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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
  Purpose

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 Intervention Phase
Malignant Glioma
Drug: Gimatecan® (ST 1481)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oral ST1481 in Adults With Malignant Glioma: a Phase I-II Clinical Trial

Resource links provided by NLM:


Further study details as provided by Sigma-Tau Research, Inc.:

Estimated Enrollment: 59
Study Start Date: March 2002
Study Completion Date: October 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00032903     History of Changes
Other Study ID Numbers: ST 01-402
Study First Received: April 5, 2002
Last Updated: June 2, 2009
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 27, 2014