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NCT00158886 · ClinicalTrials.gov registry record · Phase 1
Oral Topotecan As A Radiosensitizing Agent In Rectal Cancer
A Phase 1 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT00158886 is a Phase 1 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 26 participants.
The verdict
NCT00158886, a Phase 1 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
Patients with rectal cancer who are candidates for pre-operative radiation therapy may be enrolled in the Phase I, single center study. Patients will have a full blood count, biochemistry, urinalysis, and ECG for safety evaluation. Sequential cohorts of three patients will be given increasing doses of oral topotecan and fixed doses of concurrent radiation (45 Gy) over five weeks. The starting dose of oral topotecan is 0.25 mg/m2 to be concomitantly administered with radiation (45 Gy) x 5 days every week unless the radiation is interrupted for Holidays/Weekends or toxicity requiring treatment delays occurs. A total of 25 doses are planned.
Interventions
- DRUG Topotecan
- RADIATION Radiation therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2001-11-08 |
| Est. Completion | 2006-08-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00158886
The ClinicalTrials.gov registry entry for NCT00158886 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Topotecan is the first listed.
NCT00158886 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00158886 about?
NCT00158886 is a clinical study titled "Oral Topotecan As A Radiosensitizing Agent In Rectal Cancer". Patients with rectal cancer who are candidates for pre-operative radiation therapy may be enrolled in the Phase I, single center study. Patients will have a full blood count, biochemistry, urinalysis, and ECG for safety evaluation. Sequential cohorts of three patients will be given increasing doses ...
What is the current status of trial NCT00158886?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2001-11-08. Estimated completion is 2006-08-11.
What interventions are being tested in trial NCT00158886?
The interventions under investigation include: Topotecan (DRUG), Radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT00158886?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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