Phase 2 Study of TLK286 in Metastatic Breast Cancer

Telik

Status and phase: Completed; Phase 2

Conditions: Breast Neoplasms

Treatments: Drug: TLK286

Study type: Interventional

Funder types: Industry

Identifiers

NCT00035841

TLK286.2008

Details and patient eligibility

About

The purpose of this study is to determine the effectiveness of TLK286 in treatment of metastatic breast cancer.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)