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

Overview

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.

Full Title of Study: “Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Cisplatin as First-Line Therapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2007

Interventions

  • Drug: TLK286, cisplatin
    • TLK286 administered once every 3 weeks (± 2 days) at two dose-ranging levels (750 mg/m²) and 1,000 mg/²) in combination with two dose levels of cisplatin (75 mg/m² and 100 mg/m²) of cisplatin once every 3 weeks (± 2 days).

Clinical Trial Outcome Measures

Primary Measures

  • Primary Objectives of the Study
    • Time Frame: Every 3 weeks
    • To determine the safety of TLK286 in combination with cisplatin in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) To determine the MTD of TLK286 in combination with cisplatin in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Telik
  • Provider of Information About this Clinical Study
    • Gail Brown, MD Chief Medical Officer, Telik, Inc.

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