Last updated: 11/07/2018 00:43:59
An Open Phase I Study to Determine the Maximal Tolerated Dose of Topotecan HCl Administered Intravenously as a Single Dose Every 21 Days in Patients with Solid Tumors Refractory to All Known Forms of Effective 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 Phase I Study to Determine the Maximal Tolerated Dose of Topotecan HCl Administered Intravenously as a Single Dose Every 21 Days in Patients with Solid Tumors Refractory to All Known Forms of Effective Therapy
Trial description: An Open Phase I Study to Determine the Maximal Tolerated Dose of Topotecan HCl Administered Intravenously as a Single Dose Every 21 Days in Patients with Solid Tumors Refractory to All Known Forms of Effective 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:
Wall JG, Burris III HA,Von Hoff DD, et al. A phase I clinical and pharmacokinetic study of the topoisomerase inhibitor topotecan (SK&F 104864) given as an intravenous bolus every 21 days. Anti-Cancer Drugs 1992; 3: 337-345.
Medical condition
Lung Cancer, Small Cell
Product
topotecan
Collaborators
Not applicable
Study date(s)
March 1989 to December 1991
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
1991-31-12
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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