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NCT01113398 · ClinicalTrials.gov registry record · Phase 2
AMG 102 and Avastin for Recurrent Malignant Glioma
A Phase 2 study of Glioblastoma Multiforme and Gliosarcoma, sponsored by Katy Peters.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT01113398 is a Phase 2 study of Glioblastoma Multiforme and Gliosarcoma that has completed, run by Katy Peters. The registered enrollment target is 36 participants, below the 96-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01113398, a Phase 2 study of Glioblastoma Multiforme and Gliosarcoma, has completed, sponsored by Katy Peters.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary purpose of the study is to assess the response rate of AMG 102 and Avastin treatment in subjects with advanced malignant glioma. Secondary objectives are to estimate overall survival and 6-month progression-free survival rates in this population and to assess the safety of this combination in this population. Patients must have recurrent histologically confirmed diagnosis of World Health Organization (WHO) grade IV malignant glioma (glioblastoma multiforme or gliosarcoma) with no more than 3 prior progressions. Subjects will receive Avastin and AMG 102 every two weeks. Avastin will be administered prior to AMG 102. Up to 36 adult subjects will take part in this study at Duke. In initial Phase I and II clinical trials, four potential Avastin-associated safety issues were identified: hypertension, proteinuria, thromboembolic events, and hemorrhage. The most common side effect for AMG 102 have been nausea and fatigue.
Conditions Studied
Interventions
- DRUG Avastin
- DRUG AMG 102
Study Locations (1)
North Carolina
- The Preston Robert Tisch Brain Tumor Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2010-08 |
| Est. Completion | 2015-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01113398
The ClinicalTrials.gov registry entry for NCT01113398 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 96-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (62% lower). The listed sponsor is Katy Peters, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Glioblastoma Multiforme appearing as the primary indexed condition, and to 2 interventions - of which Avastin is the first listed.
NCT01113398 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT01113398 about?
NCT01113398 is a clinical study titled "AMG 102 and Avastin for Recurrent Malignant Glioma". The primary purpose of the study is to assess the response rate of AMG 102 and Avastin treatment in subjects with advanced malignant glioma. Secondary objectives are to estimate overall survival and 6-month progression-free survival rates in this population and to assess the safety of this combinati...
What is the current status of trial NCT01113398?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2010-08. Estimated completion is 2015-09.
What conditions does trial NCT01113398 study?
This clinical trial studies the following conditions: Glioblastoma Multiforme, Gliosarcoma.
What interventions are being tested in trial NCT01113398?
The interventions under investigation include: Avastin (DRUG), AMG 102 (DRUG).
Who is sponsoring clinical trial NCT01113398?
This trial is sponsored by Katy Peters, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01113398 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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