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NCT00116376 · ClinicalTrials.gov registry record · Phase 1

Study of AEE788 in Patients With Recurrent/Relapse Glioblastoma Multiforme (GBM)

A Phase 1 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
64
Enrollment target

NCT00116376 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 64 participants.

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The verdict

NCT00116376, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
64 participants
Enrollment target

Study Summary

AEE788 is an orally active, reversible, small-molecule, multi-targeted kinase inhibitor with potent inhibitory activity against the ErbB and VEGF receptor family of tyrosine kinases. It has an IC50 of less than 100 nM against p-EGFR, p-ErbB2, and p-KDR (VEGFR2). This study will assess the safety, pharmacokinetic/pharmacodynamic (PK/PD) profiles and clinical activity of AEE788 in a recurrent GBM population.

Interventions

  • DRUG AEE788

Trial Details

FieldValue
Enrollment Target 64 participants
Start Date 2004-01
Est. Completion 2005-11
Phase Phase 1

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT00116376

The ClinicalTrials.gov registry entry for NCT00116376 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which AEE788 is the first listed.

NCT00116376 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00116376 about?

NCT00116376 is a clinical study titled "Study of AEE788 in Patients With Recurrent/Relapse Glioblastoma Multiforme (GBM)". AEE788 is an orally active, reversible, small-molecule, multi-targeted kinase inhibitor with potent inhibitory activity against the ErbB and VEGF receptor family of tyrosine kinases. It has an IC50 of less than 100 nM against p-EGFR, p-ErbB2, and p-KDR (VEGFR2). This study will assess the safety, ph...

What is the current status of trial NCT00116376?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2004-01. Estimated completion is 2005-11.

What interventions are being tested in trial NCT00116376?

The interventions under investigation include: AEE788 (DRUG).

Who is sponsoring clinical trial NCT00116376?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

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

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.