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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.
Register: EUCTR
Last refreshed on: 19 February 2018
Main ID:  EUCTR2007-005792-34-IT
Date of registration: 09/11/2009
Prospective Registration: No
Primary sponsor: Amgen Inc
Public title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long-term Safety and Efficacy of Darbepoetin Alfa Administered at 500 μg Once-Every-3-Weeks in Anemic Subjects With Advanced Stage Non-small Cell Lung Cancer Receiving Multi-cycle Chemotherapy. - ND
Scientific title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long-term Safety and Efficacy of Darbepoetin Alfa Administered at 500 μg Once-Every-3-Weeks in Anemic Subjects With Advanced Stage Non-small Cell Lung Cancer Receiving Multi-cycle Chemotherapy. - ND
Date of first enrolment: 28/10/2009
Target sample size: 3000
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-005792-34
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Austria Belgium Bulgaria Czech Republic Germany Greece Ireland Italy
Netherlands Slovenia Spain United Kingdom
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
Subjects with metastatic (stage IV) or advanced stage IIIB with malignant pleural effusion
NSCLC
Receiving or about to receive first line cyclic chemotherapy for NSCLC and expected to
receive at least 2 additional cycles of cyclic chemotherapy
Life expectancy > 6 months based on the judgment of the investigator and documented at
screening
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 as assessed at
screening
18 years of age or older at screening
Subjects with chemotherapy-induced anemia as defined as having a hemoglobin
level ≤ 11.0 g/dL at screening. If screening takes more than 7 days, a confirming hemoglobin
level must be performed within 7 days of randomization
Subjects must have a pre-chemotherapy hemoglobin value (obtained within 4 weeks prior to
starting first line chemotherapy for NSCLC) documented.
Subjects must have had a baseline scan (chest and upper abdominal CT, MRI, or PET/CT) to
assess disease burden before starting on first line chemotherapy for NSCLC and those
images must be available to the investigator
Adequate serum folate (≥ 2 ng/mL) and vitamin B12 (≥ 200 pg/mL) levels at screening
assessed by central laboratory (supplementation and retest acceptable)
Before any study specific procedure, the appropriate written informed consent must be
obtained from the subject or legally accepted representative
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:
Known primary benign or malignant hematologic disorder which can cause anemia
History of, or current, active cancer (other than non-small cell lung), with the exception of
curatively resected non-melanomatous skin cancer, curatively treated cervical carcinoma in
situ, or other primary solid tumors curatively treated with no known active disease present
and no curative treatment administered for the last 3 years
Subjects with a history of brain metastasis
Uncontrolled hypertension (systolic blood pressure [BP] > 160 mmHg or diastolic BP
> 100 mmHg), or as determined by the investigator at screening
History of neutralizing antibody activity to rHuEPO or darbepoetin alfa
Uncontrolled angina, uncontrolled heart failure, or uncontrolled cardiac arrhythmia as
determined by the investigator at screening. Subjects with known myocardial infarction within
6 months prior to screening
Subjects with a history of seizure disorder taking anti-seizure medication within 30 days of
screening
Clinically significant systemic infection or uncontrolled chronic inflammatory disease (eg,
rheumatoid arthritis, inflammatory bowel disease) at the time of screening as determined by
the investigator
Known seropositivity for human immunodeficiency virus (HIV), or diagnosis of acquired
immunodeficiency syndrome (AIDS). Positive for hepatitis B surface antigen, or seropositive
for hepatitis C virus
History of pure red cell aplasia
History of deep venous thrombosis or embolic event (eg, pulmonary embolism) within 6
months prior to screening
Known previous treatment failure to ESAs (eg, rHuEPO, darbepoetin alfa)
ESA therapy within the 28 days prior to screening
Known hypersensitivity to recombinant ESAs or the excipients contained within the
investigational product
Transferrin saturation < 20% and ferritin < 50 ng/mL at screening. Subjects must have both
to be excluded (supplementation and retest acceptable)
Abnormal renal function (serum creatinine level > 2 times the upper limit of normal [ULN]) at
screening
Abnormal liver function (total bilirubin > 2X ULN and liver enzymes alanine aminotransferase
[ALT] or aspartate aminotransferase [AST] > 2.5X ULN for subjects without liver metastasis
or ≥ 5X ULN for subjects with liver metastasis) at screening. Subjects with documented
Gilberts Disease may be eligible
Received any RBC transfusion within 28 days prior to randomization
Plan to receive any RBC transfusion between randomization and study day 1
Less than 30 days since receipt of any investigational product or device. Investigational
use/receipt of a medicinal product or device that has been approved by the countrys local
regulatory authority for any indication is permitted
Subjects of reproductive potential who are pregnant, breast feeding or not willing to use
effective contraceptive precautions during the study and for at least one month after the last
dose of investigational product in the judgment of the investigator (including females of
childbearing potential who are partners of male subjects)
Previous randomization in this study
Investigator has concerns regarding the ability of the subject to give written informed consent
and/or to comply with study procedures (including availability for follow-up visits)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Chemotherapy-induced Anemia (CIA)
MedDRA version: 9.1 Level: LLT Classification code 10064468
Intervention(s)

Product Name: darbepoetin alpha
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Darbepoetin alfa
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use

Product Name: darbepoetin alpha
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Darbepoetin alfa
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Product Name: darbepoetin alpha
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Darbepoetin alfa
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Product Name: darbepoetin alpha
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Darbepoetin alfa
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)
Secondary Objective: To demonstrate non-inferiority of progression-free survival (PFS) when comparing subjects
on darbepoetin alfa treated to a hemoglobin ceiling of 12.0 g/dL to subjects treated with
placebo
To demonstrate superiority in reducing the incidence of red blood cell (RBC) transfusions
when comparing subjects on darbepoetin alfa treated to a hemoglobin ceiling of 12.0 g/dL to
subjects treated with placebo
To assess other safety and efficacy parameters in subjects on darbepoetin alfa treated to a
hemoglobin ceiling of 12.0 g/dL compared to subjects treated with placebo
Primary end point(s): Overall survival (OS)
Main Objective: To demonstrate non-inferiority of overall survival (OS) when comparing subjects on
darbepoetin alfa treated to a hemoglobin ceiling of 12.0 g/dL to subjects treated with placebo
Secondary Outcome(s)
Secondary ID(s)
2007-005792-34-GB
20070782
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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