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An Open-Label, Randomized Phase 2 Study to Validate a Patient Satisfaction Questionnaire for Anemia Treatment in Patient With Non-Small Cell Lung Cancer Treated With Darbepoetin Alfa or Recombinant Human Erythropoietin for Anemia Due to Chemotherapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer, Anemia

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Trial Information

An Open-Label, Randomized Phase 2 Study to Validate a Patient Satisfaction Questionnaire for Anemia Treatment in Patient With Non-Small Cell Lung Cancer Treated With Darbepoetin Alfa or Recombinant Human Erythropoietin for Anemia Due to Chemotherapy


Inclusion Criteria:

- Subjects receiving multi-cycle chemotherapy for non-small cell lung
cancer - Anemia due to chemotherapy (hgb less than or equal to 11.0 g/dL) - Expected to
receive greater than or equal to 8 additional weeks of chemotherapy as part of their
planned treatment - Karnofsky Performance Scale (KPS) greater than or equal to 50% -
Adequate renal function - Adequate liver function Exclusion Criteria: - Iron deficiency -
Unstable cardiac disease - Known positive test for human immunodeficiency virus (HIV)
infection

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Anemia correction

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Institutional Review Board

Study ID:

20020165

NCT ID:

NCT00120679

Start Date:

October 2002

Completion Date:

December 2003

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Anemia
  • non-small cell lung cancer
  • darbepoetin alfa
  • Amgen
  • Anemia
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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