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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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9 October 2012 |
Main ID: |
EUCTR2008-000662-23-DE |
Date of registration:
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20/06/2008 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Scientific title:
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A randomized, multicenter phase II study to explore whether biomarkers correlate with treatment outcome in chemo-naive patients with advanced or recurrent non-squamous non-small cell lung cancer, who receive treatment with bevacizumab (at a dose of either 7.5 mg/kg or 15 mg/kg) in addition to carboplatin based chemotherapy (gemcitabine or paclitaxel) - ABIGAIL |
Date of first enrolment:
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08/01/2009 |
Target sample size:
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300 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-000662-23 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Czech Republic
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Denmark
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France
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Germany
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Hungary
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Italy
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Netherlands
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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: Age 18 years or above Life expectancy > 12 weeks Able to comply with the protocol Histologically or cytologically documented inoperable, locally advanced (stage IIIb with supraclavicular lymph node metastases or malignant pleural or pericardial effusion), metastatic (stage IV) or recurrent non-squamous NSCLC. Diagnoses of non-squamous NSCLC based on sputum cytology alone are not acceptable. Mixed tumors should be categorized according to the predominant cell type At least one measurable tumor lesion according to the RECIST criteria ECOG performance status 0-1 Adequate hematological function: ANC = 1.5 x 109/L; platelets = 100 x 109/L, Hb = 9 g/dL INR < or = 1.5 (or PT within normal range) and aPTT < or = 1.5 x ULN within 7 days prior to starting study treatment Adequate liver function: Serum bilirubin < or = 1.5 x ULN; transaminases < or = 2.5 x ULN (in the presence of liver metastases :< 5 x ULN) Adequate renal function: Creatinine clearance, measured and/or calculated according to the formula of Cockroft and Gault = 50 mL/min AND Urine dipstick for proteinuria < 2+. If urine dipstick is = 2+, 24- hour urine must demonstrate < or = 1 g of protein in 24 hours Negative serum pregnancy test within 7 days of starting study treatment in pre-menopausal women and women < 2 years after the onset of menopause 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 chemotherapy or treatment with another systemic anti cancer agent (for example monoclonal antibodies, tyrosine kinase inhibitors) NOTE: prior surgery is permitted if the criteria below do not apply: Surgery (including open biopsy) or significant traumatic injury within the last 4 weeks prior to first dose or anticipation of the need for major surgery during study treatment. Minor surgical procedures within 2 days prior randomization Radiotherapy within the 4 weeks prior to the first dose Patients who have had radiotherapy = 4 weeks prior to the first dose of study treatment, but are experiencing acute toxic effects of radiotherapy Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component •History of = grade 2 hemoptysis (bright red blood of at least 2.5 mL) History of peripheral sensory neuropathy of Grade 2 or more Evidence of CNS metastases, even if previously treated Evidence of tumor invading or abutting major blood vessels Pregnant or lactating women Fertile men or women of childbearing potential not using adequate contraception Malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, DCIS treated surgically with curative intent Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to starting study treatment Known hypersensitivity to any of the study drugs Non-healing wound, ulcer (including peptic ulcer) or bone fracture History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding Active gastrointestinal bleeding Uncontrolled hypertension systolic > 150 mmHg and/or diastolic > 100 mmHg Clinically significant cardiovascular disease to include but not restricted to for example CVA (< or = 6 months before randomization), myocardial infarction (< or = 6 months before randomization), unstable angina, NYHA =grade 2 CHF, arrhythmia uncontrolled by medication Current or recent (within 10 days of first dose) use of aspirin (> 325 mg/day) clopidogrel > 75 mg/day, or treatment with dipyramidole, ticlopidine, and cliostazol Current or recent (within 10 days prior to study treatment start) use of full dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (not prophylactic) purposes Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contra-indicates the use of an investigational drug or puts the patient at high risk of treatment-related conditions Increased risk of gastrointestinal perforation, hypertension, would healing complications, thromboembolism or hemorrhage (for thromboembolism and hemorrhage risk, this concerns risks other than those related to NSCLC per se) Active infection requiring iv antibiotics at randomization History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of randomization
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Locally advanced, metastatic or recurrent Non-small Cell Lung Cancer MedDRA version: 9.1
Level: LLT
Classification code 10061873
Term: Non-small cell lung cancer
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Intervention(s)
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Trade Name: Avastin Product Name: bevacizumab Product Code: RO 4876646 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: bevacizumab CAS Number: 216974 Current Sponsor code: RO4876646 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25-
Trade Name: Avastin Product Name: bevacizumab Product Code: RO 4876646 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: bevacizumab CAS Number: 216974 Current Sponsor code: RO4876646 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25-
Trade Name: Gemzar Product Name: gemcitabine Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: GEMCITABINE CAS Number: 95058814 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200-
Trade Name: Gemzar Product Name: gemcitabine Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: GEMCITABINE CAS Number: 95058814 Concentration unit: g gram(s) Concentration type: equal Concentration number: 1-
Trade Name: Carboplatin Product Name: carboplatin Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: CARBOPLATIN CAS Number: 41575944 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10-
Trade Name: Oncotax or any other brand Product Name: paclitaxel Product Code: RO-024-7506 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: PACLITAXEL CAS Number: 33069624 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6-
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Primary Outcome(s)
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Secondary Objective: Secondary: To evaluate PFS in patients treated with carboplatin based chemotherapy in combination with bevacizumab To evaluate response rate, disease control rate and duration of response (RECIST) To evaluate Overall Survival To evaluate the safety profile Exploratory: Explore changes in biomarkers Explore the correlation of biomarkers with response rate as assigned by the independent radiological review (according to RECIST criteria) Explore the correlation of response rate according to RECIST with tumor volume changes as assessed by HRCT To evaluate whether genetic variants of VEGF A and VEGF receptors affect pharmacodynamic/efficacy/safety parameters To explore the relationship between bevacizumab exposure and biomarkers
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Main Objective: Explore the correlation of biomarkers with response rate as assessed by the investigator (according to RECIST) in patients treated with carboplatin based chemotherapy in combination with 7.5 mg/kg or 15 mg/kg of bevacizumab
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Primary end point(s): Exploration of the correlation of biomarkers with response rate as assessed by the investigator (according to RECIST) in patients treated with carboplatin based chemotherapy in combination with 7.5 mg/kg or 15 mg/kg of bevacizumab. Primary parameters are the levels of the biomarker the primary biomarkers at baseline
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Secondary ID(s)
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BO21015
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2008-000662-23-NL
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Source(s) of Monetary Support
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Results
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Results available:
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