Main
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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:
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EUCTR |
Last refreshed on:
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3 July 2017 |
Main ID: |
EUCTR2007-005792-34-AT |
Date of registration:
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06/05/2009 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Study to Evaluate the Long-term Safety and
Efficacy of Darbepoetin Alfa Administered at 500 mcg Once-Every-3-Weeks (Q3W) in Anemic
Subjects With Advanced Stage Non-small Cell Lung Cancer Receiving Multi-cycle
Chemotherapy
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Scientific title:
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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
(Q3W) in Anemic Subjects With Advanced Stage Non-small Cell Lung Cancer Receiving
Multi-cycle Chemotherapy. |
Date of first enrolment:
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30/07/2009 |
Target sample size:
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3000 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-005792-34 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Austria
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Belgium
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Brazil
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Bulgaria
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Canada
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Chile
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China
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Croatia
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Czech Republic
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Germany
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Greece
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Hong Kong
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India
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Ireland
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Israel
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Italy
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Mexico
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Netherlands
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Philippines
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Russian Federation
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Serbia
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Slovenia
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South Africa
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Spain
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Switzerland
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Taiwan
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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IHQ Medical Information – Clinical
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Address:
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240 Cambridge Science Park, Milton Road
CB4 0WD
Cambridge
United Kingdom |
Telephone:
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Email:
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MedinfoInternational@amgen.com |
Affiliation:
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Amgen (EUROPE) GmbH |
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Name:
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IHQ Medical Information – Clinical
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Address:
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240 Cambridge Science Park, Milton Road
CB4 0WD
Cambridge
United Kingdom |
Telephone:
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Email:
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MedinfoInternational@amgen.com |
Affiliation:
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Amgen (EUROPE) GmbH |
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Key inclusion & exclusion criteria
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Inclusion criteria: Disease Related
• Subjects with stage IV NSCLC (not recurrent or re-staged)
• Expected to receive at least 2 additional cycles (at least 6 total weeks) of first line myelosuppressive cyclic chemotherapy after randomization. Subjects should not be expected to receive only maintenance chemotherapy.
Demographic
• Eastern Cooperative Oncology Group performance status of 0 or 1 as assessed within 21 days prior to randomization
• 18 years of age or older at screening.
• Life expectancy > 6 months based on the judgment of the investigator and documented during screening.
Laboratory
• Hemoglobin level = 11.0 g/dL as assessed by the local laboratory;
sample obtained within 7 days prior to randomization (retest in screening is acceptable).
• Adequate serum folate (= 2 ng/mL) and vitamin B12 (= 200 pg/mL) levels assessed by central laboratory (supplementation and retest acceptable) during screening.
Imaging
• Subjects must have had a baseline scan (CT, MRI, or PET/CT) of the chest to assess disease burden before starting on first line chemotherapy for NSCLC and those images must have been reviewed
by the investigator prior to randomization. If the scan was performed more than 28 days prior to randomization, an additional scan must be performed and reviewed by the investigator to confirm that the patient has not progressed before randomization.
Ethical
• Before any study-specific procedure, the appropriate written informed consent must be obtained from the subject or a 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 1800 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1200
Exclusion criteria: Disease Related
• Known primary benign or malignant hematologic disorder which can cause anemia.
• History of, or current active cancer other than NSCLC, 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.
• Received any prior adjuvant or neoadjuvant therapy for NSCLC
• Subjects with a history of brain metastasis.
• Uncontrolled hypertension (systolic BP > 160 mmHg or diastolic BP > 100 mmHg), or as determined by the investigator during 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 randomization.
• Subjects with a history of seizure disorder taking anti-seizure medication within 30 days prior to randomization.
• Clinically significant systemic infection or uncontrolled chronic inflammatory disease (eg, rheumatoid arthritis, inflammatory bowel disease) as determined by the investigator during screening.
• Known seropositivity for HIV or diagnosis of 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 randomization.
Laboratory
• Transferrin saturation < 20% and ferritin < 50 ng/mL as assessed by the
central laboratory during screening. Subjects must have both to be
excluded supplementation and retest acceptable).
• Abnormal renal function (serum creatinine level > 2X ULN) as assessed by
the central laboratory during screening.
• Abnormal liver function (total bilirubin > 2X ULN or liver enzymes ALT or AST > 2.5X ULN for subjects without liver metastasis or = 5X ULN for subjects with liver metastasis) as assessed by the central laboratory during screening.
Subjects with documented Gilbert’s Disease may be eligible.
Medications
• Received any RBC transfusion within 28 days prior to randomization.
• Plan to receive any RBC transfusion between randomization and study day 1.
• Known previous treatment failure to ESAs (eg, rHuEPO, darbepoetin alfa).
• ESA therapy within the 28 days prior to randomization.
• Known hypersensitivity to recombinant ESAs or the excipients contained within the investigational product.
General
• 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 country’s 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).
• Previously randomized to 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
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
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Anemia in subjects with advanced stage non-small cell lung cancer receiving multi-cycle chemotherapy. MedDRA version: 20.0
Level: LLT
Classification code 10064469
Term: Anemia post chemotherapy
System Organ Class: 100000004851
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Intervention(s)
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Product Name: Darbepoetin alfa 100µg solution for injection Pharmaceutical Form: Solution for injection INN or Proposed INN: Darbepoetin alfa 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 Name: Darbepoetin alfa 200µg solution for injection Pharmaceutical Form: Solution for injection INN or Proposed INN: Darbepoetin alfa 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 Name: Darbepoetin alfa 300µg solution for injection Pharmaceutical Form: Solution for injection INN or Proposed INN: Darbepoetin alfa Concentration unit: µg/ml microgram(s)/millilitre 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 alfa 500µg solution for injection Pharmaceutical Form: Solution for injection INN or Proposed INN: Darbepoetin alfa Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 500- 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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Timepoint(s) of evaluation of this end point: Survival status will be assessed every 3 months ± 2weeks.
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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.
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Primary end point(s): Overall survival
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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.
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Secondary Outcome(s)
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Secondary end point(s): Progression-free survival (PFS)
Incidence of at least 1 RBC transfusion or hemoglobin = 8.0 g/dL from week 5 (day 29) to the end of the efficacy treatment period (EOETP; defined as 21 days after either the last dose of IP or the last dose of chemotherapy, whichever is later; the EOETP will be set to the EOTP if the EOETP exceeds the EOTP)
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Timepoint(s) of evaluation of this end point: Assessment of progression-free survival, RBC transfusions and Hb at: screening; Day1/Week; Weeks 4, 7, 10, 13, 16, 19, 22, 25, 28... during the treatment period.; at last dose of IP; and at next Q3W visit after disease progression
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Secondary ID(s)
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20070782
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2007-005792-34-GB
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NCT00858364
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Source(s) of Monetary Support
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Amgen Inc.
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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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