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

This study has been completed.

Sponsor:

Collaborators:

Rhode Island Hospital

Dana-Farber Cancer Institute

Information provided by:

Sigma-Tau Research, Inc.

ClinicalTrials.gov Identifier:

NCT00033202

First received: April 9, 2002

Last updated: June 2, 2009

Last verified: June 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	April 9, 2002
Last Updated Date	June 2, 2009
Start Date ^ICMJE	March 2002
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00033202 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	This is an Early Study to Investigate the Effect of Gimatecan® in Adults With Solid Tumor
Official Title ^ICMJE	Phase I Study of Oral ST1481 Administered Once Weekly Every 3 Out 4 Weeks in Patients With Advanced Solid Malignancies.
Brief 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Solid Malignancies
Intervention ^ICMJE	Drug: Gimatecan® (ST-1481)
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	30
Completion Date	February 2005
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00033202
Other Study ID Numbers ^ICMJE	ST 01-401
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Sigma-Tau Research, Inc.
Collaborators ^ICMJE	Rhode Island Hospital Dana-Farber Cancer Institute
Investigators ^ICMJE	Not Provided
Information Provided By	Sigma-Tau Research, Inc.
Verification Date	June 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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