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NCT00032903 Clinical Trial

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

Malignant Glioma Clinical Trial

Official title:
Oral ST1481 in Adults With Malignant Glioma: a Phase I-II Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00032903
Other study ID # ST 01-402
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received April 5, 2002
Last updated June 2, 2009
Start date March 2002
Est. completion date October 2005

Study information
Verified date June 2009
Source Sigma-Tau Research, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 59
Est. completion date October 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Gimatecan® (ST 1481)

Locations
Country Name City State
United States Rhode Island Hospital Providence Rhode Island

Sponsors (2)
Lead Sponsor Collaborator
Sigma-Tau Research, Inc. Rhode Island Hospital

Country where clinical trial is conducted

United States, 

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