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

NCT00239239 | Completed Phase 2

• 1 other identifier: 20040232
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Non-Myeloid Malignancies; Anemia; Cancer

Keywords

Non-myeloid malignancy; Chemotherapy-induced anemia; Oncology; Clinical Trials; Pharmacokinetics; Darbepoetin alfa; Aranesp; Amgen

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

test treatment period

EXPERIMENTAL

Drug: Darbepoetin alfa

Interventions

Darbepoetin alfa DRUG

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

test treatment period

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older at the time of screening
• Eastern Cooperative Oncology Group (ECOG) score 0-2

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Anemia; Neoplasms

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 13, 2005
• First Posted: October 17, 2005
• Study Start: August 1, 2005
• Primary Completion: January 1, 2007
• Study Completion: March 1, 2007
• Last Updated: March 5, 2010

Record last verified: 2010-03