NCT00030173

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2001

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 8, 2002

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
Last Updated

January 8, 2009

Status Verified

January 1, 2009

First QC Date

February 7, 2002

Last Update Submit

January 7, 2009

Conditions

Neoplasms

Keywords

Epothilone Dtubulin polymerization

Interventions

Epothilone D (KOS-862)DRUG

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Medical Center

Los Angeles, California, 90095-7059, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

desoxyepothilone B

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 7, 2002

First Posted

February 8, 2002

Study Start

October 1, 2001

Study Completion

June 1, 2003

Last Updated

January 8, 2009

Record last verified: 2009-01

Locations

US(1)