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COMPLETED Phase 1

A Phase I Study of Oral Ixabepilone in Subjects With Advanced Cancer

NCT00422097 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 40 participants
Start Date 2007-01
Est. Completion 2011-04
Phase Phase 1

Sponsor

R-Pharm

7 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is R-Pharm, which has 7 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00422097 reports 2 study locations spanning 2 distinct geographic areas — top geographies include District of Columbia, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00422097?

This trial is sponsored by R-Pharm, which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial