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

This study has been completed.
Sponsor:
Collaborator:
Rhode Island Hospital
Information provided by:
Sigma-Tau Research, Inc.
ClinicalTrials.gov Identifier:
NCT00032903
First received: April 5, 2002
Last updated: June 2, 2009
Last verified: June 2009

April 5, 2002
June 2, 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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Completed
59
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00032903
ST 01-402
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Sigma-Tau Research, Inc.
Rhode Island Hospital
Not Provided
Sigma-Tau Research, Inc.
June 2009

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