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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00032903
Recruitment Status : Completed
First Posted : April 8, 2002
Last Update Posted : June 3, 2009
Information provided by:

April 5, 2002
April 8, 2002
June 3, 2009
March 2002
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Complete list of historical versions of study NCT00032903 on ClinicalTrials.gov Archive Site
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This is an Early Study to Investigate the Effect of Gimatecan® in Adults With Malignant Glioma.
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.
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Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Malignant Glioma
Drug: Gimatecan® (ST 1481)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
October 2005
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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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
ST 01-402
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Sigma-Tau Research, Inc.
Rhode Island Hospital
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Sigma-Tau Research, Inc.
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP