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

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.

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Key information

Conditions

Neoplasms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UCLA Medical Center

Los Angeles, California, 90095-7059, United States

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Epothilone D (KOS-862)

Drug

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1, Dose Escalation Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Epothilone D in Patients With Advanced Solid Tumors

Important dates

Study start: 2001
Study completion: 2003
First posted: Feb 8, 2002
Registry last updated: Jan 8, 2009

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