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Efficacy of 400 Mg Versus 800 Mg Imatinib in Chronic Myeloid Leukemia in Chronic Phase Patients - TOPS (Tyrosine Kinase Inhibitor Optimization and Selectivity)

NCT00124748 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 476

Last updated 2012-02-03

Study results available
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Summary

This study investigated the safety and efficacy of 400mg Versus 800mg imatinib in patients with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase (CML-CP) using molecular endpoints.

Conditions

  • Leukemia, Myeloid, Chronic Phase

Interventions

DRUG

Imatinib mesylate

Imatinib is packaged in bottles as 100mg and 400mg tablets

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Canada
  • Italy

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 NCT00124748 on ClinicalTrials.gov