Open-label study of bevacizumab AVASTIN in combination with platinum-containing chemotherapy as first-line treatment of patients with advanced or recurrent non-squamous non-small cell lung cancer. - SAIL

• Register: EUCTR
• Last refreshed on: 7 January 2013
• Main ID: EUCTR2005-005887-97-IT
• Date of registration: 08/02/2007
• Prospective Registration: No
• Primary sponsor: ROCHE
• Public title: Open-label study of bevacizumab AVASTIN in combination with platinum-containing chemotherapy as first-line treatment of patients with advanced or recurrent non-squamous non-small cell lung cancer. - SAIL
• Scientific title: Open-label study of bevacizumab AVASTIN in combination with platinum-containing chemotherapy as first-line treatment of patients with advanced or recurrent non-squamous non-small cell lung cancer. - SAIL
• Date of first enrolment: 24/10/2006
• Target sample size: 2000
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005887-97
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Austria, Czech Republic, Denmark, Estonia, Finland, Germany, Hungary, Iceland, Italy, Latvia, Lithuania, Netherlands, Portugal, Slovenia, Spain, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Written informed consent informed consent document to be approved by the institution s Independent Ethics Committee and consent obtained prior to any study-specific procedure 2. Age 18 years 3. Able to comply with the protocol 4. 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 NSCLC other than squamous cell tumours of mixed histology should be categorized by the predominant cell type 5. Eastern Cooperative Oncology Group PS status 0-2 6. Life expectancy 12 weeks 7. Adequate haematological function - Absolute neutrophil count ANC 1.5 x 109/L AND - Platelet count 100 x 109/L AND - Haemoglobin 9 g/dL may be transfused to maintain or exceed this level 8. Adequate liver function - Total bilirubin 1.5 x upper limit of normal ULN AND - Asparagine aminotransferase AST , alanine aminotransferase ALT 2.5 x ULN in patients without liver metastases; 5 x ULN in patients with liver metastases 9. Adequate renal function - Serum creatinine 1.25 x ULN or calculated creatinine clearance 50 mL/min AND - Urine dipstick for proteinuria 2 . Patientsdiscovered to have 2 proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate 1 g of protein in 24 hours 10. International normalised ratio INR 1.5 and prothrombin time PPT 1.5 x ULN within 7 days prior to enrolment 11. If female, should not be pregnant or breast-feeding. Women with an intact uterus unless amenorrhoeic for the last 24 months must have a negative serum pregnancy test within 28 days prior to enrolment into the study. If a serum pregnancy test is not performed within 7 days prior to the first dose of bevacizumab, a confirmatory urine test within 7 days prior to the first dose of bevacizumab is required
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:
1. Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component 2. History of haemoptysis, defined as bright red blood of at least half a teaspoon in the 3 months prior to enrolment 3. Evidence of tumour invading major blood vessels on imaging. The investigator or the local radiologist must exclude evidence of tumour that is fully contiguous with, surrounding, or extending into the lumen of a major blood vessel e.g. pulmonary artery or superior vena cava 4. Evidence of CNS metastases, even if previously treated. If suspected, the patient should be scanned within 28 days prior to enrolment to rule out CNS metastases 5. Neoadjuvant/adjuvant chemotherapy within 6 months prior to enrolment 6. Radiotherapy within 28 days prior to enrolment 7. Major surgery including open biopsy , significant traumatic injury within 28 days prior to enrolment or anticipation of the need for major surgery during study treatment 8. Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion 9. Current or recent within 10 days of first dose of bevacizumab use of aspirin 325mg/day 10. Current or recent within 10 days of first dose of bevacizumab use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeuticpurposes. Prophylactic use of anticoagulants is allowed 11. History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding 12. Uncontrolled hypertension blood pressures systolic 150 mmHg and/or diastolic 100 mmHg 13. Clinically significant i.e. active cardiovascular disease for example CVA 6 months before enrolment , myocardial infarction 6 months before enrolment , unstable angina, congestive heart failure NYHA Class II, serious cardiac arrhythmia requiring medication during the study and might interfere with regularity of the study treatment, or not controlled by medication 14. Non-healing wound, active peptic ulcer or bone fracture 15. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment 16. Women with an intact uterus unless amenorrhoeic or the last 24 months not using effective, nonhormonal means of contraception intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile during the study and for a period of 6 months following the last administration of bevacizumab. Men who do not agree to use effective contraception during the study and for a period of 60 days following the last administration of bevacizumab 17. Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment 18. Known hypersensitivity to bevacizumab or any of its excipients, and any of the chemotherapies 19. Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Locally advanced Stage IIIb with supraclavicular lymph node metastases or malignant pleural or pericardial effusion, metastatic or recurrent nonsquamous non-small cell lung cancer NSCLC .
MedDRA version: 6.1 Level: PT Classification code 10029521

Intervention(s)

Trade Name: AVASTIN*INFUS 1FL 100MG
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: BEVACIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Trade Name: AVASTIN*INFUS 1FL 400MG
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: BEVACIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-

Primary Outcome(s)

Main Objective: To assess the safety profile of bevacizumab when combined with chemotherapy as first-line treatment of advanced or recurrent non-squamous NSCLC.

Secondary Objective: 1. To assess the efficacy of bevacizumab as measured by time to disease progression and overall survival. 2. To assess the safety of bevacizumab in patients who develop central nervous system CNS metastases during and for 6 months following the treatment period.

Primary end point(s): The incidence of SAEs related to bevacizumab and the incidence of specific AEs serious and non-serious such as hypertension, proteinuria, wound healing complications, arterial and venous thromboembolilc events, haemoptysis, CNS bleeding, other haemorrhages, gastrointestinal perforations and CHF, are considered as primary endpoints. ECOG PS 2 patients will be analysed separately .

Secondary ID(s)

MO 19390

2005-005887-97-SI