IRON CLAD: Can Iron Lessen Anemia Due to cancer and chemotherapy: A multicenter, randomized, double-blinded, controlled study to investigate the efficacy and safety of Injectafer® (ferric carboxymaltose injection) in adults

uitpold Pharmaceuticals, Inc.0 个研究点目标入组 222 人开始时间: 2016年8月12日最近更新: 2018年4月30日

适应症

试验速览

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•1. Subjects (male or female) = 18 years of age able to give informed consent to the study
•[removed] 2. Subjects whose cancer treatment is considered non-curative
•2. Subjects with solid tumors that have metastasized
•3. Receiving chemotherapy as part of their cancer treatment, with at least 4 weeks of treatment remaining
•4. Screening visit central laboratory Hgb <11 g/dL, but =8 g/dL
•5. Ferritin between 100 and 800 ng/mL and transferrin saturation (TSAT) = 25%
•6. Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
•7. Life expectancy of at least 6 months
•8. Demonstrate the ability to understand the requirements of the study, willingness to abide by study restrictions and to return for the required assessments.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 194
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 28

•1. Previous participation in a FCM clinical trial
•2. Known hypersensitivity reaction to any component of FCM
•3. Any anemia treatment within 4 weeks before inclusion (oral iron, IV iron, RBC transfusion, or ESAs)
•4. Patients on ESAs
•5. Requiring dialysis for the treatment of CKD
•6. Any non-viral infection
•7. Patients with overt bleeding
•8. Known positive hepatitis with evidence of active disease
•9. Received an investigational drug within 30 days of screening
•10. Alcohol or drug abuse within the past 6 months
•11. Hemochromatosis or other iron storage disorders
•12. Any other laboratory abnormality, medical condition or psychiatric disorders which in the opinion of the Investigator would put the subject’s disease management at risk or may result in the subject being unable to comply with study requirements.
•13. Pregnant or actively trying to become pregnant (Female subjects who are of childbearing age must have a negative pregnancy test at screening and be practicing an acceptable method of birth control during the study.).

发起方

uitpold Pharmaceuticals, Inc.