NCT00035841

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2002

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 6, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2002

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
Last Updated

July 25, 2011

Status Verified

June 1, 2011

Enrollment Period

2.3 years

First QC Date

May 6, 2002

Last Update Submit

July 21, 2011

Conditions

Breast Neoplasms

Interventions

TLK286DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Indiana University Medical Center

Indianapolis, Indiana, 46202, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

TER 286

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 6, 2002

First Posted

May 7, 2002

Study Start

April 1, 2002

Primary Completion

July 1, 2004

Study Completion

July 1, 2004

Last Updated

July 25, 2011

Record last verified: 2011-06

Locations

US(3)