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SUTENT (SUNITINIB, SU11248)in Patients With Recurrent or Progressive Glioblastoma Multiforme

NCT00535379 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2010-08-30

No results posted yet for this study

Summary

Clinical Part:

The objective of this study is to determine the efficacy and safety of SUTENT in patients with recurrent or progressive glioblastoma multiforme.Patients with tissue based diagnosis of intracranial glioblastoma multiforme, above 18 years of age and of both genders, who have a first tumor recurrence or progress after surgery, radiation- and chemotherapy will be included. The hypothesis is that SUTENT will significantly increase the progression free survival rate at 6 months in the study population.

Conditions

Interventions

DRUG

Sunitinib

Patients will receive SUTENT 37.5mg (3 x 12.5mg capsules) PO daily in the morning after breakfast. After 2 weeks without treatment-related adverse events grade ≥ 2 (ECOG common toxicity criteria: refer to Protocol Attachment A.4) a SUTENT dose escalation to 50mg (4 x 12.5mg capsules) PO daily has to be performed. Treatment will continue until patients develop progression of disease or until unacceptable adverse events occur.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Medical University Innsbruck

    lead OTHER

Principal Investigators

  • Guenther Stockhammer, MD, Prof. · Medical University Innsbruck

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2010-12-31
Completion
2011-01-31

Countries

  • Austria
  • Germany

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 NCT00535379 on ClinicalTrials.gov