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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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18 April 2012 |
Main ID: |
EUCTR2005-005484-28-IE |
Date of registration:
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10/09/2007 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Multicenter, Open Label, Randomized Study of AMG 951 in Subjects with Previously Untreated Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC) Treated with Chemotherapy with or without Bevacizumab
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Scientific title:
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A Multicenter, Open Label, Randomized Study of AMG 951 in Subjects with Previously Untreated Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC) Treated with Chemotherapy with or without Bevacizumab |
Date of first enrolment:
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02/11/2007 |
Target sample size:
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224 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005484-28 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Czech Republic
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Finland
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Ireland
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Italy
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Netherlands
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Poland
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Spain
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion criteria: Disease related -Histologically or cytologically confirmed Non-Small Cell Lung Cancer (NSCLC). Mixed tumors will be categorized by the predominant cell type unless small cell elements are present in which case the patient is ineligible. Cytologic or histologic elements can be established on metastatic tumor aspirates or biopsy. -Subjects must have advanced NSCLC defined as stage IIIb with malignant pleural effusion or Stage IV or recurrent disease. Subjects with unmeasurable but evaluable disease can be included in the phase 1b study, but disease must be measurable to be included in the phase 2 study -Planning to receive up to 6 cycles of chemotherapy • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 (see Appendix F) • Life expectancy greater than 3 months
Demographic: • =18 years old and of legal age for informed consent • Subjects must sign and date a written Independent Ethics Committee (IEC)- approved Informed Consent Form
Laboratory • INR = 1.2 and PTT = ULN within 1 week prior to enrollment 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: Disease Related: -Prior malignancy other than NSCLC (except in situ basal cell carcinoma or in situ cervical cancer), unless have been treated with curative intent with no evidence of disease for =3yrs -Untreated or unstable central nervous system (CNS) metastases. Subjects with treated and stably controlled CNS metastases are eligible for cohorts A&B of the phase 2 part of the study if definitive therapy has been administered (surgery and/or radiation therapy), there is no planned treatment for brain metastases, and the subject is clinically stable and is off corticosteroids or on a stable dose of corticosteroids for at least 2 wks prior to enrollment -Myocardial infarction, or unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure [New York Heart Association >class II]) within 1 yr of enrollment -Uncontrolled hypertension defined as: systolic blood pressure =150 mm Hg OR diastolic blood pressure =100mm Hg (antihypertensive therapy to achieve these parameters is allowable) -History of arterial thrombosis, pulmonary embolus, deep vein thrombosis or hemorrhagic disorders within 1 yr of enrollment -Recent major surgical procedure within 28 days of enrollment -Subjects must not have serious non-healing wound ulcer, or bone fracture within 21 days prior to enrollment -Persistent history of gross hemoptysis (defined as bright red blood of a ½teaspoon or more) relating to subject’s NSCLC -Known (documented in medical notes) HIV infection -Active infection on day of enrollment -Known to be hepatitis C positive OR hepatitis B surface antigen positive -Subjects with Gilbert’s syndrome Laboratory: -Absolute neutrophil count (ANC) <1.5 x 109 /L (without granulocyte-colony stimulating factor support within 2 wks of enrollment) -Platelet count <100 x 109 /L (without transfusion within 2 wks of enrollment) -Hemoglobin <9 g/dL (subjects may be transfused or receive erythropoietic treatment to meet criterion) -Urine protein quantitative value of >1+ on dipstick or =30 mg/dL in urinalysis. If quantitative protein is <500 mg in 24hr urine collection then subject can be included -Significant liver dysfunction as defined by aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 x upper limits of normal (ULN) -Alkaline phosphatase >2.5 x ULN, or alkaline phosphatase >5 x ULN in the presence of bone or liver metastasis -Total bilirubin >1.5 X ULN -Calculated creatinine clearance <50mL/min. -Hypercalcemia (serum calcium =12.0 mg/dL or symptomatic) Medication: -Prior chemotherapy (except for adjuvant chemotherapy, provided the last dose of adjuvant therapy was received at least one year prior to enrollment), hormonal therapy, radiotherapy (except palliative radiotherapy for bone metastases or radiation therapy for CNS metastases) or immunotherapy for treatment of advanced NSCLC -Prior drug treatment or therapy with investigational agents for NSCLC -Therapeutic anticoagulation treatment. Prophylactic anticoagulation of venous access devices (e.g., with low-dose warfarin [1-2 mg/day] or lowdose heparin) is allowed providing INR =1.2 and PTT =ULN within 1 wk prior to randomization -Chronic daily treatment with aspirin (>325 mg/day) or non-steroidal antiinflammatory agents known to inhibit platelet function. Treatment with dipyridamole, ticlopidine, clopidogrel and/or cilostazol is also not allowed General: -Participation in clinical trials or undergoing other inves
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Subjects with Previously Untreated Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC) Treated with Chemotherapy with or without Bevacizumab MedDRA version: 8.1
Level: LLT
Classification code 10029521
Term: Non-small cell lung cancer stage IIIB
MedDRA version: 9.1
Level: LLT
Classification code 10029522
Term: Non-small cell lung cancer stage IV
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Intervention(s)
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Product Name: Apo2L/TRAIL (AMG951) Product Code: AMG 951 Pharmaceutical Form: Powder for solution for infusion Current Sponsor code: AMG 951 Other descriptive name: Apo2L/TRAIL Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100-
Trade Name: Avastin Product Name: Bevacizumab Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Bevacizumab Other descriptive name: Avastin Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25-
Product Name: Apo2L/TRAIL (AMG 951) Product Code: AMG 951 Pharmaceutical Form: Powder for solution for infusion Current Sponsor code: AMG 951 Other descriptive name: Apo2L/TRAIL Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300-
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Primary Outcome(s)
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Main Objective: Phase 1b Primary Objective: To determine the maximum tolerated dose (MTD) (up to 8 mg/kg/day for 5 days treatment and up to 20mg/kg/day for 2 days treatment) through safety and tolerability of multiple doses of AMG 951 administered by intravenous (IV) infusion to subjects with NSCLC in combination with chemotherapy and bevacizumab.
Phase 2 Primary Objective: To evaluate the objective response rate (CR and PR) by modified RECIST for AMG 951 at varying dose schedules in combination with carboplatin / paclitaxel + bevacizumab for subjects with NSCLC.
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Primary end point(s): Incidence of dose-limiting toxicities (DLTs) Incidence and severity of adverse events (Phase 1b)
Objective response rate (complete or partial response) (Phase 2)
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Secondary Objective: Phase 1b Secondary Objective: To characterize the pharmacokinetics of AMG 951 (to include but not limited to AUC, Cmax, t1/2, clearance, and volume of distribution).
Phase 2 Secondary Objectives: To evaluate overall response rate (CR, PR and SD), progression-free survival, time to response, duration of response, time to progression and overall survival for AMG 951 at varying dose schedules.
To evaluate the safety profile of AMG 951 at varying dose schedules.
To evaluate the formation of anti-AMG 951 antibodies.
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Secondary ID(s)
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20050190
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2005-005484-28-GB
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Source(s) of Monetary Support
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Results
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Results available:
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