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NCT00382733 · ClinicalTrials.gov registry record · Phase 1
Oral Topotecan to Treat Recurrent or Persistent Solid Tumors
A Phase 1 study, sponsored by Accelerated Community Oncology Research Network.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT00382733: Completed Phase 1 study, sponsored by Accelerated Community Oncology Research Network.
NCT00382733 is a Phase 1 study that has completed, run by Accelerated Community Oncology Research Network. 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
NCT00382733, a Phase 1 study, has completed, sponsored by Accelerated Community Oncology Research Network.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effectiveness of oral topotecan and how well the chemotherapy is tolerated (any side effects) when it is given in different dose levels. The study will also collect information on how the medication is being broken down and absorbed in the body and how quality of life is affected during treatment.
Primary Outcome
The MTD of metronomic oral topotecan was determined using a standard 3+3 dose escalation cohort design. The total sample and the number of subjects who receive each dose in this design depends on the frequency of dose limiting toxicities (DLTs)at each dose level. If 0 out of 3 subjects experience a DLT at a given dose level, 3 subjects will be enrolled at the next higher dose level. If greater than or equal to 2 subjects experience a DLT at a given dose level, dose escalation will be stopped. If
Interventions
- DRUG Oral Topotecan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2006-11 |
| Est. Completion | 2011-03 |
| Phase | Phase 1 |
What the finished NCT00382733 record still lists
NCT00382733 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 1 intervention - of which Oral Topotecan is the first listed.
NCT00382733 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00382733 about?
NCT00382733 is a clinical study titled "Oral Topotecan to Treat Recurrent or Persistent Solid Tumors". The purpose of this study is to evaluate the effectiveness of oral topotecan and how well the chemotherapy is tolerated (any side effects) when it is given in different dose levels. The study will also collect information on how the medication is being broken down and absorbed in the body and how qu...
What is the current status of trial NCT00382733?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2006-11. Estimated completion is 2011-03.
What interventions are being tested in trial NCT00382733?
The interventions under investigation include: Oral Topotecan (DRUG).
Who is sponsoring clinical trial NCT00382733?
This trial is sponsored by Accelerated Community Oncology Research Network, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00382733'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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