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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2004-000645-37-DK |
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Date of registration:
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09/07/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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25/08/2004 |
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Target sample size:
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400 |
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000645-37 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product:
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Denmark
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Spain
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Sweden
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Part A:
• subjects with non-myeloid malignancies receiving non-platinum containing chemotherapy only
• anemia (hemoglobin concentration of = 8.5 g/dL and = 10.5 g/dL)
• planned 6 weeks of multicycle chemotherapy
Part B and C:
• subjects with non-myeloid malignancies
• anemia (hemoglobin concentration = 11.0 g/dL)
• planned 12 weeks of multicycle chemotherapy
Part A, B and C:
• of legal age of consent (= 18 years of age)
• = 6 month life expectancy
• ECOG performance status 0 to 2
• adequate renal function
• adequate liver function
• able to give written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Part A, B and C:
• ANC < 0.8X 109 cells/L
• iron deficiency
• received > 2 RBC transfusions within 28 days or any RBC transfusion within 14 days before randomisation
• received any erythropoietic therapy within 28 days before randomisation
• history of any seizure disorder
• primary hematologic disorder which could cause anemia
• active infection or inflammatory disease
• unstable angina, congestive heart failure or uncontrolled cardiac arrhythmia
• uncontrolled hypertension
• history of pure red cell aplasia
• randomised previously into any part of this study
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Treatment of anemia in cancer subjects with non-myeloid malignancies receiving multicycle chemotherapy
MedDRA version: 7.0
Level: PT
Classification code 10049105
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Intervention(s)
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Product Code: AMG 114
Pharmaceutical Form: Solution for injection
Current Sponsor code: AMG 114
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Code: AMG 114
Pharmaceutical Form: Solution for injection
Current Sponsor code: AMG 114
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Code: AMG 114
Pharmaceutical Form: Solution for injection
Current Sponsor code: AMG 114
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Code: AMG 114
Pharmaceutical Form: Solution for injection
Current Sponsor code: AMG 114
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Code: AMG 114
Pharmaceutical Form: Solution for injection
Current Sponsor code: AMG 114
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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Secondary Objective: To determine the clinically effective fixed dose of AMG 114 to treat chemotherapy induced anemia
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Main Objective: To evaluate the safety, tolerability and pharmacokinetics (PK) of AMG 114 administered subcutaneously for the treatment of chemotherapy induced anemia in subjects receiving multicycle chemotherapy
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Primary end point(s): Part A
Safety Endpoint: incidence of adverse events, serious adverse events
Pharmacokinetic endpoint: non-compartmental PK parameters
Part B and Part C
Safety Endpoint: incidence of adverse events, serious adverse events
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Secondary ID(s)
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20030205
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2004-000645-37-SE
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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