NCT00040638

Brief Summary

The purpose of this study is to determine the effectiveness of TLK286 in the treatment of advanced non-small cell lung cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2002

Shorter than P25 for phase_2

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

July 1, 2002

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 4, 2002

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
Last Updated

July 25, 2011

Status Verified

June 1, 2011

Enrollment Period

1.1 years

First QC Date

July 2, 2002

Last Update Submit

July 21, 2011

Conditions

Carcinoma, Non-small-cell Lung

Interventions

TLK286DRUG

Eligibility Criteria

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

You may qualify if:

  • Histologic or cytologic diagnosis of non-small cell lung carcinoma
  • Progressed while on or after treatment on platinum-based regimen
  • Patients may not have had more than one prior cytotoxic chemotherapy regimen
  • Stage IV or IIIB
  • Age at least 18 years
  • Adequate liver and kidney function
  • Adequate bone marrow function

You may not qualify if:

  • Pregnancy or lactation
  • Unstable medical conditions
  • Chemotherapy, hormonal therapy, radiotherapy, radiopharmaceuticals or immunotherapy within 3 weeks 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

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

TER 286

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract 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

July 2, 2002

First Posted

July 4, 2002

Study Start

July 1, 2002

Primary Completion

August 1, 2003

Study Completion

August 1, 2003

Last Updated

July 25, 2011

Record last verified: 2011-06

Locations

US(3)