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

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.

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Key information

Conditions

Solid Malignancies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gimatecan® (ST-1481)

Drug

Sponsors and collaborators

Lead sponsor

Sigma-Tau Research, Inc.

Industry

Collaborators

Dana-Farber Cancer Institute
Rhode Island Hospital

Registry information

Official study title

Phase I Study of Oral ST1481 Administered Once Weekly Every 3 Out 4 Weeks in Patients With Advanced Solid Malignancies.

Important dates

Study start: 2002
Study completion: 2005
First posted: Apr 10, 2002
Registry last updated: Jun 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed