Last updated: 11/07/2018 00:52:24
An open-label, multicentre, randomised, phase III comparator study of oral topotecan versus intravenous topotecan for second-line therapy in patients with SCLC who have relapsed greater than or equal to 90 days after completion of first-line therapy
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-label, multicentre, randomised, phase III comparator study of oral topotecan versus intravenous topotecan for second-line therapy in patients with SCLC who have relapsed greater than or equal to 90 days after completion of first-line therapy
Trial description: An open-label, multicentre, randomised, phase III comparator study of oral topotecan versus intravenous topotecan for second-line therapy in patients with SCLC who have relapsed greater than or equal to 90 days after completion of first-line therapy
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:
Eckardt JR, et.al. Single agent oral topotecan (PO) versus intravenous topotecan (IV) in patients (pts) with chemosensitive small cell lung cancer (SCLC). An international phase III study Proc Am Soc Clin Oncol 22, pg 619 abstract 2488, 2003
Medical condition
Lung Cancer, Small Cell
Product
topotecan
Collaborators
Not applicable
Study date(s)
December 1998 to May 2002
Type
Not applicable
Phase
3
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
Clinical study report
Available language(s): English
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
2002-17-05
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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