Clinical Study of Ixabepilone Administered as a 24 Hour Infusion in Patients With Solid Malignancies. - Full Text View

Purpose

The purpose of this study is to determine the dose limiting toxicities, minimum tolerated dose and recommended dose for Phase II studies.

Condition	Intervention	Phase
Solid Malignancies	Drug: Ixabepilone	Phase I

MedlinePlus related topics:

Cancer

ChemIDplus related topics:

Ixabepilone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Official Title:	Phase I Study of Ixabepilone Administered as a 24-Hour Infusion in Patients With Advanced Solid Malignancies

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

To Define the DLT, MTD, and recommended dose for Phase II. [ Time Frame: Measures will be taken at Cycle 01(Dose Escalation) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability of Cremophor free infusion of ixabepilone given over 24 hours. [ Time Frame: Done throughout the study. ] [ Designated as safety issue: Yes ]

Enrollment:	71
Study Start Date:	September 2005
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A1: Experimental	Drug: Ixabepilone Intravenous Infusion, IV, 10, 20, 30, 35, 40 & 45 mg/m2, once every 21 days (1 cycle), up to 9 cycles

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162136

Locations


United States, Maryland
	University Of Maryland
	Baltimore, Maryland, United States, 21201

United States, New Jersey
	The Cancer Institute Of New Jersey
	New Brunswick, New Jersey, United States, 08901

United States, Ohio
	Cleveland Clinic Foundation
	Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators


Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA163-085
First Received:	September 9, 2005
Last Updated:	August 5, 2008
ClinicalTrials.gov Identifier:	NCT00162136
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Epothilones

Additional relevant MeSH terms:

Neoplasms

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Mitosis Modulators

Tubulin Modulators

Antimitotic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 19, 2008

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00162136