Treatment of anemia in cancer subjects with non-myeloid malignancies receiving multicycle chemotherapy MedDRA version: 7.0 Level: PT Classification code 10049105
Conditions
Interventions
Product Code: AMG 114
Pharmaceutical Form: Solution for injection
Current Sponsor code: AMG 114
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Ph
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Part A: • subjects with non-myeloid malignancies receiving non-platinum containing chemotherapy only • anemia (hemoglobin concentration of = 8.5 g/dL and = 10.5 g/dL) • planned 6 weeks of multicycle chemotherapy Part B and C: • subjects with non-myeloid malignancies • anemia (hemoglobin concentration = 11.0 g/dL) • planned 12 weeks of multicycle chemotherapy Part A, B and C: • of legal age of consent (= 18 years of age) • = 6 month life expectancy • ECOG performance status 0 to 2 • adequate renal function • adequate liver function • able to give written informed consent 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Part A, B and C: • ANC 2 RBC transfusions within 28 days or any RBC transfusion within 14 days before randomisation • received any erythropoietic therapy within 28 days before randomisation • history of any seizure disorder • primary hematologic disorder which could cause anemia • active infection or inflammatory disease • unstable angina, congestive heart failure or uncontrolled cardiac arrhythmia • uncontrolled hypertension • history of pure red cell aplasia • randomised previously into any part of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety, tolerability and pharmacokinetics (PK) of AMG 114 administered subcutaneously for the treatment of chemotherapy induced anemia in subjects receiving multicycle chemotherapy;Secondary Objective: To determine the clinically effective fixed dose of AMG 114 to treat chemotherapy induced anemia;Primary end point(s): Part A Safety Endpoint: incidence of adverse events, serious adverse events Pharmacokinetic endpoint: non-compartmental PK parameters Part B and Part C Safety Endpoint: incidence of adverse events, serious adverse events | — |
Countries
Denmark, Spain, Sweden
Outcome results
None listed