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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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7 January 2013 |
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Main ID: |
EUCTR2005-005484-28-IT |
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Date of registration:
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11/11/2008 |
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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 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 - 20050190
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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 - 20050190 |
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Date of first enrolment:
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13/12/2007 |
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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: no
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:
Placebo:
Other:
Other specify the comparator: - same IMP used at different dosage
Number of treatment arms in the trial: 5
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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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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
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 • ECOG performance status of 0 or 1 • Life expectancy greater than 3 months • `?¥ 18 years old • Subjects must sign and date a written Independent Ethics Committee (IEC)-approved Informed Consent Form • 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: 0
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 (except in situ basal cell carcinoma or in situ cervical cancer), unless have been treated with curative intent with no evidence of disease for `?¥ 3 years • 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 2 weeks prior to enrollment • Myocardial infarction, or unstable or uncontrolled disease or condition related to or impacting cardiac function (eg, unstable angina, congestive heart failure [New York Heart Association > class II]) within 1 year of enrollment • Uncontrolled hypertension defined as: systolic blood pressure `?¥ 150 mm Hg OR diastolic blood pressure `?¥ 100 mm Hg (antihypertensive therapy to achieve these parameters is allowable) • History of arterial thrombosis, pulmonary embolus, deep vein thrombosis or hemorrhagic disorders within 1 year of enrollment - Recent major surgical procedure within 28 days prior to enrollment or not yet recovered from prior major surgery (For the full list see protocol.)
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 patients with stage IIIb/IV non-small cell lung cancer
MedDRA version: 14.1
Level: PT
Classification code 10029522
Term: Non-small cell lung cancer stage IV
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 14.1
Level: PT
Classification code 10029521
Term: Non-small cell lung cancer stage IIIB
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Therapeutic area: Diseases [C] - Cancer [C04]
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Intervention(s)
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Product Name: AMG 951
Product Code: NA
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: AMG 951
Concentration unit: mg milligram(s)
Concentration number: 300-
Product Name: Avastin
Product Code: NA
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Bevacizumab
Concentration unit: mg/kg milligram(s)/kilogram
Concentration number: 15-
Product Name: Avastin
Product Code: NA
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: AMG 951
Concentration unit: mg milligram(s)
Concentration number: 300-
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Primary Outcome(s)
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Main Objective: To evaluate the objective response rate (Complete Response (CR) and Partial Response (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: To evaluate overall response rate (CR, PR and Stable Disease (SD)), progression-free survival (PFS), time to response, duration of response, time to progression (TTP) 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): Objective response rate (complete or partial response)
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Secondary ID(s)
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2005-005484-28-GB
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AMG95120050190
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Source(s) of Monetary Support
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Results
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Results available:
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