The Duration Study

• Status: Terminated
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the efficacy of epoetin alfa (PROCRIT®) administered subcutaneously (sc) once every week (qw) vs. no epoetin alfa (PROCRIT®) treatment in patients with cancer who are anemic.

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

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Ortho Biotech Products, L.P.
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Histologically confirmed diagnosis of non-myeloid malignancy

• Baseline hemoglobin value >= 11 g/dL and <= 12 g/dL unrelated to transfusion

• Female patients with reproductive potential must have a negative serum pregnancy test at screening. Patients must have signed an informed consent

Exclusion Criteria:

• Uncontrolled hypertension

• History (within 6 months) of uncontrolled cardiac arrhythmias, or history of pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic coagulation disorder

• Transfusion within 28 days prior to first dose

• Planned myelosuppressive chemotherapy or radiation during study and no prior chemotherapy within 8 weeks or radiation within 4 weeks of study entry.