TRIAL DETAIL

Treatment of Patients With Everolimus and Imatinib Mesylate Who Have Progressive Gastro Intestinal Stromal Tumors (GIST) and Are Resistant to Imatinib Mesylate

Drug:
Trial Name:
Treatment of Patients With Everolimus and Imatinib Mesylate Who Have Progressive Gastro Intestinal Stromal Tumors (GIST) and Are Resistant to Imatinib Mesylate
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Completed
Phase:
2
Start Date 10/15/2007
Age of Trial (yrs) 13.7
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:
CRAD001C2454
Sponsor:
Novartis
Patient Contact:
Novartis Basel
Contact email:
Contact Phone:
41 61 324 1111
Randomized:
IV or Oral:
Oral
Trial Notes:
The purpose of this multicenter, single-arm, Simon two-stage, phase II trial is to determine the efficacy and safety of everolimus in combination with Imatinib mesylate in patients with previously treated, histologically proven GIST whose disease has recurred or progressed while receiving 400 mg/day of Imatinib mesylate at any time during at least a 2 months' treatment period.
Further study details as provided by Novartis:
Primary Outcome Measures:

* Tumor assessments should be performed by a CT or MRI scan after 4 months. Response to treatment with RAD001 plus Imatinib mesylate at 4 months (defined as progression-free survival (PFS) at 4 months).


Secondary Outcome Measures:

* Tolerability and safety assessed by AEs and SAEs. Objective tumor response rate (complete response [CR] and partial response [PR]) assessed by CT or MRI PFS at month 12 for patients with data available from follow up observation (optional)


Total Enrollment: 53

Study start: October 2006

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
Bad Saarow
Germany
Koln
Germany
Dusseldorf
Germany
Frankfurt
Germany
Mannheim
68135
Germany
Munchen
Germany
Tubingen
Germany
Essen
Germany
Hannover
Germany