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Terminated/Withdrawn
Sponsor ID
20030205

A Study of AMG 114 Administered by Subcutaneous Injection for the Treatment of Anemia in Subjects with Non-Myeloid Malignancies Receiving Multicycle Chemotherapy

Sponsor ID
20030205
Clinicaltrials.gov ID
NCT00119600
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 1/Phase 2
Product
AMG 114
Type
Interventional
Masking
N/A
Enrollment
N/A
Additional Study Details

Protocol Summary

Primary Outcome Measures
Not Available
Secondary Outcome Measures
Not Available

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Anemia
  • Cancer - Other
    • Sex
    All
    Trial Dates
    Apr 2004 - N/A
    Inclusion and Exclusion Criteria
    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