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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

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ClinicalTrials.gov Identifier: NCT00119600
Recruitment Status : Terminated
First Posted : July 14, 2005
Last Update Posted : May 11, 2009
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Anemia Cancer Drug: AMG 114 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia
U.S. FDA Resources




Primary Outcome Measures :
  1. Incidence and severity of adverse events
  2. Change in hemoglobin concentration
  3. Maximum observed concentration (Cmax)
  4. Time Cmax is observed (Tmax)
  5. AUC

Secondary Outcome Measures :
  1. Change in FACT-fatigue sub-scores


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00119600


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00119600     History of Changes
Other Study ID Numbers: 20030205
First Posted: July 14, 2005    Key Record Dates
Last Update Posted: May 11, 2009
Last Verified: May 2009

Keywords provided by Amgen:
Non-myeloid malignancy
Clinical Trial

Additional relevant MeSH terms:
Anemia
Neoplasms
Hematologic Diseases