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

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ClinicalTrials.gov Identifier: NCT00032903
Recruitment Status : Completed
First Posted : April 8, 2002
Last Update Posted : June 3, 2009
Sponsor:
Collaborator:
Rhode Island Hospital
Information provided by:
Sigma-Tau Research, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Malignant Glioma Drug: Gimatecan® (ST 1481) Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 59 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oral ST1481 in Adults With Malignant Glioma: a Phase I-II Clinical Trial
Study Start Date : March 2002
Actual Study Completion Date : October 2005

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00032903


Locations
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Sigma-Tau Research, Inc.
Rhode Island Hospital

ClinicalTrials.gov Identifier: NCT00032903     History of Changes
Other Study ID Numbers: ST 01-402
First Posted: April 8, 2002    Key Record Dates
Last Update Posted: June 3, 2009
Last Verified: June 2009

Keywords provided by Sigma-Tau Research, Inc.:
Malignant Glioma, Camptothecin, Pharmacokinetics

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue