A Dose Finding Study of KRN321(Darbepoetin Alfa) for the Treatment of Anemia in Subjects With Solid Tumor

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To assess the clinical effective dose of KRN321 administered with once triweekly schedule.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Hakko Kirin Company, Limited; Kyowa Kirin Co., Ltd.
• Treatments: Darbepoetin alfa

Criteria

Inclusion Criteria:

• patients diagnosed as solid tumor or malignant lymphoma

• patients receiving cyclic chemotherapy

• written informed consent

• hemoglobin concentration below 11 d/dL at enrollment

• life expectancy of more than 4 months

Exclusion Criteria:

• hemolysis, gastrointestinal bleeding, postoperative bleeding

• iron deficiency

• megaloblastic anemia

• received > 2 RBC transfusions within 4 weeks before randomization or any RBC transfusion within 2 weeks before randomization

• any primary hematological disorder that could cause anemia

• prior treatment with KRN321

• received erythropoetin therapy within 8 weeks before treatment