A Dose Finding Study of KRN321(Darbepoetin Alfa) for the Treatment of Anemia in Subjects With Solid Tumor
Information source: Kirin Pharma Company, Limited
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anemia
Intervention: darbepoetin alfa (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Kirin Pharma Company, Limited Official(s) and/or principal investigator(s):
Nagahiro Saijo, MD, Study Chair, Affiliation: National Cancer Center Hospital East
Summary
To assess the clinical effective dose of KRN321 administered with once triweekly schedule.
Clinical Details
Official title: A Randomized, Dose - Finding Study of KRN321(Darbepoetin Alfa) for the Treatment of Anemia in Subjects With Solid Tumor
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To compare the effectiveness of KRN321(darbepoetin alfa) on the proportion of subjects achieving hemoglobin response
Secondary outcome: To compare the proportion of subjects who receive red blood cell transfusions or show the hemoglobin level below 8 g/dLTo compare the proportion of subjects who receive red blood cell transfusions To compare the effectiveness of KRN321 based on quality of life scores
Eligibility
Minimum age: 20 Years.
Maximum age: 74 Years.
Gender(s): Both.
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
Locations and Contacts
Hokkaido region, Hokkaido, Japan
Tohoku region, Miyagi, Japan
Kanto region, Tochigi, Saitama, Tokyo, Kanagawa, Japan
Hokuriku region, Niigata, Ishikawa, Japan
Tokai region, Aichi, Japan
Kinki region, Kyoto, Osaka, Nara, Japan
Shikoku region, Ehime, Japan
Kyusyu region, Fukuoka, Kumamoto, Japan
Additional Information
Starting date: July 2006
Ending date: March 2008
Last updated: April 18, 2008
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