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

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

Gastrointestinal Stromal Tumor

Completed

2

Start Date 11/01/2002

Age of Trial (yrs) 21.5

Gleevec-resistant

KIT/PDGFRA inhibitor mTOR inhibitor

Block KIT Block KIT Signal Path

Specifically GIST and only GIST

CRAD001C2206

Novartis Pharmaceuticals

Oral

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)