Phase I Study of Ixabepilone Administered as a 24-Hour Infusion in Patients With Advanced Solid Malignancies
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Solid Malignancies
Both
Solid Malignancies
Trial Information
Phase I Study of Ixabepilone Administered as a 24-Hour Infusion in Patients With Advanced Solid Malignancies
Inclusion Criteria:
- confirmed diagnosis of a primary solid tumor
- measurable or non-measurable disease
- progressive disease
- men and women greater or equal to 18 years of age.
Exclusion Criteria:
- women of child bearing potential who are not using birth control
- women who are pregnant or breast feeding
- women with a positive pregnancy test on enrollment
- patients with brain metastasis
- prior treatment with Ixabepilone
- known history of human immunodeficiency virus (HIV)
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Participants With Dose Limiting Toxicities at Dose Level
Outcome Time Frame:
Measures taken at Cycle 01 (21-day cycle)
Safety Issue:
Yes
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA163-085
NCT ID:
NCT00162136
Start Date:
September 2005
Completion Date:
July 2008
Related Keywords:
- Solid Malignancies
- Neoplasms
Name | Location |
|---|---|
| Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
| University of Maryland | Baltimore, Maryland 21201 |
| The Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
