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

This study is currently recruiting participants.

Verified by Sigma-Tau Research, Inc., January 2002

Sponsors and Collaborators:	Sigma-Tau Research, Inc. Rhode Island Hospital Dana-Farber Cancer Institute
Information provided by:	Sigma-Tau Research, Inc.
ClinicalTrials.gov Identifier:	NCT00033202

Purpose

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.

Condition	Intervention	Phase
Solid Malignancies	Drug: Gimatecan® (ST-1481)	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Gimatecan Camptothecin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Phase I Study of Oral ST1481 Administered Once Weekly Every 3 Out 4 Weeks in Patients With Advanced Solid Malignancies.

Further study details as provided by Sigma-Tau Research, Inc.:

Estimated Enrollment:	30
Study Start Date:	March 2002
Estimated Study Completion Date:	September 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00033202

Contacts

Contact: Dan Zhang, MD

(301) 941-1041

dan.zhang@st-research.com

Locations

United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Andrew Zhu, MD 617-726-8743 azhu@partners.org
Contact: Jeffrey W. Clark, MD (617)726-8743 jclark@partners.org
Dana-Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Andrew Zhu, MD 617-726-8743 azhu@partners.org
Contact: Jeffrey W. Clark, MD (617) 726 8743 jclark@partners.org
United States, Rhode Island
Rhode Island Hospital	Recruiting
Providence, Rhode Island, United States, 02903
Contact: Neal Ready, MD, PhD 401-444-5391 neready@lifespan.org
Contact: Paul Calabresi, MD (401) 444-8977 PCalabresi1@Lifespan.org

Sponsors and Collaborators

Sigma-Tau Research, Inc.

Rhode Island Hospital

Dana-Farber Cancer Institute

More Information

Study ID Numbers:	ST-01-401
Study First Received:	April 9, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00033202
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sigma-Tau Research, Inc.:

Solid Tumor
Camptothecin
Pharmacokinetics

Study placed in the following topic categories:

Camptothecin

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on January 16, 2009