TRIAL DETAIL

A Phase I/II Study of BGT226 in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast Cancer

Drug:
Trial Name:
A Phase I/II Study of BGT226 in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast Cancer
NCT#:
Conditions:
Solid Tumors
Status:
Completed
Phase:
1
Start Date 12/15/2007
Age of Trial (yrs) 14.8
Treatment Phase:
Gleevec-resistant
Drug Category:
mTOR inhibitor PI3K inhibitor
Strategy:
Block KIT Signal Path
Trial Type:
GIST not specified. GIST patients known to be enrolled.
Other Protocol IDs:
CBGT226A2101
Sponsor:
Novartis
Patient Contact:
Novartis
Contact email:
Contact Phone:
800 340-6843
Randomized:
IV or Oral:
Oral
Trial Notes:
This is a phase I/II clinical research study with BGT226, 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.

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 will enroll advanced solid tumors. Phase II expansion part will enroll advanced breast cancer. An effort will be made to enrich the trial population with Cowden Syndrome patients with advanced solid malignancies.

Trial Links

Trial Results

 

Drug Information

Trial Sites

Name
Address
City
State
Zip
Country
10441 W Twain Ave
Las Vegas
NV
89135
USA
450 Brookline Ave
Boston
MA
02215-5450
USA
55 Fruit Street
Boston
MA
02114
USA
7979 Wurzbach Rd.
San Antonio
TX
78229
USA
119-129
Barcelona
08035
Spain
610 University Ave
Toronto
ON
M5G 2M9
Canada