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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00422097
The ClinicalTrials.gov registry entry for NCT00422097 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower). The listed sponsor is R-Pharm, which has 19 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.