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

Gastrointestinal Stromal Tumors Clinical Trial

Official title: A Phase I-II, Open-label Study of RAD001 in Combination With Glivec®/Gleevec™ (Imatinib) in Patients With Glivec/Gleevec-refractory/Resistant Gastrointestinal Stromal Tumors.

Status Completed

Clinical Trial Summary

This trial was a Phase I/II, non-randomized, open label, multi-center study, following a sequential 2-part design.

Clinical Trial Description

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).

It was decided to discontinue the study and close to further enrollment based on alternative treatment options that became available. Phase 1 and Phase 2 Stratum 1 were ended early on 02-Nov-2006. Investigators were allowed to complete the enrollment in the Phase 2 Stratum 2. ;

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors

• NCT number: NCT01275222
• Study type: Interventional
• Source: Novartis
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 13, 2002
• Completion date: September 3, 2008