NCT00047801

Brief Summary

The purpose of this study is to determine the effectiveness and safety of TLK286 given intravenously once every three weeks in combination with docetaxel (Taxotere) in the treatment of patients with non-small cell lung cancer that is resistant to platinum-based chemotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2002

Geographic Reach
1 country

4 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

October 1, 2002

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 21, 2002

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
Last Updated

July 25, 2011

Status Verified

June 1, 2011

Enrollment Period

1.9 years

First QC Date

October 18, 2002

Last Update Submit

July 21, 2011

Conditions

Carcinoma, Non-small-cell Lung

Interventions

TLK286 in combination with docetaxelDRUG

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed non-small cell bronchogenic carcinoma, including squamous cell carcinoma, undifferentiated carcinoma, adenocarcinoma, mixed (adenocarcinoma with squamous cell carcinoma), bronchoalveolar carcinoma, or large cell carcinoma
  • Stage IV or Stage IIIB
  • Progressed during or after first-line therapies with platinum-containing regimens in the advanced or metastatic treatment regimen
  • At least 18 years of age
  • Good performance status (ECOG 0 to 1)
  • Adequate liver, renal, and bone marrow function

You may not qualify if:

  • Pregnant or lactating women
  • Treatment with more than one cytotoxic therapy
  • Prior radiation to the whole pelvis
  • Unstable medical conditions such as uncontrolled cardiac arrhythmia
  • Patients with known history of severe hypersensitivity reactions to docetaxel or other drugs formulated with polysorbate 80

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Cancer Institute Medical Group

Los Angeles, California, 90025, United States

Location

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

TER 286Docetaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 18, 2002

First Posted

October 21, 2002

Study Start

October 1, 2002

Primary Completion

September 1, 2004

Study Completion

September 1, 2004

Last Updated

July 25, 2011

Record last verified: 2011-06

Locations

US(4)