Last updated: 11/07/2018 00:43:50

Phase I study of topotecan

GSK study ID
104864/005
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Phase I study of topotecan
Trial description: Phase I study of topotecan
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:
5 days of once daily oral topotecan, a phase 1 and pharmacologic study in adults. C.J.H. Gerrits, H. Burris J. H. M. Schellens A. S. T. Planting M. E. L. v. d. Burg W. J. Loos C. Broom 1. Hudson J. Verweij D. D. von Hoff. 21st Congress of the European Society for Medical Oncology 11/1/1996 Vienna; Austria
Verweij J, Lund B, Beijnen J, Planting A, de Boer-Dennert M, Koier I, Rosing H, Hansen H. Phase I and pharmacokinetics study of topotecan, a new topoisomerase I inhibitor. Ann Oncol. 1993;4(8):673-678.
van Warmerdam LJ. Verweij J. Schellens JH. Rosing H. Davies BE. de Boer-Dennert M. Maes RA. Beijnen JH. Pharmacokinetics and pharmacodynamics of topotecan administered daily for 5 days every 3 weeks. Cancer Chemotherapy & Pharmacology. 35(3):237-45, 1995.
Medical condition
Solid Tumours
Product
topotecan
Collaborators
Not applicable
Study date(s)
October 1990 to November 1992
Type
Not applicable
Phase
1

Participation criteria

Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable

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
1992-13-11

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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Access to clinical trial data by researchers
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Phase I study of topotecan, Trial ID 104864%2F005 | GSK