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

Completed · Phase 1

Conditions studied: Solid Malignancies

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

Key facts

Study ID

NCT00033202

Run by

Sigma-Tau Research, Inc.

People needed

30

Starts

2002-03-01

Expected to finish

2005-02-01

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/cytologically proven advanced solid tumors
• 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

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Rhode Island Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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