Last updated: 11/07/2018 00:45:58
A Phase I Study to Determine the Maximum Tolerated Dose of Topotecan Following Oral Administration over 5, 10 or 21 Days in Patients with Malignant Solid Tumors
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Phase I Study to Determine the Maximum Tolerated Dose of Topotecan Following Oral Administration over 5, 10 or 21 Days in Patients with Malignant Solid Tumors
Trial description: A Phase I Study to Determine the Maximum Tolerated Dose of Topotecan Following Oral Administration over 5, 10 or 21 Days in Patients with Malignant Solid Tumors
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, Gerrits CJ, Eckardt JR, Schellens JH, Burris HA, Planting AS, Rodriguez GI, Loos WJ, Hudson I, Broom C, Verweij J, Von Hoff DD. Phase I and pharmacologic study of oral topotecan administered twice daily for 21 days to adult patients with solid tumors. J Clin Oncol. 1997;15(3): 1087-1093.
Gerrits CJ, Burris H, Schellens JH, Planting AS, Van den Burg MEL, Rodriguez GI, Van Beurden V, Loos WJ, Hudson I, Fields S, Verweij J, Von Hoff DD. Five days of oral topotecan (hycamtin®), a phase I and pharmacological study in adult patients with solid tumours. Eur J Cancer. 1998; 34(7): 1030-1035.
Gerrits CJ, Schellens JH, Burris H, Eckardt JR, Planting AS, van der Burg ME, Rodriguez GI, Loos WJ, van Beurden V, Hudson I, Von Hoff DD, Verweij J. A comparison of clinical pharmacodynamics of different administration schedules of oral topotecan (Hycamtin). Clin Cancer Res. 1999; 5(1): 69-75.
Medical condition
Lung Cancer, Small Cell
Product
topotecan
Collaborators
Not applicable
Study date(s)
April 1994 to July 1997
Type
Not applicable
Phase
1
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
1997-29-07
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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