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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 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.

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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.

Interventions

  • DRUG Erlotinib

Study Locations (1)

New York

  • Lenox Hill Brain Tumor Center - New York

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2006-03
Est. Completion 2014-05
Phase Phase 1

Sponsor

Northwell Health

370 total trials

What the Registry Record Tells You About NCT00301418

The ClinicalTrials.gov registry entry for NCT00301418 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 97-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (89% lower). The listed sponsor is Northwell Health, which has 370 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.