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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 CenterNashville, Tennessee  37203
Univ. of TX, MD Anderson Cancer CenterHouston, Texas  77030
Univ. of MD, Greenbaum Cancer CenterBaltimore, Maryland  21201