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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00030173
Recruitment Status : Completed
First Posted : February 8, 2002
Last Update Posted : January 8, 2009
Sponsor:
Information provided by:
Bristol-Myers Squibb

Brief Summary:
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 or disease Intervention/treatment Phase
Neoplasms Drug: Epothilone D (KOS-862) Phase 1

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Study Type : Interventional  (Clinical Trial)
Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2001
Actual Study Completion Date : June 2003




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00030173


Locations
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United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095-7059
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

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ClinicalTrials.gov Identifier: NCT00030173    
Obsolete Identifiers: NCT00033501
Other Study ID Numbers: KOS-101
First Posted: February 8, 2002    Key Record Dates
Last Update Posted: January 8, 2009
Last Verified: January 2009
Keywords provided by Bristol-Myers Squibb:
Epothilone D
tubulin polymerization
Additional relevant MeSH terms:
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Epothilones
Desoxyepothilone B
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents