This is an Early Study to Investigate the Effect of Gimatecan® in Adults With Malignant Glioma.

June 2, 2009 updated by: Sigma-Tau Research, Inc.

Oral ST1481 in Adults With Malignant Glioma: a Phase I-II Clinical Trial

Gimatecan® is Sigma-Tau Research's new, potent, oral Topoisomerase I inhibitor. Drugs in this class play a crucial role in destroying DNA replication in tumors. We are conducting this study to determine the Maximum Tolerated Dose of our compound. In addition, we plan to assess the drug's ability to affect the evolution of malignant gliomas, when given as a capsule, rather than by intravenous injection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

59

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Histologically confirmed diagnosis of a recurrent primary malignant glioma
  • Life expectancy of at least 3 months with normal hematological, liver and renal function

Exclusion criteria:

  • Pregnant and lactating patients
  • Participation in any investigating drug study within 4 weeks preceding treatment start or concurrent treatment with any other anti-cancer therapy
  • Gastrointestinal dysfunction that could alter absorption or motility

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sigma-Tau Research, Inc.

Collaborators

Rhode Island Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

April 5, 2002

First Submitted That Met QC Criteria

April 5, 2002

First Posted (Estimate)

April 8, 2002

Study Record Updates

Last Update Posted (Estimate)

June 3, 2009

Last Update Submitted That Met QC Criteria

June 2, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ST 01-402

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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