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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase I/II, Multi-center, Open-label Study of BEZ235, Administered Orally on a Continuous Daily Dosing Schedule in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Br

Brief 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.


Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome:

  • determine the maximum Tolerated Dose (MTD) of BEZ235 as single agent and in combination with trastuzumab (Dose escalation part) [ Time Frame: at end of study ]
  • assess the safety & tolerability of BEZ235 SDS as single agent and in combination with trastuzumab administered to patients at the MTD level (Safety expansion part) [ Time Frame: at end of study ]


Original Primary Outcome: Maximum Tolerated Dose (MTD) of BEZ235 (Phase I dose escalation)

Current Secondary Outcome:

  • assess the safety and tolerability of the various formulations of BEZ235 [ Time Frame: at end of study ]
  • Asses the Pharmacokinetics of BEZ235 which includes AUC, Cmax, Tmax, t1/2 as endpoints [ Time Frame: at end of study ]
  • Preliminary anti-tumor activity (tumor response) of BEZ235 SDS as single agent and in combination with trastuzumab [ Time Frame: end of study ]


Original Secondary Outcome: Pharmacokinetics

Information By: Novartis

Dates:
Date Received: February 8, 2008
Date Started: December 21, 2006
Date Completion:
Last Updated: February 13, 2017
Last Verified: February 2017