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

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ClinicalTrials.gov Identifier: NCT00033202
Recruitment Status : Completed
First Posted : April 10, 2002
Last Update Posted : June 3, 2009
Sponsor:
Collaborators:
Rhode Island Hospital
Dana-Farber Cancer Institute
Information provided by:
Sigma-Tau Research, Inc.

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.

Condition or disease Intervention/treatment Phase
Solid Malignancies Drug: Gimatecan® (ST-1481) Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : March 2002
Actual Study Completion Date : February 2005




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00033202     History of Changes
Other Study ID Numbers: ST 01-401
First Posted: April 10, 2002    Key Record Dates
Last Update Posted: June 3, 2009
Last Verified: June 2009

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

Additional relevant MeSH terms:
Neoplasms