MedTrace Logo

Study of Sutent®/Sunitinib (SU11248) in Subjects With NF-1 Plexiform Neurofibromas

NCT01402817 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2018-03-14

Study results available
· View outcomes & findings →

Summary

This is a pilot study to determine if adults and children with neurofibromatosis type 1 who have plexiform tumors given Sutent® respond to this drug therapy.

Conditions

  • Neurofibromatosis
  • NF1
  • Plexiform Neurofibromas

Interventions

DRUG

Sutent®/Sunitinib

Upon enrollment, subjects will receive Sutent® orally. Adults (Age \>18) will receive 25mg. Children will receive 10mg/m2/day. All subjects will take the daily dose for 28 days followed by a 14 day rest period. If subjects tolerate the initial dose, adults will be increased to 37.5mg and children will be increased to 15mg/m2/day. Again, subjects will take that dose for 28 days followed by a rest period of 14 days. Adults who tolerate the increase will go up to the maximum dose of 50mg. The maximum dose for children is 15mg/m2/day.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Pfizer

    collaborator INDUSTRY

  • Indiana University

    lead OTHER

Principal Investigators

  • Chie-Schin Shih, MD · Indiana University

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
2012-03-31
Primary Completion
2015-10-31
Completion
2018-02-14

Countries

  • United States

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 NCT01402817 on ClinicalTrials.gov