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A Randomized, Open-Label, Pilot Study to Evaluate Every Three Week Maintenance Dosing of Darbepoetin Alfa Therapy in Anemic Subjects With Non-Myeloid Malignancies Receiving Chemotherapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Neoplasms, Anemia

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Trial Information

A Randomized, Open-Label, Pilot Study to Evaluate Every Three Week Maintenance Dosing of Darbepoetin Alfa Therapy in Anemic Subjects With Non-Myeloid Malignancies Receiving Chemotherapy


Inclusion Criteria:

- Subjects with non-myeloid malignancies - Anemia (screening
hemoglobin concentration greater than or equal to 10.5 g/dL but less than or equal to 12.0
g/dL) related to cancer and chemotherapy - At least 8 additional weeks of cyclic
chemotherapy planned regardless of schedule - Karnofsky Performance Status of greater than
or equal to 50% - Serum creatinine concentration less than or equal to 2.0 mg/dL Exclusion
Criteria: - Iron deficiency - Red blood cell (RBC) transfusion within 4 weeks of screening
- Unstable cardiac disease

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To assess the ability of darbepoetin alfa to maintain hemoglobin concentrations greater than or equal to 10 g/dL when administered every 3 weeks (Q3W)

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Institutional Review Board

Study ID:

20020167

NCT ID:

NCT00120705

Start Date:

November 2002

Completion Date:

September 2003

Related Keywords:

  • Neoplasms
  • Anemia
  • anemia
  • darbepoetin alfa
  • Amgen
  • Non-myeloid Malignancies
  • Anemia
  • Neoplasms

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