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

Kyowa Kirin

Status and phase: Completed; Phase 2

Conditions: Anemia

Treatments: Drug: darbepoetin alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT00359840

KRN321-SC/05-A55

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind