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

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

Status
Terminated
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00119600
Enrollment
Unknown
Registered
2005-07-14
Start date
Unknown
Completion date
Unknown
Last updated
2009-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Cancer

Keywords

Non-myeloid malignancy, Clinical Trial

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.

Interventions

DRUGAMG 114

Sponsors

Amgen
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Incidence and severity of adverse events—
Change in hemoglobin concentration—
Maximum observed concentration (Cmax)—
Time Cmax is observed (Tmax)—
AUC—

Secondary

MeasureTime frame
Change in FACT-fatigue sub-scores—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026