A Study of the Efficacy and Safety of Imatinib Mesylate in Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors Expressing c-Kit Gene (Extension of US Phase II study, B2222)

A Study of the Efficacy and Safety of Imatinib Mesylate in Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors Expressing c-Kit Gene (Extension of US Phase II study, B2222)

Gastrointestinal Stromal Tumor

Completed

2

Start Date 10/01/2003

Age of Trial (yrs) 21.2

First-line

KIT/PDGFRA inhibitor

Block KIT

Specifically GIST and only GIST

CSTI571B2222E1 B2222

Novartis

Oral

Extension of the B2222 study.

In the core study, patients with unresectable or metastatic gastrointerstinal stromal tumors expressing c-kit were treated with either 400 mg or 600 mg imatinib mesylate for 3 years. This 4-year extension study allows patients who successfully completed the core study to continue study treatment with imatinib mesylate.