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

• Conditions: Treatment of anemia in cancer subjects with non-myeloid malignancies receiving multicycle chemotherapy; MedDRA version: 7.0Level: PTClassification code 10049105

• Registration Number: EUCTR2004-000645-37-ES
• Lead Sponsor: Amgen Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 390

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

Part A, B and C:
• ANC < 0.8X 109 cells/L
• iron deficiency
• received > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>Safety Endpoint: incidence of adverse events, serious adverse events<br>Pharmacokinetic endpoint: non-compartmental PK parameters<br>Part B and Part C<br>Safety Endpoint: incidence of adverse events, serious adverse events<br>