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

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.

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Key information

Conditions

Malignant Glioma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Gimatecan® (ST 1481)

Drug

Sponsors and collaborators

Lead sponsor

Sigma-Tau Research, Inc.

Industry

Collaborators

Rhode Island Hospital

Registry information

Official study title

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

Important dates

Study start: 2002
Study completion: 2005
First posted: Apr 8, 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