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NCT01257594 · ClinicalTrials.gov registry record · Phase 1

EGFR Inhibition Using Weekly Erlotinib for Recurrent Malignant Gliomas

A Phase 1 study of Brain Cancer, sponsored by Andrew B Lassman, MD.

Completed
Registry status
Phase 1
Development phase
22
Enrollment target
4
Study locations

NCT01257594: Completed Phase 1 study of Brain Cancer, sponsored by Andrew B Lassman, MD.

NCT01257594 is a Phase 1 study of Brain Cancer that has completed, run by Andrew B Lassman, MD. The registered enrollment target is 22 participants, below the 507-participant average among 47 other Brain Cancer trials with a reported enrollment target (96% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01257594, a Phase 1 study of Brain Cancer, has completed, sponsored by Andrew B Lassman, MD.

COMPLETED
Registry status
Phase 1
Development phase
22 participants
Enrollment target
4
Study locations

Study Summary

The purpose of this study is to test the effectiveness of a drug called erlotinib in treating the tumor. This is a multi-center pilot study that explores efficacy and molecular effects of high dose weekly erlotinib for recurrent EGFR vIII mutant malignant gliomas, and correlate molecular profile of pre-treatment tissue with outcome.

Primary Outcome

All patients will have their tumor measurements recorded at baseline and at the time of each MRI/CT scan. Clinical efficacy of pulsatile dosing with the EGFR Tyrosine Kinase Inhibitor erlotinib in patient with EGFR vIII mutant, recurrent malignant gliomas will be explored by determination of radiographic response and 6 month progression-free survival (6mPFS rate).

Conditions Studied

Interventions

  • PROCEDURE Cytoreductive Surgery
  • DRUG erlotinib

Study Locations (4)

New York

  • Memorial Sloan-Kettering Cancer Center at Commack - Commack
  • Columbia University Irving Medical Center - New York
  • Memorial Sloan Kettering Cancer Center - New York

New Jersey

  • Memorial Sloan-Kettering at Basking Ridge - Basking Ridge

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2011-01-07
Est. Completion 2018-12-31
Phase Phase 1
Andrew B Lassman, MD

2 total trials

What the finished NCT01257594 record still lists

NCT01257594 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 507-participant average among 47 other Brain Cancer trials with a reported enrollment target (96% lower).

The record links to 1 condition, with Brain Cancer appearing as the primary indexed condition, and to 2 interventions - of which Cytoreductive Surgery is the first listed.

NCT01257594 reports a single indexed study location in New York, New Jersey.

Frequently Asked Questions

What is clinical trial NCT01257594 about?

NCT01257594 is a clinical study titled "EGFR Inhibition Using Weekly Erlotinib for Recurrent Malignant Gliomas". The purpose of this study is to test the effectiveness of a drug called erlotinib in treating the tumor. This is a multi-center pilot study that explores efficacy and molecular effects of high dose weekly erlotinib for recurrent EGFR vIII mutant malignant gliomas, and correlate molecular profile of ...

What is the current status of trial NCT01257594?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2011-01-07. Estimated completion is 2018-12-31.

What conditions does trial NCT01257594 study?

This clinical trial studies the following conditions: Brain Cancer.

What interventions are being tested in trial NCT01257594?

The interventions under investigation include: Cytoreductive Surgery (PROCEDURE), erlotinib (DRUG).

Who is sponsoring clinical trial NCT01257594?

This trial is sponsored by Andrew B Lassman, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01257594 being conducted?

This trial has 4 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Brain Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01257594's enrollment target sits among peer trials

22 36th of 47 higher than 12 of 47 other Brain Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Brain Cancer 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01257594, the US trial registry maintained by the National Library of Medicine. NCT01257594 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.