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Phase II Study of Ixabepilone in Metastatic Breast Cancer and Its Effects on the Ultrastructure of Neurons

NCT00627978 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2018-06-26

Study results available
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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.

Conditions

Interventions

DRUG

ixabepilone

ixabepilone 40 mg/m2 Q3w over 3 hours

Sponsors & Collaborators

Principal Investigators

  • Linda Vahdat, MD · Weill Medical College of Cornell University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00627978 on ClinicalTrials.gov