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

Completed · Phase 1/Phase 2

Conditions studied: Malignant Glioma

In brief

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.

Key facts

Study ID

NCT00032903

Run by

Sigma-Tau Research, Inc.

People needed

59

Starts

2002-03-01

Expected to finish

2005-10-01

Last updated by the study team

2009-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed diagnosis of a recurrent primary malignant glioma
• Life expectancy of at least 3 months with normal hematological, liver and renal function

You may not qualify if…

• 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

Where it is running

• Rhode Island Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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