CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
ixabepilonedrug
Likely dose
ixabepilone 40 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00627978
NCT00627978Phase 2Completed
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Phase II Study of Ixabepilone in Patients With Metastatic Breast Cancer and a Prospective Evaluation of Its Effects on the Ultrastructure of Neurons

Weill Medical College of Cornell University·interventional·Posted Mar 4, 2008·Updated Jun 26, 2018

In Brief

A Phase 2 clinical trial evaluating ixabepilone for Metastatic Breast Cancer. Completed, enrolled 15 participants across 1 site.

Detailed Summary

Primary Objectives * Assess ultrastructure changes in dermal myelinated nerves of patients who receive ixabepilone chemotherapy * Detailed characterization of peripheral neuropathy in patients who receive ixabepilone Secondary Objectives * Clinical benefit rate * Time to progression ( TTP) * Toxicity * Exploratory studies: * Relation of MDR 1 and TRKA polymorphisms to evolution of ultrastructural neurologic changes observed in neurons. * Relation of NGF, IL8, and IL10 to the development of clinical symptoms and ultrastructural changes in neurons.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Breast Cancer
CountriesUnited States
CollaboratorsBristol-Myers Squibb

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 4, 2008
Enrollment StartNov 1, 2007
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 18.3 years ago

Interventions

ixabepilonedrug

ixabepilone 40 mg/m2 Q3w over 3 hours