NCT01031628

Study of Dose Escalation Versus no Dose Escalation of Imatinib in Metastatic Gastrointestinal Stromal Tumors (GIST) Patients

A Randomized, Phase 3 Study of Dose Escalation Versus No Dose Escalation of Imatinib In Metastatic GIST Patients With Imatinib Trough Levels Less Than 1100 Nanograms/mL

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Sarcoma Alliance for Research through Collaboration · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if escalating the dose of imatinib to keep the drug blood level at ≥ 1100 ng/ml leads to better outcomes for patients.

Conditions

• Gastrointestinal Stromal Tumors

Interventions

Type	Name	Description
DRUG	Imatinib mesylate	400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
DRUG	Imatinib mesylate	600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
DRUG	Imatinib mesylate	400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2009-12-14
• Last updated: 2013-09-09
• Results posted: 2013-08-16

Locations

13 sites across 1 country: United States