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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00267488 |
The purpose of this study is to find out if Hycamtin given weekly is safe and effective for treating your endometrial cancer.
Condition | Intervention | Phase |
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Endometrial Cancer |
Drug: topotecan |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | An Open-Label, Phase II, Multicenter Study of Intravenous Weekly Topotecan in Subjects With Recurrent or Persistent Endometrial Cancer |
Enrollment: | 70 |
Study Start Date: | October 2005 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subject must have at least one measurable lesion according to GOG-modified RECIST criteria.
Subject of childbearing potential must be practicing adequate contraception [e.g., oral contraceptives, diaphragm plus spermicide, or intrauterine device (IUD)] or show documented complete abstinence from intercourse for at least three months prior to study start. The same contraceptive method should be used throughout the study and continue for at least four weeks after the end of the study. A subject will be considered of childbearing potential if not surgically sterile or post-menopausal (i.e., documented absence of menses for one year prior to entry into the study).
14. Subject must have screening laboratory criteria as follows:
Clcreat (mL/min) = (140-age [yr] x body wt [kg] x 0.85 72 x serum creatinine [mg/dL] OR Clcreat (mL/min) = 1.05 x (140-age [yr] x body wt [kg] serum creatinine [μmol/L]
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria are met:
Study Director: | GSK Clinical Trials, MD, PhD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 100414 |
Study First Received: | December 20, 2005 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00267488 |
Health Authority: | United States: Food and Drug Administration; Canada: Canadian Institutes of Health Research; Hungary: National Institute of Pharmacy |
Hycamtin topotecan endometrial cancer |
Genital Diseases, Female Endometrial Neoplasms Genital Neoplasms, Female Uterine Diseases Uterine Neoplasms |
Urogenital Neoplasms Endometrial cancer Topotecan Recurrence |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Pharmacologic Actions |