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NCT00162136 · ClinicalTrials.gov registry record · Phase 1
Clinical Study of Ixabepilone Administered as a 24 Hour Infusion in Patients With Solid Malignancies.
A Phase 1 study, sponsored by R-Pharm.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT00162136: Completed Phase 1 study, sponsored by R-Pharm.
NCT00162136 is a Phase 1 study that has completed, run by R-Pharm. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00162136, a Phase 1 study, has completed, sponsored by R-Pharm.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the dose limiting toxicities, minimum tolerated dose and recommended dose for Phase II studies.
Primary Outcome
Dose limiting toxicities=any of the following events attributed to Ixabepilone occuring during the first cycle: grade 3/4 nausea, vomiting, or diarrhea despite medical intervention and/or prophylaxis; other Grade ≥3 nonhematological toxicity; any toxicity requiring study therapy discontinuation; delayed recovery from study therapy-related toxicity which delays scheduled re-treatment for \>14 days; Grade 4 neutropenia for ≥5 consecutive days; grade 3/4 neutropenia with sepsis or a fever ≥38.5 C;
Interventions
- DRUG Ixabepilone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2005-09 |
| Est. Completion | 2008-07 |
| Phase | Phase 1 |
What the finished NCT00162136 record still lists
NCT00162136 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 1 intervention - of which Ixabepilone is the first listed.
NCT00162136 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00162136 about?
NCT00162136 is a clinical study titled "Clinical Study of Ixabepilone Administered as a 24 Hour Infusion in Patients With Solid Malignancies.". The purpose of this study is to determine the dose limiting toxicities, minimum tolerated dose and recommended dose for Phase II studies.
What is the current status of trial NCT00162136?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2005-09. Estimated completion is 2008-07.
What interventions are being tested in trial NCT00162136?
The interventions under investigation include: Ixabepilone (DRUG).
Who is sponsoring clinical trial NCT00162136?
This trial is sponsored by R-Pharm, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00162136's enrollment target sits among peer trials
35 1258th of 2000 higher than 728 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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