A Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy

Anemia Clinical Trial

Official title:

A Randomized, Double Blind, Active-Controlled Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00118638
• Other study ID #: 20030231
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2005
• Last updated: April 25, 2013
• Start date: March 2004
• Est. completion date: January 2005

Study information

• Verified date: April 2013
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und ImpfstoffeHungary: National Institute of PharmacyItaly: Local Ethics CommitteesLatvia: State Agency of MedicinesLithuania: State Medicines Control Agency of LithuaniaNetherlands: Medisch Centrum Rijnmond_Zuid, lcatie ZuiderNorway: Norwegian Medicines AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPortugal: Instituto Nacional da Farmácia e do Medicamento (INFARMED)Romania: Ministry of Health and the FamilySlovakia: Štátny ústav pre kontrolu liecivSpain: Agencia Española de Medicamentos y Productos SanitariosSweden: Medical Products AgencySwitzerland: Agency for Therapeutic ProductsUkraine: Ministry of HealthAustria: Bundesamt für Sicherheit im GesundheitswesenBelgium: Service Public Federal Sante Publiquest, Securite de la Chaine alimentaire et EnvironnementBulgaria: Ministry of HealthCzech Republic: Statni ustav pro kontrolu lecivDenmark: LaegemiddelstyrelsenEstonia: State Agency of MedicinesFinland: LääkelaitosUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of darbepoetin alfa as 500ug once every 3 weeks to show that the dose and schedule are not inferior to darbepoetin alfa administered as 2.25ug/kg once per week in the treatment of anemia in subjects with non-myeloid malignancies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 705
• Est. completion date: January 2005
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Non-myeloid malignancy

• At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule

• Eastern Cooperative Oncology Group performance status of 0-2

• Hemoglobin concentration of less than 11 g/dL within 24 hours before randomization

• Of legal age at the time written informed consent is obtained

Exclusion Criteria:

• Known history of seizure disorder

• Known primary hematologic disorder, which could cause anemia, other than a non-myeloid malignancy

• Unstable or uncontrolled disease/condition, related to or affecting cardiac function

• Clinically significant inflammatory disease

• Inadequate renal and/or liver function

• Known positive HIV test

• Previously suspected of or confirmed to have neutralizing antibodies to rHuEPO

• Received more than 2 red blood cell (RBC) transfusions within 4 weeks before randomization or any RBC transfusion within 14 days before randomization, or any planned RBC transfusion between randomization and study day 1

• Received any erythropoietic therapy within 4 weeks before randomization or any planned erythropoietic therapy between randomization and study day 1

• Other investigational procedures

• Subject is currently enrolled in or less than 30 days since receipt of any investigational drug or device that is not approved by the applicable regulatory authority

• Pregnant or breast feeding

• Not using adequate contraceptive precautions

• Known sensitivity to any of the products to be administered during dosing

• Previously randomized in this study

• Concerns for subject's compliance with protocol procedures

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Neoplasms
• Non-Myeloid Malignancies

Intervention

Drug:
• Darbepoetin alfa - 2.25 mcg/kg
Darbepoetin alfa 2.25 mcg/kg QW dosing/ placebo Q3W
• Darbepoetin alfa - 500mcg
Darbepoetin alfa 500mcg Q3W dosing / placebo QW

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (3)

Canon JL, Vansteenkiste J, Bodoky G, Mateos MV, Bastit L, Ferreira I, Rossi G, Amado RG. Randomized, double-blind, active-controlled trial of every-3-week darbepoetin alfa for the treatment of chemotherapy-induced anemia. J Natl Cancer Inst. 2006 Feb 15;9 — View Citation

Canon JL, Vansteenkiste J, Hedenus M, Gascon P, Bokemeyer C, Ludwig H, Vermorken J, Legg J, Pujol B, Bridges K. Transfusion risk in cancer patients with chemotherapy-induced anemia when initiating darbepoetin alfa therapy at a baseline hemoglobin level of <9 g/dL versus 9 to <10 g/dL versus = 10 g/dL: an exploratory analysis of a phase 3 trial. Med Oncol. 2012 Sep;29(3):2291-9. doi: 10.1007/s12032-011-0103-x. Epub 2011 Nov 13. — View Citation

Vansteenkiste J, Hedenus M, Gascon P, Bokemeyer C, Ludwig H, Vermorken J, Hamilton L, Bridges K, Pujol B. Darbepoetin alfa for treating chemotherapy-induced anemia in patients with a baseline hemoglobin level < 10 g/dL versus > or = 10 g/dL: an explorator — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of at least one RBC transfusion from week 5 to End of Treatment Period (EOTP)		from week 5 to EOTP	No
Secondary	Incidence of achieving a hemoglobin concentration of greater than or equal to 11.0 g/dL, in the absence of RBC transfusions in the preceding 28 days, from week 5 to EOTP		from week 5 to EOTP	No
Secondary	Incidence of at least one RBC transfusion from week 1 (day 1) to EOTP		from week 1 (day 1) to EOTP	No
Secondary	Incidence of achieving a hemoglobin concentration greater than or equal to 11.0 g/dL, in the absence of RBC transfusions in the preceding 28 days, from week 1 to EOTP		from week 1 to EOTP	No
Secondary	Change in FACT-G Physical Well-being subscale from baseline to EOTP		from baseline to EOTP	No
Secondary	Change in hemoglobin from baseline to EOTP		from baseline to EOTP	No
Secondary	Change in FACT-Fatigue subscale score from baseline to EOTP		from baseline to EOTP	No
Secondary	Change in FACT-G total score from baseline to EOTP		from baseline to EOTP	No
Secondary	Change in EQ-5D Thermometer from baseline to EOTP		from baseline to EOTP	No
Secondary	Change in BSI Anxiety scale score from baseline to EOTP		from baseline to EOTP	No
Secondary	Change in BSI Depression scale score from baseline to EOTP		from baseline to EOTP	No
Secondary	Incidence and severity of adverse events		throughout study	Yes
Secondary	Incidence of hemoglobin concentration greater than 13.0 g/dL at any time on study		at any time on study	Yes
Secondary	Change in number of caregiver hours from baseline to EOTP		from baseline to EOTP	No
Secondary	Incidence of an increase in hemoglobin concentration greater than or equal to 2 g/dL in a 28-day window and any negative clinical consequences		throughout study	Yes
Secondary	Incidence of an increase in hemoglobin concentration of greater than or equal to 1 g/dL in a 14-day window and any negative clinical consequences		throughout study	Yes
Secondary	Incidence of a confirmed antibody formation to darbepoetin alfa		throughout study	Yes

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling