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An Open-label, Single-arm Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Darbepoetin Alfa Administered Three Times Per Week for the Treatment of Anemia in Subjects With Non-myeloid Malignancies Receiving Multicycle Chemotherapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Myeloid Malignancies, Anemia, Cancer

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Trial Information

An Open-label, Single-arm Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Darbepoetin Alfa Administered Three Times Per Week for the Treatment of Anemia in Subjects With Non-myeloid Malignancies Receiving Multicycle Chemotherapy


Inclusion Criteria:



- Non-myeloid malignancy

- Currently receiving 3-week cyclic chemotherapy treatment with a minimum of 2
additional cycles of chemotherapy planned at the time of enrollment

- Anemia predominately due to cancer or chemotherapy (Hb >= 9.0 and < 11.0 g/dL) at the
time of screening

- 18 years of age or older at the time of screening

- Eastern Cooperative Oncology Group (ECOG) score 0-2

- Adequate liver and kidney function Exclusion Criteria:

- Known primary hematologic disorder, which could cause anemia, other than non-myeloid
malignancies

- History of chronic myeloid leukemia (CML), acute myeloid leukemia (AML),
myelodysplastic syndrome (MDS), acute lymphocytic leukemia (ALL), hairy cell
leukemia, Burkitt's lymphoma, or lymphoblastic lymphoma

- Serum folate <= 2.0 ng/mL or vitamin B12 <= 200 pg/mL at screening (anemia related to
nutritional deficiencies)

- Iron deficiency [transferrin saturation (TSAT) < 15% and serum ferritin < 10 ng/mL]
at screening

- Other diagnoses not related to cancer or chemotherapy, which cause anemia (ie,
hemolysis, bleeding, sickle cell anemia)

- Clinically significant inflammatory disease as determined by the investigator (eg,
rheumatoid arthritis, Crohn's disease)

- Clinically significant co-morbid medical or psychiatric conditions that may impact
subject safety or confound the ability to evaluate study endpoint as determined by
the investigator

- Unstable or uncontrolled cardiac disease or condition (ie, angina, congestive heart
failure, or cardiac arrhythmia)

- Diastolic blood pressure > 100 mmHg at screening

- Known hypersensitivity of erythropoietic-stimulating proteins (ESPs) or any
excipients

- Known history of pure red cell aplasia

- Known positive antibody response to an ESP

- Use of investigational agents not approved or any indication during the previous 30
days prior to enrollment

- ESP therapy (i.e., recombinant human erythropoietin [rHuEPO] or darbepoetin alfa)
within 21 days prior to screening or between screening and the first dose of study
drug

- RBC transfusion(s) within 21 days prior to screening

- Pregnant or breast-feeding women - Previously enrolled in this study

- Known to be HIV, hepatitis B or C positive

- Any disorder that would compromise the ability of the subject to give written
informed consent and comply with study requirements and procedures

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To characterize the PK of darbepoetin alfa administered at a SC dose of 0.45 mcg/kg TIW in the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy

Outcome Time Frame:

18 weeks

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20040232

NCT ID:

NCT00239239

Start Date:

August 2005

Completion Date:

March 2007

Related Keywords:

  • Non-Myeloid Malignancies
  • Anemia
  • Cancer
  • Non-myeloid malignancy
  • Chemotherapy-induced anemia
  • Oncology
  • Clinical Trials
  • Pharmacokinetics
  • Darbepoetin alfa
  • Aranesp
  • Amgen
  • Anemia
  • Neoplasms

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