CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Sunitinib Malatedrug
Likely dose
Sunitinib Malate 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00606008
NCT00606008Phase 2Completed

A Phase II Trial of Sutent (Sunitinib; SU011248) for Recurrent Anaplastic Astrocytoma and Glioblastoma Multiforme

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Feb 1, 2008·Updated Nov 19, 2012

In Brief

A Phase 2 clinical trial evaluating Sunitinib Malate for Anaplastic Astrocytoma and Glioblastoma. Completed, enrolled 30 participants across 1 site.

Detailed Summary

We are asked patients to take part in this study because they had recurrent (returned) (1st or 2nd) anaplastic astrocytoma (AA) or glioblastoma multiforme (GBM). The purposes of this study are: * To see if Sutent has any change on the patient and their cancer. * To see if Sutent will slow or stop the growth of their tumor. * To measure the safety of Sutent. Sutent is Food and Drug Administration (FDA) approved to treat patients with a gastrointestinal stromal tumor after the disease worsened while taking another medicine called imatinib mesylate or when imatinib mesylate cannot be taken. Sutent is also FDA approved to treat patients with advanced renal cell carcinoma. At this time, it is not known whether Sutent will improve symptoms, or help patients with this disease live longer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsPfizer

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 1, 2008
Enrollment StartMar 1, 2007
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 18.4 years ago

Interventions

Sunitinib Malatedrug

Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study.