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
Inclusion Criteria:
Part A: - Non-myeloid malignancy receiving multicycle chemotherapy -
Receiving non-platinum containing chemotherapy - At least 6 additional weeks of cyclic
cytotoxic chemotherapy planned Part B and Part C: - Non-myeloid malignancy receiving
multicycle chemotherapy - At least 12 additional weeks of cyclic cytotoxic chemotherapy
planned All Parts: - Chemotherapy induced anemia - Greater than 6 month life expectancy -
ECOG 0-2 - Adequate renal and liver function Exclusion Criteria: - Chronic myeloid
leukemia, AML, ALL, Burkitt's lymphoma or lymphoblastic lymphoma - History of seizure
disorder - Primary hematologic disorder which could cause anemia, other than a non-myeloid
malignancy - Unstable angina, congestive heart failure or uncontrolled cardiac arrhythmia
- Uncontrolled hypertension - History of pure red cell aplasia - Clinically significant
inflammatory disease or active infection - Iron deficiency - ANC less than 0.8 x 10^9
cells/L