A Randomised, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Finding Study of AMG 114 Administered by Subcutaneous Injection for the Treatment of Anemia in Subjects With Non-myeloid Malignancies Receiving Multicycle Chemotherapy

INTERVENTION: 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‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use 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: 50‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use 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: 100‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use 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: 200‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use 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: 400‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use CONDITION: Treatment of anemia in cancer subjects with non‐myeloid malignancies receiving multicycle chemotherapy ; MedDRA version: 7.0 Level: PT Classification code 10049105 PRIMARY OUTCOME: 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 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; Secondary Objective: To determine the clinically effective fixed dose of AMG 114 to treat chemotherapy induced anemia 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