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NCT00301418 · ClinicalTrials.gov registry record · Phase 1
Oral Tarceva Study for Recurrent/Residual Glioblastoma Multiforme and Anaplastic Astrocytoma
A Phase 1 study of Glioblastoma Multiforme and Anaplastic Astrocytoma, sponsored by Northwell Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT00301418: Completed Phase 1 study of Glioblastoma Multiforme and Anaplastic Astrocytoma, sponsored by Northwell Health.
NCT00301418 is a Phase 1 study of Glioblastoma Multiforme and Anaplastic Astrocytoma that has completed, run by Northwell Health. The registered enrollment target is 11 participants, below the 97-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00301418, a Phase 1 study of Glioblastoma Multiforme and Anaplastic Astrocytoma, has completed, sponsored by Northwell Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will offer a safe treatment for patients with relapsing recurring glioblastoma (GBM) or anaplastic astrocytoma (AA). The trial will test the hypothesis that Erlotinib (Tarceva, OSI-774) can be safely used up to a dose of 150 mg two times a day for 12 months to ultimately enhance survival of patients with relapsed/refractory GBM/AA. Correlation of response to Tarceva with particular genetic alterations including epidermal growth factor receptor variant type III (EGFRvIII) amplification and phosphatase and tensin homolog (mutated in multiple advanced cancers 1) (PTEN) loss will be studied.
Primary Outcome
Greater than or equal to Grade 2 Adverse Event
Conditions Studied
Interventions
- DRUG Erlotinib
Study Locations (1)
New York
- Lenox Hill Brain Tumor Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2006-03 |
| Est. Completion | 2014-05 |
| Phase | Phase 1 |
What the finished NCT00301418 record still lists
NCT00301418 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 97-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Glioblastoma Multiforme appearing as the primary indexed condition, and to 1 intervention - of which Erlotinib is the first listed.
NCT00301418 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT00301418 about?
NCT00301418 is a clinical study titled "Oral Tarceva Study for Recurrent/Residual Glioblastoma Multiforme and Anaplastic Astrocytoma". This study will offer a safe treatment for patients with relapsing recurring glioblastoma (GBM) or anaplastic astrocytoma (AA). The trial will test the hypothesis that Erlotinib (Tarceva, OSI-774) can be safely used up to a dose of 150 mg two times a day for 12 months to ultimately enhance survival ...
What is the current status of trial NCT00301418?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2006-03. Estimated completion is 2014-05.
What conditions does trial NCT00301418 study?
This clinical trial studies the following conditions: Glioblastoma Multiforme, Anaplastic Astrocytoma.
What interventions are being tested in trial NCT00301418?
The interventions under investigation include: Erlotinib (DRUG).
Who is sponsoring clinical trial NCT00301418?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00301418 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00301418's enrollment target sits among peer trials
11 80th of 88 higher than 8 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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