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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: Completed Phase 2 study of Glioblastoma Multiforme and Gliosarcoma, sponsored by Katy Peters.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The percentage of participants with a complete or partial response as determined by modified Response Assessment in Neuro-Oncology (RANO) criteria will be determined. Complete Response (CR) is 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) is defined as greater than or equal to 50% reduction in tumor size
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 |
What the finished NCT01113398 record still lists
NCT01113398 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 96-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (62% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT01113398's enrollment target sits among peer trials
36 52nd of 88 higher than 34 of 88 other Glioblastoma Multiforme trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma Multiforme trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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