer being
treated with trastuzumab):
Patients receive oral BEZ235 once daily on days 1-28 of the first course. Courses will repeat
every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of at least 3 patients receive escalating doses of BEZ235, as single agent or in
combination with trastuzumab, until the maximum tolerated dose (MTD) is determined. The MTD
is defined as the dose expected to produce during the first course of treatment dose-limiting
toxicity in 33% of patients.
Once the MTD has been defined, the safety expansion parts of the trial will be opened for
enrollment.
Safety dose expansion part (advanced solid tumors, including patients with breast cancer
being treated with trastuzumab):
Patients will be treated with BEZ235, as single agent or in combination with trastuzumab,
given at the MTD, once daily. Treatment of patients will continue until disease progression
or occurrence of unacceptable side effects.