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

NCT00629343 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-06-05

Study results available
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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.

Conditions

Interventions

DRUG

Azacitidine

Azacitidine will be delivered sub-cutaneously for 5 days

DRUG

Temozolomide

Temozolomide will be given starting on day 8 for 5 days at a dose of 200 mg/m2 po qd x 5 days

Sponsors & Collaborators

  • Schering-Plough

    collaborator INDUSTRY

  • Celgene Corporation

    collaborator INDUSTRY

  • Columbia University

    lead OTHER

Principal Investigators

  • Robert N Taub, MD · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00629343 on ClinicalTrials.gov