Back to resultsThis is an Early Study to Investigate the Effect of Gimatecan® in Adults With Malignant Glioma.
Primary Purpose
Malignant Glioma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Gimatecan® (ST 1481)
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Glioma focused on measuring Malignant Glioma, Camptothecin, Pharmacokinetics
Eligibility Criteria
Inclusion criteria: Histologically confirmed diagnosis of a recurrent primary malignant glioma 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
Sites / Locations
- Rhode Island Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00032903
First Posted
April 5, 2002
Last Updated
June 2, 2009
Sponsor
Sigma-Tau Research, Inc.
Collaborators
Rhode Island Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00032903
Brief Title
This is an Early Study to Investigate the Effect of Gimatecan® in Adults With Malignant Glioma.
Official Title
Oral ST1481 in Adults With Malignant Glioma: a Phase I-II Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sigma-Tau Research, Inc.
Collaborators
Rhode Island Hospital
4. Oversight
5. Study Description
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. In addition, we plan to assess the drug's ability to affect the evolution of malignant gliomas, when given as a capsule, rather than by intravenous injection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Glioma
Keywords
Malignant Glioma, Camptothecin, Pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
59 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Gimatecan® (ST 1481)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Histologically confirmed diagnosis of a recurrent primary malignant glioma
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
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
Learn more about this trial
This is an Early Study to Investigate the Effect of Gimatecan® in Adults With Malignant Glioma.
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