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

• Status: Completed
• Trial end date: 2005-02-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sigma-Tau Research, Inc.
• Collaborators: Dana-Farber Cancer Institute; Rhode Island Hospital

Criteria

Inclusion criteria:

• Histologically/cytologically proven advanced solid tumors

• 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