Trial Information

A Randomized, Open-Label, Comparative Study of Epoetin Alfa (PROCRIT) 80,000 Units or 120,000 Units Q3W (Every 3 Weeks) Versus Darbepoetin Alfa (ARANESP) 500 Mcg Q3W in Anemic Cancer Subjects Receiving Chemotherapy

This is an open-label (both the physician and the patient know which treatment is being
provided), multi-center study of up to 16 weeks duration in which 450 patients will be
randomly assigned (patients are assigned to a specific study group by chance) to one of
three treatment groups in a 1:1:1 ratio. Patients will receive PROCRIT (epoetin alfa)
80,000 Units injected subcutaneously (under the skin) once every three weeks or 120,000
Units injected under the skin once every three weeks or ARANESP (darbepoetin alfa) 500 mcg
injected under the skin once every three weeks for up to 13 weeks. PROCRIT (epoetin alfa)
80,000 Units and 120,000 Units given once every three weeks are doses and schedules that are
not approved for use in the United States and are under investigation, while the ARANESP
dose and schedule are approved for use in the United States. Adult patients with specific
types of cancer (confirmed non-myeloid malignancy) who are scheduled to receive cyclic
chemotherapy for a minimum of 12 weeks during the study and who meet all other eligibility
criteria will be enrolled. This study will be conducted in approximately 80 study sites
located in the United States.

The study hypothesis is that a dosing regimen of PROCRIT (Epoetin alfa) 80,000 Units or
120,000 Units given once every three weeks is non-inferior to ARANESP 500 mcg given once
every three weeks with respect to the mean hemoglobin (Hb) change from baseline to Study
Week 7 in anemic cancer patients receiving chemotherapy. Hemoglobin levels will be monitored
throughout the study on a weekly basis and before each drug dose is administered. Drug
dosing will be adjusted (ie, held, reduced, resumed at a lower dose) as needed to maintain
hemoglobin values within desired ranges.

The maximum dose of PROCRIT (Epoetin alfa) allowed in this study is 120,000 Units every
three weeks (Q3W) and the maximum dose of ARANESP (darbepoetin) is 500 mcg Q3W.

Safety evaluations will be conducted throughout the study and will consist of assessment of
laboratory tests, vital signs, physical examinations. The occurrence and severity of adverse
events, including thrombovascular events will be evaluated throughout the study.Periodic
data monitoring of the study by an external Independent Data Monitoring Committee (IDMC)
will be performed. The main responsibility of the IDMC is to conduct ongoing monitoring of
safety and to report any irregularities back to the Sponsor along with recommendations
regarding continuation of the study. Each patient will be assigned to one of three dosing
schedules. All schedules will be administered by way of subcutaneous (under the skin)
injection once every three weeks over a period of 13 weeks. The three dosing schedules are
as follows: PROCRIT (epoetin alfa) 80,000 Units, PROCRIT (epoetin alfa) 120,000 Units or
ARANESP (darbepoetin alfa) 500 mcg