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NCT00033202 Clinical Trial

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

Solid Malignancies Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00033202
Other study ID # ST 01-401
Secondary ID
Status Completed
Phase Phase 1
First received April 9, 2002
Last updated June 2, 2009
Start date March 2002
Est. completion date February 2005

Study information
Verified date June 2009
Source Sigma-Tau Research, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date February 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Gimatecan® (ST-1481)

Locations
Country Name City State
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Rhode Island Hospital Providence Rhode Island

Sponsors (3)
Lead Sponsor Collaborator
Sigma-Tau Research, Inc. Dana-Farber Cancer Institute, Rhode Island Hospital

Country where clinical trial is conducted

United States, 

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