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NCT00606008 · ClinicalTrials.gov registry record · Phase 2
A Phase II Trial of Sutent (Sunitinib; SU011248) for Recurrent Anaplastic Astrocytoma and Glioblastoma
A Phase 2 study of Glioblastoma and Anaplastic Astrocytoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT00606008: Completed Phase 2 study of Glioblastoma and Anaplastic Astrocytoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT00606008 is a Phase 2 study of Glioblastoma and Anaplastic Astrocytoma that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 30 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00606008, a Phase 2 study of Glioblastoma and Anaplastic Astrocytoma, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Complete Response: Disappearance of all lesions, disease signs and symptoms related to the tumor. Partial Response (PR): When compared with pretreatment measurements, a reduction of 50% decrease in the sum of the longest diameters of all target enhancing lesions, taking as reference the baseline sum of the longest diameter. Stable Disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum
Conditions Studied
Interventions
- DRUG Sunitinib Malate
Study Locations (1)
Florida
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2007-03 |
| Est. Completion | 2012-08 |
| Phase | Phase 2 |
What the finished NCT00606008 record still lists
NCT00606008 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (72% lower).
The record links to 2 conditions, with Glioblastoma appearing as the primary indexed condition, and to 1 intervention - of which Sunitinib Malate is the first listed.
NCT00606008 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT00606008 about?
NCT00606008 is a clinical study titled "A Phase II Trial of Sutent (Sunitinib; SU011248) for Recurrent Anaplastic Astrocytoma and Glioblastoma". 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 ...
What is the current status of trial NCT00606008?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2007-03. Estimated completion is 2012-08.
What conditions does trial NCT00606008 study?
This clinical trial studies the following conditions: Glioblastoma, Anaplastic Astrocytoma.
What interventions are being tested in trial NCT00606008?
The interventions under investigation include: Sunitinib Malate (DRUG).
Who is sponsoring clinical trial NCT00606008?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00606008 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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30 124th of 199 higher than 69 of 199 other Glioblastoma trials
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