TLK286 in Breast Neoplasms - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Breast Neoplasms

Intervention / Treatment

Drug: TLK286

Study Type

Interventional

Enrollment

60

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Arizona
  - Tucson, Arizona, United States, 85724
    - Arizona Cancer Center
- Indiana
  - Indianapolis, Indiana, United States, 46202
    - Indiana University Medical Center
- Ohio
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic Taussig Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Telik

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

July 1, 2004

Study Completion (Actual)

July 1, 2004

Study Registration Dates

First Submitted

May 6, 2002

First Submitted That Met QC Criteria