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

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Darbepoetin alfa

Criteria

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