Last updated: 11/07/2018 00:45:18
An open, multicentre, Phase II study of intravenous topotecan, given as 5 daily doses every 21 days, in advanced epithelial ovarian cancer
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: An open, multicentre, Phase II study of intravenous topotecan, given as 5 daily doses every 21 days, in advanced epithelial ovarian cancer
Trial description: An open, multicentre, Phase II study of intravenous topotecan, given as 5 daily doses every 21 days, in advanced epithelial ovarian cancer
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Creemers GJ et.al. Topotecan, an active drug in the second-line treatment of epithelial ovarian cancer: results of a large European phase II study J Clin Oncol 14, 3056-3061, 1996.
Ninth NCI-EORTC Symposium on New Drugs in Cancer Therapy, 12-15 March 1996, Amsterdam, Abstract 474.
Pharmacokinetics and pharmacodynamics of topotecan given on a daily-times-five schedule in phase ii clinical trials using a limited-sampling procedure. van Warmerdam, L. J., Creemers, G. J., Rodenhuis, S., Rosing, H., de Boer-Dennert, M., Schellens, J. H., ten Bokkel Huinink, W. W., Davies, B. E., Maes, R. A., Verweij, J., and Beijnen, J. H. Cancer Chemother Pharmacol 96; 38(3):254-60
Medical condition
Cancer
Product
topotecan
Collaborators
Not applicable
Study date(s)
May 1993 to October 1996
Type
Not applicable
Phase
2
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
1996-07-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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