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NCT00422097 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study of Oral Ixabepilone in Subjects With Advanced Cancer
A Phase 1 study of Cancer, sponsored by R-Pharm.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 2
- Study locations
NCT00422097: Completed Phase 1 study of Cancer, sponsored by R-Pharm.
NCT00422097 is a Phase 1 study of Cancer that has completed, run by R-Pharm. The registered enrollment target is 40 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00422097, a Phase 1 study of Cancer, has completed, sponsored by R-Pharm.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study will determine the maximum tolerated dose of oral ixabepilone administered for 5 successive days every 21 days in participants with advanced cancer. The safety, tolerability, and pharmacokinetics of ixabepilone in the body will be studied. In addition, this study will assess preliminary evidence of the effect of food and famotidine on the pharmacokinetics of oral ixabepilone.
Primary Outcome
MTD is based on Cycle 1 data only and defined as the maximum dose that can be administered to 6 participants with no more than 1 experiencing a dose-limiting toxicity (DLT) (or fewer than one third of participants if more than 6 receive treatment) with at least 2 participants experiencing a DLT at the next higher dose level. DLT=an event, such as neutropenia; thrombocytopenia; Gr 3 or 4 nausea or diarrhea; Gr 3 fatigue or asthenia; transient arthralgia or recalcitrant myalgia; and prolonged reco
Conditions Studied
Interventions
- DRUG Ixabepilone, 5 mg/d
- DRUG Ixabepilone, 10 mg/d
- DRUG Ixabepilone, 15 mg/d
- DRUG Ixabepilone, 20 mg/d
- DRUG Ixabepilone, 25 mg/d
Study Locations (2)
District of Columbia
- Georgetown University Medical Center Lombardi Cancer Center - Washington D.C.
Michigan
- Wayne State University (Hwcrc) - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2007-01 |
| Est. Completion | 2011-04 |
| Phase | Phase 1 |
What the finished NCT00422097 record still lists
NCT00422097 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Cancer appearing as the primary indexed condition, and to 5 interventions - of which Ixabepilone, 5 mg/d is the first listed.
NCT00422097 reports a single indexed study location in District of Columbia, Michigan.
Frequently Asked Questions
What is clinical trial NCT00422097 about?
NCT00422097 is a clinical study titled "A Phase I Study of Oral Ixabepilone in Subjects With Advanced Cancer". This study will determine the maximum tolerated dose of oral ixabepilone administered for 5 successive days every 21 days in participants with advanced cancer. The safety, tolerability, and pharmacokinetics of ixabepilone in the body will be studied. In addition, this study will assess preliminary e...
What is the current status of trial NCT00422097?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2007-01. Estimated completion is 2011-04.
What conditions does trial NCT00422097 study?
This clinical trial studies the following conditions: Cancer.
What interventions are being tested in trial NCT00422097?
The interventions under investigation include: Ixabepilone, 5 mg/d (DRUG), Ixabepilone, 10 mg/d (DRUG), Ixabepilone, 15 mg/d (DRUG), Ixabepilone, 20 mg/d (DRUG), Ixabepilone, 25 mg/d (DRUG).
Who is sponsoring clinical trial NCT00422097?
This trial is sponsored by R-Pharm, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00422097 being conducted?
This trial has 2 study locations across District of Columbia, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00422097's enrollment target sits among peer trials
40 461st of 615 higher than 146 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cancer 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.
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