Phase 2 Study of TLK286 in Metastatic Breast Cancer

Breast Neoplasms Clinical Trial

Official title:

Phase 2 Study of TLK286 in Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00035841
• Other study ID #: TLK286.2008
• Status: Completed
• Phase: Phase 2
• First received: May 6, 2002
• Last updated: July 21, 2011
• Start date: April 2002
• Est. completion date: July 2004

Study information

• Verified date: June 2011
• Source: Telik
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2004
• Est. primary completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• TLK286

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Indiana University Medical Center	Indianapolis	Indiana
United States	Arizona Cancer Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Telik

Country where clinical trial is conducted

United States,