A Study of Darbepoetin Alfa in Anemic Subjects Not Receiving Chemotherapy Who Have Completed the 20010103 Study

Cancer Clinical Trial

Official title:

A Multicenter, Randomised, Double-Blind, Placebo-Controlled Roll Over Study to Protocol 20010103 of Darbepoetin Alfa for the Treatment of Anemia of Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00115167
• Other study ID #: 20020149
• Status: Completed
• Phase: Phase 3
• First received: June 21, 2005
• Last updated: May 7, 2009
• Start date: August 2004
• Est. completion date: March 2007

Study information

• Verified date: May 2009
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovakia: 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 AdministrationAustralia: Therapeutic Goods AdministrationAustria: Bundesamt für Sicherheit im GesundheitswesenBelgium: Service Public Federal Sante Publiquest, Securite de la Chaine 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 MedicinesLithuania: 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)Romania: Ministry of Health and the FamilyRussia: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety of darbepoetin alfa beyond 16 weeks of treatment in subjects with anemia of cancer who are not receiving chemotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 371
• Est. completion date: March 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects completing the planned 16 weeks of treatment on the 20010103 Anemia of Cancer protocol

Exclusion Criteria:

• Subjects currently receiving or planned to receive cytotoxic chemotherapy or myelosuppressive radiotherapy

• Subjects who have other diagnoses not related to the cancer which can cause anemia

• 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 enrollment

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

• Concerns for subject's compliance with the protocol procedures

Study Design

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

Related Conditions & MeSH terms

• Anemia
• Cancer

Intervention

Drug:
• Placebo
Q4W
• Darbepoetin alfa
Q4W

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		throughout study	Yes
Secondary	Confirmed antibody formation to investigational product		throughout study	Yes
Secondary	Deaths on study		on study	Yes
Secondary	Laboratory parameters		throughout study	Yes
Secondary	Vital signs (blood pressure)		throughout study	Yes
Secondary	Change in PRO scores		from baseline to end of treatment	No

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling