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

Amgen

Status and phase: Completed; Phase 3

Conditions: Anemia; Cancer

Treatments: Drug: Darbepoetin alfa; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00115167

20020149

Details and patient eligibility

About

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.

Enrollment: 371 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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371 participants in 2 patient groups, including a placebo group

Darbepoetin alfa

Experimental group

Treatment:

Drug: Darbepoetin alfa

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo