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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT00030173
Collaborator
(none)
45
Enrollment
1
Location
20
Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Epothilone D (KOS-862)
 Phase 1

Study Design

Study Type:
Interventional
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 :
Oct 1, 2001
Actual Study Completion Date :
Jun 1, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCLA Medical Center Los Angeles California United States 90095-7059

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00030173
    Other Study ID Numbers:
    • KOS-101
    • NCT00033501
    First Posted:
    Feb 8, 2002
    Last Update Posted:
    Jan 8, 2009
    Last Verified:
    Jan 1, 2009
    Keywords provided by , ,
    Epothilone D
    tubulin polymerization
    Additional relevant MeSH terms:
    Epothilones
    Desoxyepothilone B

    Study Results

    No Results Posted as of Jan 8, 2009