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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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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.

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Detailed Description

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Conditions

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Anemia Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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AMG 114

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No