A Study of the Efficacy and Safety of Imatinib Mesylate in Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors Expressing C-kit Gene

PHASE2CompletedINTERVENTIONAL
Enrollment

148

Participants

Timeline

Start Date

June 30, 2000

Primary Completion Date

June 30, 2013

Study Completion Date

June 30, 2013

Conditions
Unresectable or Metastatic Malignant Gastrointestinal Stromal Tumor (GIST)
Interventions
DRUG

Imatinib mesylate

Participants were randomized 1:1 to receive imatinib mesylate 400 mg/day or 600 mg/day. Upon unsatisfactory treatment effect on the starting dose of 400 mg/day or 600 mg/day imatinib mesylate, in the opinion of the treating physician, a dose increase up to 600 mg/day or 800 mg/day, was allowed provided that the participant continued to benefit from the treatment and in the absence of safety concerns.

Trial Locations (5)

3220

Novartis Investigative Site, Geelong

19111

Fox Chase Cancer Center, Philadelphia

97201

Oregon Health Sciences University Dept. of Oregon Health Sci., Portland

02115

Dana Farber Cancer Institute Dept of Sarcoma Oncology, Boston

FIN-00029

Novartis Investigative Site, Helsinki

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY