Phase 2 Study of TLK286 in Metastatic Breast Cancer
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Breast Neoplasms
Both
Breast Neoplasms
Trial Information
Phase 2 Study of TLK286 in Metastatic Breast Cancer
Inclusion Criteria:
- Histologic diagnosis of breast cancer
- Metastatic disease
- Measurable or evaluable disease
- No prior chemotherapy regimens
- Age at least 18 years
- Adequate liver and kidney function
- Adequate bone marrow function
Exclusion Criteria:
- Pregnant or lactating women
- Unstable medical conditions
- Chemotherapy within 14 days of TLK286
- Radiation therapy within 14 days of TLK286
- Hormonal therapy within 14 days of TLK286
- Immunotherapy within 14 days of TLK286
- CNS metastasis unless controlled by treatment
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
Authority:
United States: Food and Drug Administration
Study ID:
TLK286.2008
NCT ID:
NCT00035841
Start Date:
April 2002
Completion Date:
July 2004
Related Keywords:
- Breast Neoplasms
- Breast Neoplasms
- Neoplasms
Name | Location |
|---|---|
| Arizona Cancer Center | Tucson, Arizona 85724 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| Indiana University Medical Center | Indianapolis, Indiana 46202 |
