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An Open-Label, Randomized Phase 2 Study to Validate a Patient Satisfaction Questionnaire for Anemia Treatment in Patients With Gynecological Malignancies Treated With Darbepoetin Alfa or Recombinant Human Erythropoietin for Anemia Due to Chemotherapy


Phase 2
18 Years
N/A
Not Enrolling
Female
Gynecological Malignancies, Genital Neoplasms, Female, Anemia

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Trial Information

An Open-Label, Randomized Phase 2 Study to Validate a Patient Satisfaction Questionnaire for Anemia Treatment in Patients With Gynecological Malignancies Treated With Darbepoetin Alfa or Recombinant Human Erythropoietin for Anemia Due to Chemotherapy


Inclusion Criteria:

- Subjects receiving multi-cycle chemotherapy for gynecological 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 - 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:

20020166

NCT ID:

NCT00121030

Start Date:

October 2002

Completion Date:

December 2003

Related Keywords:

  • Gynecological Malignancies
  • Genital Neoplasms, Female
  • Anemia
  • uterine cancer
  • ovarian cancer
  • darbepoetin alfa
  • Amgen
  • Gynecological Malignancies
  • Anemia
  • Neoplasms
  • Genital Neoplasms, Female

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