This is an Early Study to Investigate the Effect of Gimatecan® in Adults With Solid Tumor

This study has been completed.
Sponsor:
Collaborators:
Rhode Island Hospital
Dana-Farber Cancer Institute
Information provided by:
Sigma-Tau Research, Inc.
ClinicalTrials.gov Identifier:
NCT00033202
First received: April 9, 2002
Last updated: June 2, 2009
Last verified: June 2009

April 9, 2002
June 2, 2009
March 2002
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Complete list of historical versions of study NCT00033202 on ClinicalTrials.gov Archive Site
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This is an Early Study to Investigate the Effect of Gimatecan® in Adults With Solid Tumor
Phase I Study of Oral ST1481 Administered Once Weekly Every 3 Out 4 Weeks in Patients With Advanced Solid Malignancies.

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, when given as a capsule, rather than by intravenous injection.

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Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Malignancies
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
30
February 2005
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Inclusion criteria:

  • Histologically/cytologically proven advanced solid tumors
  • 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
 
NCT00033202
ST 01-401
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Sigma-Tau Research, Inc.
  • Rhode Island Hospital
  • Dana-Farber Cancer Institute
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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