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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. |
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Register:
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EUCTR |
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Last refreshed on:
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25 November 2019 |
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Main ID: |
EUCTR2005-005484-28-GB |
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Date of registration:
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24/03/2006 |
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Prospective Registration:
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Yes |
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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 |
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Date of first enrolment:
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28/03/2006 |
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Target sample size:
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224 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005484-28 |
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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: 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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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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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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Slovakia
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Spain
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United Kingdom
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Contacts
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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 non-measurable 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
• International Normalization Ratio (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:
-Prior malignancy other than NSCLC, unless have been treated with curative intent with no evidence of disease for =3yrs
-Untreated or unstable central nervous system (CNS) metastases.
Subjects with CNS metastases that are both definitively treated and stably controlled are eligible for cohorts A and B of the phase 2 part of the study if all of the following apply:1) definitive therapy has been administered (surgery and/or radiation therapy);2) there is no additional treatment planned for brain metastases;3) the subject is clinically stable;4) the subject is off corticosteroids or on a stable dose of corticosteroids for at least 2wks 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) within 1yr of enrollment
-Uncontrolled hypertension defined as: systolic blood pressure =150mm 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 1yr of enrollment
-Recent major surgical procedure within 28dys prior to enrollment or not yet recovered from prior major surgery
-Recent minor surgical procedure or core biopsy = 7 days prior to enrollment or not yet recovered from prior minor surgery. (Insertion vascular access device is not considered major or minor surgery).
-Subjects must not have serious non-healing wound ulcer, or bone fracture within
21dys prior to enrollment
-Persistent history of gross hemoptysis (defined as bright red blood of a ½tspn or more) relating to subject’s NSCLC
-Known (documented in medical notes) HIV infection
-Active infection on day of enrollment
-Known to be hep C positive OR hep B surface antigen positive
-Subjects with Gilbert’s syndrome
Within 7 days prior to enrollment the following test results must be obtained,
unless otherwise specified:
-Absolute neutrophil count (ANC) <1.5x109/L (without granulocyte-colony stimulating factor support within 2wks of enrollment)
-Platelet count <100x109 L (without transfusion within 2wks of enrollment)
-Hemoglobin <9g/dL (subjects may be transfused or receive erythropoietic treatment to meet criterion)
-Urine protein quantitative value of >1+ on dipstick or >30mg/dL in urinalysis. If
quantitative protein is <500mg in 24hr urine collection then subject can be included
-Significant liver dysfunction as defined by aspartate aminotransferase (AST) or alanine aminotransferase (ALT)>2.5xupper limits of normal (ULN)
-Alkaline phosphatase >2.5xULN, or alkaline phosphatase >5xULN in the presence of bone or liver metastasis
-Total bilirubin >1.5XULN
-Calculated creatinine clearance <50mL/min.
-Hypercalcemia (serum calcium =12.0mg/dL or symptomatic)
-Prior chemotherapy (except for adjuvant chemotherapy, provided the last dose of adjuvant therapy was received at least one year prior to enrollment), hormonal therapy, ra
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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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.
To characterize the pharmacokinetics of AMG 951.
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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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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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