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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31 August 2015 |
Main ID: |
EUCTR2013-000738-36-ES |
Date of registration:
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08/08/2013 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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The trial is designed to determine the efficacy and safety of ABP 215 compared with Bevacizumab in subjects with advanced non-small cell lung cancer
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Scientific title:
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A Randomized, Double-Blind, Phase 3 Study Evaluating the Efficacy and Safety OF ABP 215 Compared with Bevacizumab in Subjects with Advanced Non-Small Cell Lung Cancer - Not Applicable |
Date of first enrolment:
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17/10/2013 |
Target sample size:
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620 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000738-36 |
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: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Countries of recruitment
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Australia
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Belgium
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Bulgaria
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Canada
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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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Hungary
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Italy
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Mexico
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Netherlands
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Poland
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Romania
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Russian Federation
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Spain
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Taiwan
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Turkey
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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 Info-Clinical Trials
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Address:
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Dammstrasse 23, PO Box 1557
CH-6300
Zug
Switzerland |
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 Info-Clinical Trials
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Address:
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Dammstrasse 23, PO Box 1557
CH-6300
Zug
Switzerland |
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: 1. Males and females ? 18 and < 80 years of age 2. Histologically or cytologically confirmed non-squamous non-small cell lung cancer 3. Stage 4 or recurrent metastatic NSCLC with measurable disease according to modified Response Evaluation Criteria in Solid Tumors (RECIST v1.1). For subjects with recurrent disease, at least 12 months must have elapsed since completing adjuvant chemotherapy. Subjects must have had a baseline scan (computed tomography [CT] or magnetic resonance imaging [MRI]) of the chest and abdomen to assess disease burden before enrolling in study and receiving first-line chemotherapy for NSCLC. If the scan was performed more than 28 days prior to randomization, an additional scan must be obtained 4. Subjects must be initiating first-line carboplatin/paclitaxel chemotherapy within 8 days after randomization and expected to receive at least 4 cycles of chemotherapy 5. ECOG performance status score 0 or 1 6. Normal bone marrow function as defined by: . ? absolute neutrophil count (ANC) ? 1.5 x 109 g/dL (1,500/?L) . ? platelets ? 100 x 109 g/dL (100,000/?L) . ?hemoglobin ? 100 g/L (10.0 g/dL) 7. Adequate hepatic function as defined by: . < total bilirubin < 1.5 × the upper limit of normal (ULN) . 8. Adequate renal function as defined by creatinine < 1.5 × ULN 9. Subjects must sign an IRB/EC-approved informed consent form before any study specific procedures 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 435 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 185
Exclusion criteria: 1. Small cell lung cancer (SCLC) or mixed SCLC and NSCLC
2. Mixed adenosquamous carcinomas with a predominantly squamous component
3. Central nervous system (CNS) metastases
4. Tumor invading or compressing major blood vessels or tumor cavitation
5. Malignancy other than NSCLC
6. Palliative radiotherapy for bone lesions inside the thorax
7. Prior radiotherapy of bone marrow
8. Minor surgical procedure or core biopsy before randomization, or not yet recovered from prior minor surgery
9. Major surgery within 4 weeks before randomization or not yet recovered from prior surgery
10. Planned major surgical procedure during the treatment phase
Any of the following before randomization: ·clinically significant cardiovascular disease; peripheral vascular disease, cerebrovascular accident or transient ischemic attack ·history of hemoptysis ·history of thrombotic or hemorrhagic disorders
12. Proteinuria
13 Coagulation abnormalities or systemic anticoagulation or chronic aspirin therapy
14. Medically uncontrolled hypertension or systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg
15. Any unhealed wound or bone fracture
16. Clinically significant peripheral neuropathy
17. Significant weight loss
18. Any known co-morbid disease that would increase the risk of toxicity
19. Known to be positive for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
20. Recent infection requiring a course of systemic anti-infectives
21. Life expectancy < 6 months
22. Woman of child-bearing potential who is pregnant or is breast feeding or who is not consenting to use highly effective methods of birth control during treatment and for an additional 6 months after the last administration of the protocol specified treatment
23. Man with a partner of childbearing potential who does not consent to use highly effective methods of birth control during treatment and for an additional 6 months after the last administration of the protocol specified treatment
25. Other investigational procedures while participating in this study
26. Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)
27. Subject has known sensitivity to any of the products to be administered during the study, including mammalian cell derived drug products
28. Subject has previously been randomized in this study
29. Subject likely to not be available to complete all protocol required study visits or procedures
30. History or evidence of any other clinically significant disorder, condition
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Advanced Non-small Cell Lung Cancer MedDRA version: 16.0
Level: PT
Classification code 10061873
Term: Non-small cell lung cancer
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: ABP 215 Product Code: ABP 215 Pharmaceutical Form: Solution for infusion INN or Proposed INN: N/A Current Sponsor code: ABP 215 Other descriptive name: biosimilar product to bevacizumab Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25-
Trade Name: Avastin Product Name: Avastin Pharmaceutical Form: Solution for injection INN or Proposed INN: BEVACIZUMAB CAS Number: 216974-75-3 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25-
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Primary Outcome(s)
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Secondary Objective: To assess the safety and immunogenicity of ABP 215 compared with bevacizumab.
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Main Objective: To compare the efficacy of ABP 215 with bevacizumab.
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Timepoint(s) of evaluation of this end point: ORR is assessed every 6 weeks. The actual endpoint is best response seen during the study.
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Primary end point(s): Risk ratio of the incidence of overall response rate (ORR)
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Assessed at the end of the study.
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Secondary end point(s): - Risk difference of the incidence of ORR -Duration of response (DOR) -Progression-free survival (PFS) Safety Criteria: -Treatment-emergent adverse events -Treatment-emergent serious adverse events -Incidence of anti-drug antibodies -Overall survival (OS)
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Secondary ID(s)
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2013-000738-36-HU
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20120265
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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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