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NCT01989052 · ClinicalTrials.gov registry record · Phase 1

Ph 1/2 CTO With Lomustine for Bevacizumab-Naive Recurrent Glioma

A Phase 1 study, sponsored by Annick Desjardins.

Terminated
Registry status
Phase 1
Development phase
9
Enrollment target

NCT01989052 is a Phase 1 study that was terminated before completion, run by Annick Desjardins. The registered enrollment target is 9 participants.

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The verdict

NCT01989052, a Phase 1 study, was terminated before completion, sponsored by Annick Desjardins.

TERMINATED
Registry status
Phase 1
Development phase
9 participants
Enrollment target

Study Summary

This is a Phase 1/2 study of the combination of CTO with lomustine in patients with recurrent malignant glioma to be treated at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke. The Primary Objectives are: * Phase 1: To determine the maximum tolerated dose (MTD) of CTO when combined with lomustine among patients with recurrent malignant glioma (World Health Organization (WHO) grade III or IV) who have not been previously treated with bevacizumab. * Phase 2: To assess the efficacy of CTO (either in monotherapy or in combination with lomustine) compared to lomustine alone in patients with recurrent WHO grade IV malignant gliomas that have not been previously treated with bevacizumab based upon 6-month progression free survival (PFS6). Note: This study was terminated early due to funding issues. At the time of termination, the study was still in Phase 1 and no MTD for the combination of CTO and lomustine had been determined for this population. Phase 2 will not proceed.

Interventions

  • DRUG Lomustine
  • DRUG CTO

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2014-05
Est. Completion 2016-02
Phase Phase 1

Sponsor

Annick Desjardins

9 total trials

What the Registry Record Tells You About NCT01989052

The ClinicalTrials.gov registry entry for NCT01989052 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Annick Desjardins, which has 9 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Lomustine is the first listed.

NCT01989052 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01989052 about?

NCT01989052 is a clinical study titled "Ph 1/2 CTO With Lomustine for Bevacizumab-Naive Recurrent Glioma". This is a Phase 1/2 study of the combination of CTO with lomustine in patients with recurrent malignant glioma to be treated at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke. The Primary Objectives are: * Phase 1: To determine the maximum tolerated dose (MTD) of CTO when combined wit...

What is the current status of trial NCT01989052?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2014-05. Estimated completion is 2016-02.

What interventions are being tested in trial NCT01989052?

The interventions under investigation include: Lomustine (DRUG), CTO (DRUG).

Who is sponsoring clinical trial NCT01989052?

This trial is sponsored by Annick Desjardins, which has 9 total clinical trials registered on ClinicalTrials.gov.

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.