A Phase I/II Study of BEZ235 in Patients With Advanced Solid Malignancies Enriched by Patients With Advanced Breast Cancer

A Phase I/II Study of BEZ235 in Patients With Advanced Solid Malignancies Enriched by Patients With Advanced Breast Cancer

Solid Tumors

Ongoing, but not recruiting

1

Start Date 12/15/2006

Age of Trial (yrs) 17.9

Gleevec-resistant

mTOR inhibitor PI3K inhibitor

Block KIT Signal Path

GIST not specified. GIST patient enrollment unknown.

CBEZ235A2101

Novartis

Novartis

862-778-8300

Oral

This is a first-in-man, phase I/II clinical research study with BEZ235, an inhibitor of phosphatidylinositol 3'-kinase (PI3K). The study consists of a Phase I dose escalation part followed by a safety expansion part and a Phase II expansion part:

Phase I dose escalation part (advanced solid tumors):

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 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 and efficacy expansion parts of the trial will be opened for enrollment.

Phase I safety expansion part (advanced solid tumors):

Patients will be treated with BEZ235, given at the MTD, once daily. Treatment of patients will continue until disease progression or occurrence of unacceptable side effects.

Phase II expansion part (advanced breast cancer):

Patients will be treated with BEZ235, given at the MTD, once daily. Treatment of patients will continue until disease progression or occurrence of unacceptable side effects.

An effort will be made to enrich the trial population with Cowden Syndrome patients with advanced solid malignancies.