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NCT00979017 · ClinicalTrials.gov registry record · Phase 2
Avastin/Temozolomide/Irinotecan for Unresectable/Multifocal Glioblastoma Multiforme
A Phase 2 study of Glioblastoma Multiforme and Gliosarcoma, sponsored by Katy Peters.
- Completed
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
- 1
- Study location
NCT00979017: Completed Phase 2 study of Glioblastoma Multiforme and Gliosarcoma, sponsored by Katy Peters.
NCT00979017 is a Phase 2 study of Glioblastoma Multiforme and Gliosarcoma that has completed, run by Katy Peters. The registered enrollment target is 41 participants, below the 96-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (57% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00979017, a Phase 2 study of Glioblastoma Multiforme and Gliosarcoma, has completed, sponsored by Katy Peters.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of the study is to determine the efficacy of Avastin in combination with temozolomide and irinotecan in terms of response rate. The secondary objectives are to describe the overall and progression-free survivals of unresectable patients treated with upfront Avastin, temozolomide and irinotecan and to assess the safety of Avastin, temozolomide and irinotecan in unresectable glioblastoma patients. This is a phase II study with the combination of Avastin, temozolomide and irinotecan for unresectable or multifocal World Health Organization (WHO) grade IV malignant glioma patients. Patients will receive up to four cycles of Avastin, temozolomide and irinotecan. Approximately 41 subjects will take part in this study at Duke.
Primary Outcome
The percentage of participants with a complete or partial response as determined by a modification of the Response Assessment in Neuro-Oncology (RANO) criteria. Complete Response (CR) was defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses) and accompanied by a stable or improving neurologic examination. Partial Response (PR) was defined as greater than or equal to 50% reduction in tumor size on M
Conditions Studied
Interventions
- DRUG Temozolomide
- DRUG Irinotecan
- DRUG Avastin
Study Locations (1)
North Carolina
- The Preston Robert Tisch Brain Tumor Center at Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2009-11 |
| Est. Completion | 2013-01 |
| Phase | Phase 2 |
What the finished NCT00979017 record still lists
NCT00979017 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 96-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (57% lower).
The record links to 2 conditions, with Glioblastoma Multiforme appearing as the primary indexed condition, and to 3 interventions - of which Temozolomide is the first listed.
NCT00979017 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT00979017 about?
NCT00979017 is a clinical study titled "Avastin/Temozolomide/Irinotecan for Unresectable/Multifocal Glioblastoma Multiforme". The primary objective of the study is to determine the efficacy of Avastin in combination with temozolomide and irinotecan in terms of response rate. The secondary objectives are to describe the overall and progression-free survivals of unresectable patients treated with upfront Avastin, temozolomid...
What is the current status of trial NCT00979017?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2009-11. Estimated completion is 2013-01.
What conditions does trial NCT00979017 study?
This clinical trial studies the following conditions: Glioblastoma Multiforme, Gliosarcoma.
What interventions are being tested in trial NCT00979017?
The interventions under investigation include: Temozolomide (DRUG), Irinotecan (DRUG), Avastin (DRUG).
Who is sponsoring clinical trial NCT00979017?
This trial is sponsored by Katy Peters, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00979017 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT00979017's enrollment target sits among peer trials
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