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NCT00629343 · ClinicalTrials.gov registry record · Phase 1

Phase I Dose-Escalation Study Of Azacitidine In Combination With Temozolomide

A Phase 1 study of Soft Tissue Sarcoma and Mesothelioma, sponsored by Columbia University.

Completed
Registry status
Phase 1
Development phase
27
Enrollment target
1
Study location

NCT00629343 is a Phase 1 study of Soft Tissue Sarcoma and Mesothelioma that has completed, run by Columbia University. The registered enrollment target is 27 participants, below the 78-participant average among 55 other Soft Tissue Sarcoma trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00629343, a Phase 1 study of Soft Tissue Sarcoma and Mesothelioma, has completed, sponsored by Columbia University.

COMPLETED
Registry status
Phase 1
Development phase
27 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to determine safety and toxicity for the combination of Temozolomide and Azacitidine in the treatment of Advanced Soft Tissue Sarcoma or Malignant Mesothelioma. This is a single-center, open-label, single-arm Phase I dose-escalation trial. Patients will be evaluated with complete history and physical as well as laboratory studies (complete blood count, metabolic panel, liver function tests), biopsy, and imaging of all sites of measurable disease. This study will be conducted over the course of 3 years.

Interventions

  • DRUG Azacitidine
  • DRUG Temozolomide

Study Locations (1)

New York

  • Columbia University Medical Center - New York

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2007-10
Est. Completion 2012-10
Phase Phase 1

Sponsor

Columbia University

958 total trials

What the Registry Record Tells You About NCT00629343

The ClinicalTrials.gov registry entry for NCT00629343 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 78-participant average among 55 other Soft Tissue Sarcoma trials with a reported enrollment target (65% lower). The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Soft Tissue Sarcoma appearing as the primary indexed condition, and to 2 interventions - of which Azacitidine is the first listed.

NCT00629343 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT00629343 about?

NCT00629343 is a clinical study titled "Phase I Dose-Escalation Study Of Azacitidine In Combination With Temozolomide". The purpose of this study is to determine safety and toxicity for the combination of Temozolomide and Azacitidine in the treatment of Advanced Soft Tissue Sarcoma or Malignant Mesothelioma. This is a single-center, open-label, single-arm Phase I dose-escalation trial. Patients will be evaluated with...

What is the current status of trial NCT00629343?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2007-10. Estimated completion is 2012-10.

What conditions does trial NCT00629343 study?

This clinical trial studies the following conditions: Soft Tissue Sarcoma, Mesothelioma.

What interventions are being tested in trial NCT00629343?

The interventions under investigation include: Azacitidine (DRUG), Temozolomide (DRUG).

Who is sponsoring clinical trial NCT00629343?

This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00629343 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

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.