Status:
COMPLETED
AVAPERL1 Study: A Study of Avastin (Bevacizumab) With or Without Pemetrexed as Maintenance Therapy After Avastin in First Line in Patients With Non-Squamous Non-Small Cell Lung Cancer
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Non-Squamous Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This open-label study will assess the efficacy and safety of Avastin with or without pemetrexed as maintenance therapy in patients with advanced, metastatic or recurrent non-small cell lung cancer. In...
Eligibility Criteria
Inclusion
- adults \>/=18 years of age
- inoperable, locally advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC)
- at least 1 measurable lesion meeting RECIST criteria
- ECOG performance status 0-2
- adequate hematological, liver and renal function
Exclusion
- prior chemotherapy or treatment with another systemic anti-cancer agent
- 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 or DCIS
- evidence of tumor invading major blood vessels
- current or recent use of aspirin (\>325mg/day) or full-dose anticoagulants or thrombolytic agents for therapeutic purposes
- history of haemoptysis \>/=grade 2
- clinically significant cardiovascular disease
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
376 Patients enrolled
Trial Details
Trial ID
NCT00961415
Start Date
August 1 2009
End Date
May 1 2011
Last Update
February 22 2016
Active Locations (91)
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1
Béziers, France, 34500
2
Bordeaux, France, 33077
3
Bron, France, 69677
4
Caen, France, 14033