Fractionated Dosing Study: Study to Evaluate Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies

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

The purpose of this study is to characterize the pharmacokinetics/pharmacodynamics (PK/PD) of darbepoetin alfa administered at a subcutaneous (SC) dose of 0.45 mcg/kg three times weekly (TIW) in anemic patients with non-myeloid malignancies receiving multicycle chemotherapy.

Study Overview

• Status: Completed
• Conditions: Cancer; Anemia; Non-Myeloid Malignancies
• Intervention / Treatment: Drug: Darbepoetin alfa

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: test treatment period	Drug: Darbepoetin alfa; darbepoetin alfa SC dosing 0.45 mcg/kg 3 times per week through study day 40. Optional extended treatment period: 200 mcg Q2W through study day 110

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	18 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess the effect of darbepoetin alfa treatment on hematopoietic response, red blood cell (RBC) transfusion requirements, and the safety of darbepoetin alfa in subjects receiving multicycle chemotherapy	18 weeks

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start: August 1, 2005
• Primary Completion (Actual): January 1, 2007
• Study Completion (Actual): March 1, 2007

Study Registration Dates

• First Submitted: October 13, 2005
• First Submitted That Met QC Criteria: October 13, 2005
• First Posted (Estimate): October 17, 2005

Study Record Updates

• Last Update Posted (Estimate): March 5, 2010
• Last Update Submitted That Met QC Criteria: March 4, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Darbepoetin alfa; Oncology; Non-myeloid malignancy; Chemotherapy-induced anemia; Clinical Trials; Aranesp; Amgen
• Additional Relevant MeSH Terms: Hematologic Diseases; Neoplasms; Anemia; Hematinics; Darbepoetin alfa
• Other Study ID Numbers: 20040232

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No