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

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

Gastrointestinal Stromal Tumor

Completed

2

Start Date 10/15/2007

Age of Trial (yrs) 16.5

Gleevec-resistant

KIT/PDGFRA inhibitor mTOR inhibitor

Block KIT Block KIT Signal Path

Specifically GIST and only GIST

CRAD001C2454

Novartis

Novartis Basel

41 61 324 1111

Oral

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