CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 124 enrolled
Drug / intervention
ixabepilonedrug
Likely dose
ixabepilone given IV on a weekly scheduleAI-extracted
Key inclusion· 6
  • ✓Histologically confirmed adenocarcinoma of the prostate with metastatic disease
  • ✓Evidence of disease progression (new lesions, enlarging lesions, or rising PSA within past 4 weeks)
  • ✓Failed prior bilateral orchiectomy or other primary hormonal therapy
  • ✓ECOG performance status 0-2
Key exclusion· 7
  • ✕Brain metastases or carcinomatous meningitis
  • ✕Other malignancy within past 5 years (except curatively treated nonmelanoma skin cancer)
  • ✕Serious medical illness or active infection precluding study participation
  • ✕New York Heart Association class III-IV heart disease, myocardial infarction within past 6 months, active angina, ventricular dysrhythmias or unstable arrhythmia

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00087139
NCT00087139Phase 2Completed
CompareCT.gov

Phase II Study of a Weekly Schedule of BMS-247550 for Patients With Hormone Refractory Prostate Cancer

National Cancer Institute (NCI)·interventional·Posted Jul 12, 2004·Updated May 9, 2014

In Brief

A Phase 2 clinical trial evaluating ixabepilone for Adenocarcinoma of the Prostate and 2 related conditions. Completed, enrolled 124 participants across 162 sites.

Detailed Summary

Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well ixabepilone works in treating patients with metastatic prostate cancer that has not responded to previous hormone therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage IV Prostate Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 12, 2004
Enrollment StartSep 1, 2004
Primary CompletionApr 1, 2009
Study CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 22.0 years ago

Interventions

ixabepilonedrug

Given IV