Chemotherapy-induced anemia (CIA) MedDRA version: 9.1 Level: LLT Classification code 10064469 Term: Anemia post chemotherapy
Conditions
Interventions
Product Name: Darbepoetin Alfa
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Darbepoetin alfa
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentrati
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Disease Related • Diagnosed with Ewing’s sarcoma, neuroblastoma, osteosarcoma, soft tissue sarcoma or medulloblastoma • Currently receiving non-myeloablative chemotherapy treatment and expecting to receive at least a further 9 weeks of chemotherapy Demographic • Male or female age 1 to 18 years of age at randomisation • ECOG performance status of 0, 1, or 2 assessed by the investigator at screening Laboratory • Screening hemoglobin level = 10.0 g/dL. (If screening takes more than 7 days, confirmation hemoglobin must be performed within 7 days before randomisation.) Ethical • A legal guardian willing and able to provide written informed consent and subject is willing and able to provide written assent, when required. Written informed consent and subject assent, when required, must be obtained from the legally accepted representative before any study-specific procedures are performed Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Disease Related • Anemia related to nutritional deficiencies per investigator judgement • Planned myeloablative radiation therapy during the screening or treatment periods • Planned myeloablative therapy (eg bone marrow transplant) within 3 weeks following the last dose of investigational product • Diagnosis of conditions not related to chemotherapy which cause anemia (eg, gastrointestinal bleeding, renal disease) • Unstable cardiac condition per investigator judgement • Uncontrolled hypertension per investigator judgement • Documented history of pure red cell aplasia • History of clinically significant venous thromboembolic event (VTE) within 6 months of screening (clinically significant VTE does not include superficial thrombosis) Laboratory • Received any RBC transfusion within 21 days before randomisation • Plan to receive any RBC transfusion between randomisation and study day 1 • Inadequate renal and/or liver function: creatinine > 2X ULN and/or transaminases > 5X ULN (>10 X ULN if the subject is receiving methotrexate treatment) • Known positive test of human immunodeficiency virus (HIV) • Transferrin saturation < 15% and ferritin < 22.5 pmol/L (< 10 ng/mL) at screening. Medications • Previous use of investigational agent(s) or devices not approved for any indication during the 30 days prior to the first screening visit • Known previous treatment failure to erythropoiesis stimulating agent (ESA) (ie, rHuEpo, darbepoetin alfa) • ESA therapy at any time during the 28 days prior to screening General • Subjects of reproductive potential who are pregnant, breast feeding or not using effective contraceptive precautions in the judgement of the investigator (including females of childbearing potential who are partners of male subjects) • Previously randomised to this trial • Known hypersensitivity to recombinant ESAs or the excipients contained within the investigational product • Confirmed history of neutralizing antibody activity to rHuEpo or darbepoetin alfa • Any condition that compromises the ability of the subject or legal representative to give written informed consent and/or comply with study instructions and procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of darbepoetin alfa with respect to the change in hemoglobin level, compared with placebo, when administered once every three weeks (Q3W) at doses of 4.5 µg/kg and 6.75 µg/kg to paediatric subjects with a diagnosis of Ewing’s sarcoma, neuroblastoma, osteosarcoma, soft tissue sarcoma or medulloblastoma;Secondary Objective: To evaluate the incidence of Red Blood Cell (RBC) transfusion To summarize the volume of RBC transfused To evaluate categorical changes in hemoglobin level compared to baseline To characterize darbepoetin alfa pharmacokinetics (PK) To assess safety and tolerability;Primary end point(s): Change in hemoglobin value from baseline to End of Treatment Period (EOTP). The baseline hemoglobin value is the value measured on study day 1 prior to first administration of IP. The EOTP hemoglobin value is defined as the last hemoglobin value during the treatment period that is not within a 28 day window following a RBC transfusion. | — |
Countries
Belgium
Outcome results
None listed