TRIAL DETAIL

A Dose-finding Study of a Combination of Imatinib and BKM120 in the Treatment of 3rd Line GIST Patients

Drug:
Trial Name:
A Dose-finding Study of a Combination of Imatinib and BKM120 in the Treatment of 3rd Line GIST Patients
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Completed
Phase:
1
Start Date 04/01/2012
Age of Trial (yrs) 9.7
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT/PDGFRA + PI3K Inhibitor
Strategy:
Block KIT + Block related tumor signal paths
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
CSTI571X2101
Sponsor:
Novartis Pharmaceuticals
Patient Contact:
Contact: Novartis Pharmaceutical 1-888-669-6682
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
PI3K has been shown to be an important signaling protein that is downstream from KIT. Lab experiments suggest that inhibiting KIT and PI3K at the same time may be effective and that the effect may even persist for some time after stopping the combination.
This is a phase 1 trial designed to look at dose and safety. A secondary endpoint will be to examine preliminary efficacy measured as benefit lasting at least 16 weeks.
Experimental: STI571 (imatinib mesylate) and BKM120
The study will comprise of 2 parts. A dose escalation and a dose expansion part. Patients will receive increasing doses of BKM120 (40, 60, 80, 100 mg) in combination with 400mg imatinib daily until maximum tolerated dose (MTD) and rapid phase 2 dose (RP2D) is determined. 35 patients will enter the expansion phase with 18 patients having a pharmacokintic (PK) run-in period of 8 days receiving imatinib monotherapy or BKM120 monotherapy.
Patients may receive either imatinib or BKM120 first for 8 days followed by adding the other drug.

Trial Links

Trial Results

 

Drug Information

ASCO -2012 - Efficacy of a phosphoinositol 3 kinase (PI3K) inhibitor in gastrointestinal stromal tumor (GIST) models (used a different PI3K inhibitor + imatinib)
 
ASCO 2010 - Activity of GDC-0941, an inhibitor of phosphoinositol 3 kinase (PI3K), in gastrointestinal stromal tumor (GIST) xenograft and duration of response after discontinuation of treatment in combination with imatinib.
 

Trial Sites

Name
Address
City
State
Zip
Country
Leiden
2300 RC
Netherlands
450 Brookline Ave
Boston
MA
02215-5450
USA
1275 York Ave
New York
NY
10065
USA
Seattle
WA
98104
USA
Herestraat 49
Leuven
Belgium
600 West 10th Avenue
Vancouver
BC
V5Z 4E6
Canada
28 rue Laennec
Lyon
Rhone
69373
France
Villejuif
Val de Narne
94805
France
Munich
D-81377
Germany
Lindenberger Weg 80
Berlin
D-13125
Germany
119-129
Barcelona
08035
Spain
197 Fulham Rd.
London
SW3 6JJ
UK
550 Wilmslow Rd
Manchester
Lancashire
M20 4BX
UK
via Giacomo
Milan
20133
Italy
Chiba
277-8577
Japan