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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Non-small Cell Lung Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Primary Objectives of the Study

Outcome Description:

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)

Outcome Time Frame:

Every 3 weeks

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

TLK286.2021

NCT ID:

NCT00077883

Start Date:

February 2004

Completion Date:

March 2007

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

The Sarah Cannon Cancer Center Nashville, Tennessee  37203
Univ. of TX, MD Anderson Cancer Center Houston, Texas  77030
Univ. of MD, Greenbaum Cancer Center Baltimore, Maryland  21201