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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: Clinical Trial Phase 1 study, sponsored by GlaxoSmithKline.
NCT00158886 is a Phase 1 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
Why NCT00158886 stopped before completion
NCT00158886 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 2 interventions - of which Topotecan is the first listed.
NCT00158886 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00158886's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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