Brief Summary

The purpose of this trial is to study the efficacy and safety of the triplet combination of TLK286, carboplatin and paclitaxel as first-line therapy for patients with advanced non-small cell lung cancer.

Trial Health

On Track

Trial Health Score

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

Enrollment

100

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Aug 2004

Longer than P75 for phase_1

Geographic Reach

1 country

52 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

4.8 years study duration

First Submitted

Initial submission to the registry

July 29, 2004

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 30, 2004

Completed

2 days until next milestone

Study Start

First participant enrolled

August 1, 2004

Completed

4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed

Last Updated

May 31, 2012

Status Verified

June 1, 2011

Enrollment Period

4.8 years

First QC Date

July 29, 2004

Last Update Submit

May 30, 2012

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

Study Objectives
1. To determine the MTD of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin 2. To determine the safety of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin 3. To determine the objective response rate (ORR) of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin
Every 6 Weeks

Study Arms (1)

Triplet Combination of TLK286 Carboplatin & Paclitaxel

EXPERIMENTAL

Experimental

Drug: TLK286Drug: carboplatinDrug: paclitaxel

Interventions

TLK286DRUG

Every 3 Weeks with a starting dose of TLK286 @ 400 mg/m²

Triplet Combination of TLK286 Carboplatin & Paclitaxel

carboplatinDRUG

AUC 6 mg/mL/min Once every 3 weeks

Triplet Combination of TLK286 Carboplatin & Paclitaxel

paclitaxelDRUG

200 mg/m² Once every 3 weeks

Triplet Combination of TLK286 Carboplatin & Paclitaxel

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

years of age or older
Histologically confirmed non-small cell lung cancer (NSCLC)
Stage IV or IIIB (disease that is not eligible for combined modality chemotherapy and radiation)
Measurable disease by RECIST
ECOG status of 0-1
Adequate liver and renal function
Adequate bone marrow reserves

You may not qualify if:

Prior chemotherapy, immunotherapy or biologic therapy for metastatic NSCLC
Up to one prior adjuvant or neoadjuvant chemotherapy is allowed
History of bone marrow transplantation or stem cell support
Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Teliklead

Study Sites (52)

Bay Area Cancer Research Group

Concord, California, 94520, United States

Location

East Bay Medical Oncology/Hematology Associates

Concord, California, 94520, United States

Location

Southwest Cancer Care

Escondido, California, 92025, United States

Location