TRIAL DETAIL

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

Drug:
Trial Name:
A Phase I/II Study of BEZ235 in Patients With Advanced Solid Malignancies Enriched by Patients With Advanced Breast Cancer
NCT#:
Conditions:
Solid Tumors
Status:
Ongoing, but not recruiting
Phase:
1
Start Date 12/15/2006
Age of Trial (yrs) 15.5
Treatment Phase:
Gleevec-resistant
Drug Category:
mTOR inhibitor PI3K inhibitor
Strategy:
Block KIT Signal Path
Trial Type:
GIST not specified. GIST patient enrollment unknown.
Other Protocol IDs:
CBEZ235A2101
Sponsor:
Novartis
Patient Contact:
Novartis
Contact email:
Contact Phone:
862-778-8300
Randomized:
IV or Oral:
Oral
Trial Notes:
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.

Trial Links

 
 
 

Trial Results

 

Drug Information

Identification and characterization of NVP-BEZ235, a new orally available dual phosphatidylinositol 3-kinase/mammalian target of rapamycin inhibitor with potent in vivo antitumor activity
 
Novartis Pipeline BEZ235
 
ASCO - 2010 Activity of dual PI3K/mTOR inhibitor, NVP-BEZ235, and mTOR inhibitor, RAD001 (everolimus), in endometrial cancer cell lines.
 

Trial Sites

Name
Address
City
State
Zip
Country
10441 W Twain Ave
Las Vegas
NV
89135
USA
3322 West End Avenue
Nashville
TN
37203
USA
1505 Holcombe Blvd.
Houston
TX
77030
USA
119-129
Barcelona
08035
Spain