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

Completed · Phase 1

Conditions studied: Neoplasms

In brief

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.

Key facts

Study ID: NCT00030173
Run by: Bristol-Myers Squibb
People needed: 45
Starts: 2001-10-01
Expected to finish: 2003-06-01
Last updated by the study team: 2009-01-08

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

UCLA Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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