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Phase II Study of Gleevec/Imatinib Mesylate (STI-571, NCS 716051) in Neurofibromatosis (NF1) Patients With Plexiform Neurofibromas

NCT01673009 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2016-04-06

Study results available
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Summary

THe primary objective is to estimate the response rate at 6 months to Gleevec® in patients with plexiform neurofibromas

Conditions

  • Neurofibromatosis

Interventions

DRUG

Gleevec

Gleevec® will be dosed orally 440 mg/m\^2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2011-12-31
Completion
2012-08-31

Countries

  • United States

Study Locations

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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 NCT01673009 on ClinicalTrials.gov