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

NCT01031628 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2013-09-09

Study results available
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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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Suzanne George, MD · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01031628 on ClinicalTrials.gov