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NCT00611468 · ClinicalTrials.gov registry record · Phase 1
Phase I, Dosage-finding and PK Study of IV Topotecan and Erlotinib With Refractory Solid Tumors
A Phase 1 study, sponsored by Accelerated Community Oncology Research Network.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT00611468: Completed Phase 1 study, sponsored by Accelerated Community Oncology Research Network.
NCT00611468 is a Phase 1 study that has completed, run by Accelerated Community Oncology Research Network. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00611468, a Phase 1 study, has completed, sponsored by Accelerated Community Oncology Research Network.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study Summary
The purpose of this research study is to determine the best dose of the combination of two approved drugs, intravenous topotecan and oral erlotinib.
Primary Outcome
The MTD of topotecan was determined using a standard 3 + 3 dose escalation cohort design. The total sample and the number of patients who receive each dose in this design depends on the frequency of dose limiting toxicities (DLT) at each dosage. If 0 out of 3 patients experience a DLT at a given dosage level, 3 patients will be enrolled at the next dosage level. If greater than or equal to 2 patients experience a DLT at a given dosage level, dosage escalation will be stopped. If 1 out of 3 patie
Interventions
- DRUG Topotecan
- DRUG Erlotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2006-06 |
| Est. Completion | 2009-08 |
| Phase | Phase 1 |
What the finished NCT00611468 record still lists
NCT00611468 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 2 interventions - of which Topotecan is the first listed.
NCT00611468 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00611468 about?
NCT00611468 is a clinical study titled "Phase I, Dosage-finding and PK Study of IV Topotecan and Erlotinib With Refractory Solid Tumors". The purpose of this research study is to determine the best dose of the combination of two approved drugs, intravenous topotecan and oral erlotinib.
What is the current status of trial NCT00611468?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2006-06. Estimated completion is 2009-08.
What interventions are being tested in trial NCT00611468?
The interventions under investigation include: Topotecan (DRUG), Erlotinib (DRUG).
Who is sponsoring clinical trial NCT00611468?
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 NCT00611468's enrollment target sits among peer trials
29 1440th of 2000 higher than 554 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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