TRIAL DETAIL

Everolimus in Combination With Imatinib in Patients With Glivec Refractory/Resistant Gastrointestinal Stromal Tumors

Drug:
Trial Name:
Everolimus in Combination With Imatinib in Patients With Glivec Refractory/Resistant Gastrointestinal Stromal Tumors
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Completed
Phase:
2
Start Date 11/01/2002
Age of Trial (yrs) 19.7
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT/PDGFRA inhibitor mTOR inhibitor
Strategy:
Block KIT Block KIT Signal Path
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
CRAD001C2206
Sponsor:
Novartis Pharmaceuticals
Patient Contact:
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
This trial was a Phase I/II, non-randomized, open label, multi-center study, following a sequential 2- part design. The first part, Phase I, was designed to assess whether there is a pharmacokinetic interaction between Glivec/Gleevec (imatinib) and RAD001(everolimus) as well as to collect safety data when these two drugs are co-administered. The second part, (Phase II), was designed to assess the potential efficacy of the combination in imatinib-resistant GIST patients in two strata of patients:

* Patients resistant to imatinib as first-line drug therapy and in whom the maximum tolerated dose was at least 600 mg/d (Stratum 1, first-line resistant/refractory)
* Patients resistant to imatinib as well as to post-imatinib drug therapy (Stratum 2, post second-line therapy)

Trial Links

Trial Results

 
 

Drug Information

Oncogenic Kit signaling and therapeutic intervention in a mouse model of gastrointestinal stromal tumor (Full text article)
 
Everolimus alters imatinib blood partition in favour of the erythrocyte.
 
Gleevec Blood levels (LRG article)
 

Trial Sites

Name
Address
City
State
Zip
Country
450 Brookline Ave
Boston
MA
02215-5450
USA
333 Cottman Ave
Philadelphia
PA
19111
USA
10945 Le Conte Ave.
Los Angeles
CA
90095
USA
3181 S.W. Sam Jackson Park Rd.
Portland
OR
97239
USA
28 rue Laennec
Lyon
Rhone
69373
France
Schwanebecker Chaussee
Berlin
Germany