Phase 2 Study of TLK286 in Metastatic Breast Cancer

Phase 2

Completed

• Conditions: Breast Neoplasms

• Registration Number: NCT00035841
• Lead Sponsor: Telik

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Study First Submitted: 2002-05-06
• Study First Submitted QC: 2002-05-06
• Study First Posted: 2002-05-07
• Primary Completion: 2004-07
• Study Completion: 2004-07
• Status Verified: 2011-06
• Last Update Submitted: 2011-07-21
• Last Update Posted: 2011-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (3)

Indiana University Medical Center; 🇺🇸 Indianapolis, Indiana, United States

Cleveland Clinic Taussig Cancer Center; 🇺🇸 Cleveland, Ohio, United States

Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States