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
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Oral ST1481 Administered Once Weekly Every 3 Out 4 Weeks in Patients With Advanced Solid Malignancies.

Resource links provided by NLM:


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

Estimated Enrollment: 30
Study Start Date: March 2002
Study Completion Date: February 2005
  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

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Sigma-Tau Research, Inc.
Rhode Island Hospital
Dana-Farber Cancer Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00033202     History of Changes
Other Study ID Numbers: ST 01-401
Study First Received: April 9, 2002
Last Updated: June 2, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Sigma-Tau Research, Inc.:
Solid Tumor
Camptothecin
Pharmacokinetics

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014