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

This study has been terminated.

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00119600

Purpose

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.

Condition	Intervention	Phase
Anemia Cancer	Drug: AMG 114	Phase I Phase II

MedlinePlus related topics: Anemia Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Pharmacokinetics Study
Official Title:	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

Further study details as provided by Amgen:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Change in FACT-fatigue sub-scores

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119600

Sponsors and Collaborators

Amgen

Investigators

Study Director:

Amgen

More Information

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20030205
Study First Received:	July 6, 2005
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00119600
Health Authority:	Australia: Human Research Ethics Committee

Keywords provided by Amgen:

Non-myeloid malignancy
Clinical Trial

Study placed in the following topic categories:

Signs and Symptoms
Hematologic Diseases
Anemia

ClinicalTrials.gov processed this record on January 16, 2009