A Trial to Evaluate Epothilone D in Patients With Advanced Solid Tumors

This study has been completed.

First Received on February 7, 2002. Last Updated on January 7, 2009 History of Changes

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00030173

Purpose

Epothilone D represents one of a class of cytotoxic macrolides capable of causing mitotic arrest by stabilizing tubulin polymerization. Since microtubules are essential for mitosis, motility, secretion and proliferation, the observed antitumor effects of epothilones have been attributed to their ability to initiate cell death by inhibiting such processes. Epothilone D has demonstrated in vitro cytotoxic activity in a panel of human cell lines, equipotent to that of paclitaxel. In vivo, Epothilone D has also shown significant antitumor activity in a range of xenograft models, including paclitaxel-resistant xenografts. Epothilone D is more potent than paclitaxel in cell lines that demonstrate multiple drug resistant activity overexpressing p-glycoprotein.

Condition	Intervention	Phase
Neoplasms	Drug: Epothilone D (KOS-862)	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 1, Dose Escalation Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Epothilone D in Patients With Advanced Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Desoxyepothilone B

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Estimated Enrollment:	45
Study Start Date:	October 2001
Study Completion Date:	June 2003

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of histologically documented, advanced stage, primary or metastatic adult solid tumors that are refractory to standard therapy or for which no curative standard therapy exists. This includes but is not limited to cancers of the breast, ovary, head and neck, esophagus, lung, gastrointestinal tract, and sarcomas.
Evidence of radiographically measurable or evaluable disease.

Exclusion Criteria:

Pre-existing peripheral neuropathy of CTC Grade > 2 due to any cause.
Documented hypersensitivity reaction (CTC Grade > 2) to prior paclitaxel or other therapy containing Cremophor.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00030173

Locations

United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095-7059

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00030173 History of Changes
Obsolete Identifiers:	NCT00033501
Other Study ID Numbers:	KOS-101
Study First Received:	February 7, 2002
Last Updated:	January 7, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Epothilone D
tubulin polymerization

Additional relevant MeSH terms:

Neoplasms
Epothilones
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012