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A Trial to Evaluate Epothilone D in Patients With Advanced Solid Tumors
This study has been completed.
Study NCT00030173   Information provided by Bristol-Myers Squibb
First Received: February 7, 2002   Last Updated: January 7, 2009   History of Changes

February 7, 2002
January 7, 2009
October 2001
 
 
 
Complete list of historical versions of study NCT00030173 on ClinicalTrials.gov Archive Site
 
 
 
A Trial to Evaluate Epothilone D in Patients With Advanced Solid Tumors
A Phase 1, Dose Escalation Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of 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.

 
Phase I
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Neoplasms
Drug: Epothilone D (KOS-862)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
45
June 2003
 

Inclusion Criteria:

  1. 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.
  2. Evidence of radiographically measurable or evaluable disease.

Exclusion Criteria:

  1. Pre-existing peripheral neuropathy of CTC Grade > 2 due to any cause.
  2. Documented hypersensitivity reaction (CTC Grade > 2) to prior paclitaxel or other therapy containing Cremophor.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00030173
 
KOS-101
Bristol-Myers Squibb
 
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP