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NCT01475006 · ClinicalTrials.gov registry record · Phase 1
AMG 595 First-in-Human in Recurrent Gliomas
A Phase 1 study of Glioblastoma Multiforme and Advanced Malignant Glioma, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 4
- Study locations
NCT01475006: Completed Phase 1 study of Glioblastoma Multiforme and Advanced Malignant Glioma, sponsored by Amgen.
NCT01475006 is a Phase 1 study of Glioblastoma Multiforme and Advanced Malignant Glioma that has completed, run by Amgen. The registered enrollment target is 32 participants, below the 97-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (67% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01475006, a Phase 1 study of Glioblastoma Multiforme and Advanced Malignant Glioma, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is an open-label, sequential dose exploration study of single agent AMG 595 administered in subjects with recurrent glioblastoma multiforme (GBM) and/or anaplastic astrocytomas (AA). The purpose of the study is to evaluate safety, tolerability, and pharmacokinetics (PK) of AMG 595, and also to evaluate the objective response rate in subjects receiving AMG 595. This study will be conducted in two parts. Part 1 will explore doses of AMG 595 in subjects with recurrent GBM and/or AA. Part 2 (dose expansion) will examine the MTD established in Part 1 in subjects with recurrent GBM.
Conditions Studied
Interventions
- DRUG AMG 595
Study Locations (4)
California
- Research Site - Los Angeles
Massachusetts
- Research Site - Boston
Ohio
- Research Site - Cincinnati
Victoria
- Research Site - Parkville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2012-02 |
| Est. Completion | 2016-04 |
| Phase | Phase 1 |
What the finished NCT01475006 record still lists
NCT01475006 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 97-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (67% lower).
The record links to 3 conditions, with Glioblastoma Multiforme appearing as the primary indexed condition, and to 1 intervention - of which AMG 595 is the first listed.
NCT01475006 reports a single indexed study location in California, Massachusetts, Ohio.
Frequently Asked Questions
What is clinical trial NCT01475006 about?
NCT01475006 is a clinical study titled "AMG 595 First-in-Human in Recurrent Gliomas". This is an open-label, sequential dose exploration study of single agent AMG 595 administered in subjects with recurrent glioblastoma multiforme (GBM) and/or anaplastic astrocytomas (AA). The purpose of the study is to evaluate safety, tolerability, and pharmacokinetics (PK) of AMG 595, and also to ...
What is the current status of trial NCT01475006?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2012-02. Estimated completion is 2016-04.
What conditions does trial NCT01475006 study?
This clinical trial studies the following conditions: Glioblastoma Multiforme, Advanced Malignant Glioma, Anaplastic Astrocytomas.
What interventions are being tested in trial NCT01475006?
The interventions under investigation include: AMG 595 (DRUG).
Who is sponsoring clinical trial NCT01475006?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01475006 being conducted?
This trial has 4 study locations across California, Massachusetts, Ohio, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01475006's enrollment target sits among peer trials
32 58th of 88 higher than 29 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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