TRIAL DETAIL

Treatment of Patients With RAD001 Who Have Progressive Sarcoma

Drug:
Trial Name:
Treatment of Patients With RAD001 Who Have Progressive Sarcoma
NCT#:
Conditions:
Sarcoma
Status:
Completed
Phase:
2
Start Date 03/01/2008
Age of Trial (yrs) 14.3
Treatment Phase:
Gleevec-resistant
Drug Category:
mTOR inhibitor
Strategy:
Block KIT Signal Path
Trial Type:
Specifically GIST plus other cancers
Other Protocol IDs:
CRAD001C24114, EUDRACT- Nr. 2007-005294-60
Sponsor:
Novartis
Patient Contact:
Novartis Pharmaceuticals +1 800-340-6843
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral Intravenous
Trial Notes:
The purpose of this multicenter, two-arm (sic), exact binomial single-stage, phase II trial is to determine the preliminary efficacy and safety of RAD001 in patients with histological evidence of progressive or metastatic bone or soft tissue sarcoma.

In a separate arm, RAD001 will be tested in GIST patients that have failed or are intolerant to imatinib or sunitinib.

RAD001 is an inhibitor of mTOR, an important target that is downstream of many receptor tyrosine kinases including KIT.

Trial Links

 

Trial Results

 

Drug Information

RAD001 shows promise in renal cell cancer patients
 
Afinitor.com
 
FDA press release about Afinitor approval for Kidney Cancer.
 
USA prescribing information (PDF)
 
Everolimus alters imatinib blood partition in favour of the erythrocyte.
 

Trial Sites

Name
Address
City
State
Zip
Country
Berlin
Germany
Munchen
Germany
Dusseldorf
Germany
Mannheim
68135
Germany
Milan
20132
Italy
Essen
Germany