Study of Darbepoetin Alfa for the Treatment of Anemia of Cancer

Cancer Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Darbepoetin Alfa for the Treatment of Anemia of Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00091858
• Other study ID #: 20010103
• Status: Completed
• Phase: Phase 3
• First received: September 17, 2004
• Last updated: May 6, 2013
• Start date: April 2004
• Est. completion date: December 2006

Study information

• Verified date: May 2013
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Therapeutic Goods AdministrationAustria: Bundesamt für Sicherheit im GesundheitswesenBelgium: Service Public Fédéral Santé Publique, Sécurité de la Chaîne alimentaire et EnvironnementCanada: Health CanadaCzech Republic: Statni ustav pro kontrolu lecivEstonia: State Agency of MedicinesHungary: National Institute of PharmacyItaly: Ministry of HealthLatvia: State Agency of MedicinesRomania: Ministry of Health and the FamilyRussia: Ministry of HealthSlovakia: Štátny ústav pre kontrolu liecivSpain: Agencia Española de Medicamentos y Productos SanitariosSwitzerland: Agency for Therapeutic ProductsUkraine: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug AdministrationLithuania: State Medicines Control Agency of LithuaniaNetherlands: Medicines Evaluation BoardNetherlands: Medisch Centrum Rijnmond_Zuid, lcatie ZuiderPoland: Drug InstitutPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPortugal: Instituto Nacional da Farmácia e do Medicamento (INFARMED)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of darbepoetin alfa versus placebo in reducing the occurrences of red blood cell transfusions in subjects with anemia of cancer who are not receiving chemotherapy.

Other known NCT identifiers

• NCT00098696

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: December 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• subjects with non-myeloid malignancies

• anemia due to cancer

• ECOG status 0 to 2

• greater than or equal to 4-month expectancy

• greater than or equal to 18 years and of legal age for informed consent

• screening hemoglobin concentration less than or equal to 11.0g/dL

• adequate serum folate and vitamin B12

• adequate renal and liver function

• written informed consent

Exclusion Criteria:

• subjects currently receiving or planned to receive cytotoxic chemotherapy or myelosuppressive radiotherapy during the study or within 4 weeks before randomization

• in complete remission, as determined by the investigator

• subjects who have other diagnoses not related to the cancer which cause anemia (eg. gastrointestinal bleeding, renal disease, etc)

• documented history of pure red cell aplasia

• Known history of seizure disorder

• cardiac condition: uncontrolled angina, congestive heart failure, known ejection fraction less than 40%, or uncontrolled cardiac arrhythmia

• uncontrolled hypertension

• clinically significant systemic infection or chronic inflammatory disease present at the time of randomization

• iron deficiency

• known positive test for HIV infection

• previously suspected of or confirmed to have neutralizing antibodies to rHuEPO or darbepoetin alfa

• received rHuEPO or darbepoetin alfa therapy within 4 weeks of randomization

• 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

• subject of reproductive potential who is not using adequate contraceptive precautions

• known hypersensitivity to mammalian-derived product or any other ingredients in the investigational product

• previously randomized into this study

• concerns for subject's compliance with the protocol procedures

Study Design

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

Related Conditions & MeSH terms

• Anemia
• Cancer

Intervention

Drug:
• Darbepoetin Alfa
6.75 mcg/kg Q4W
• Placebo
Placebo Q4W

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (1)

Smith RE Jr, Aapro MS, Ludwig H, Pintér T, Smakal M, Ciuleanu TE, Chen L, Lillie T, Glaspy JA. Darbepoetin alpha for the treatment of anemia in patients with active cancer not receiving chemotherapy or radiotherapy: results of a phase III, multicenter, ra — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrences of red blood cell transfusion		from study day 29 (week 5) to week 17	No
Secondary	Incidence of first red blood cell transfusion		from week 5 (study day 29) to week 17 (study day 119)	No
Secondary	Change in hemoglobin concentration measured		from baseline (study day 1) to EOTP	No
Secondary	Adverse events and serious adverse events		throughout study for subjects who received at least 1 dose of investigational product	Yes
Secondary	Survival		deaths on study and deaths in long-term follow-up period for subjects who received at least 1 dose of investigational product	Yes
Secondary	Incidence, if any, of neutralizing antibody formation to investigational product		throughout study for subjects who received at least 1 dose of investigational product	Yes

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling