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Phase 2 Study of TLK286 in Metastatic Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Neoplasms

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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 CenterTucson, Arizona  85724
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Indiana University Medical CenterIndianapolis, Indiana  46202