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A Phase 1, Dose Escalation Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Epothilone D in Patients With Advanced Solid Tumors


Phase 1
18 Years
85 Years
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

A Phase 1, Dose Escalation Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Epothilone D in Patients With Advanced Solid Tumors


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

KOS-101

NCT ID:

NCT00030173

Start Date:

October 2001

Completion Date:

June 2003

Related Keywords:

  • Neoplasms
  • Epothilone D
  • tubulin polymerization
  • Neoplasms

Name

Location

UCLA Medical CenterLos Angeles, California  90095-7059