A Study of the Alternative Administration of Ixabepilone and Vinflunine

The purpose of the study is to test how vinflunine interacts with ixabepilone in the human body.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Of Miami Miller School Of Medicine, Miami, Florida, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

ECOG status of 0-1

Exclusion criteria

Inability to tolerate venous access
Brain mets
Severe nerve damage
ANC <2,000/mm3
Platelets <100K
Bilirubin >= 1.5 times the IULN
ALT/AST >= 2.5 times the IULN
Creatinine <50 mL/min
Prior treatment with vinflunine and/or ixabepilone
Strong use of CYPP450 drugs

Treatment and study plan

vinflunine + ixabepilone

Drug

solution for injection, IV, vinflunine: 250 to 320 mg/m2 + ixabepilone: 30 to 40 mg/m2, every 3 wks, variable duration

Primary outcomes

Determine the maximum tolerated dose and describe any dose limiting toxicities of ixabepilone and vinflunine in an alternating regimen.

Time frame: upon occurrence

Secondary outcomes

Determine the overall safety profile, efficacy and rate and extent to which ixabepilone and vinflunine are absorbed or otherwise available to the treatment site in the body.

Time frame: upon occurrence

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Study of the Alternating Administration of Ixabepilone and Vinflunine Every Three Weeks in Patients With Advanced Cancer

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2007
First posted: Aug 10, 2006
Registry last updated: Sep 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed