A Study of AMG 114 Administered by Subcutaneous Injection for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy
Phase 1
Terminated
- Conditions
- AnemiaCancer
- Registration Number
- NCT00119600
- Lead Sponsor
- Amgen
- Brief Summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of AMG 114 administered subcutaneously for the treatment of chemotherapy induced anemia in subjects receiving multicycle chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method AUC Incidence and severity of adverse events Change in hemoglobin concentration Maximum observed concentration (Cmax) Time Cmax is observed (Tmax)
- Secondary Outcome Measures
Name Time Method Change in FACT-fatigue sub-scores