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Safety And Effectiveness Of Daily Dosing With Sunitinib Or Imatinib In Patients With Gastrointestinal Stromal Tumors

NCT00372567 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2011-03-17

Study results available
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Summary

A phase IIIb study of patients with gastrointestinal stromal tumors who have had progressive disease while on 400 mg imatinib. Patients will be randomly assigned to either sunitinib 37.5 mg daily or imatinib 800 mg daily. This study will find out the benefits and potential side effects of taking sunitinib or imatinib for approximately one year.

Conditions

  • Gastrointestinal Stromal Tumor

Interventions

DRUG

sunitinib malate

37.5 mg daily

DRUG

imatinib mesylate

800mg daily

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • United States
  • Germany
  • Hong Kong
  • Italy
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT00372567 on ClinicalTrials.gov