TLK286 (Telcyta) in Combination With Cisplatin for Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

Phase 1

Completed

• Conditions: Non-small Cell Lung Cancer

• Registration Number: NCT00077883
• Lead Sponsor: Telik

Brief Summary

The purpose of this trial is to study the efficacy and safety of the combination of TLK286 with cisplatin as first-line therapy for patients with locally advanced or metastatic non-small cell lung cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2004-02-12
• Study First Submitted QC: 2004-02-13
• Study First Posted: 2004-02-16
• Status Verified: 2005-06
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Last Update Submitted: 2011-07-21
• Last Update Posted: 2011-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 18 years of age or older
• Histologically confirmed non-small cell lung cancer
• Stage IV or IIIB
• Measurable disease by RECIST
• ECOG performance status of 0-1
• Adequate liver and renal function
• Adequate bone marrow reserve

Exclusion Criteria

• History of bone marrow transplantation or stem cell support
• Pregnant or lactating women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Primary Objectives of the Study	Every 3 weeks	1. To determine the safety of TLK286 in combination with cisplatin in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC); 2. To determine the MTD of TLK286 in combination with cisplatin in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)

Trial Locations

Locations (3)

Univ. of MD, Greenbaum Cancer Center; 🇺🇸 Baltimore, Maryland, United States

The Sarah Cannon Cancer Center; 🇺🇸 Nashville, Tennessee, United States

Univ. of TX, MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States