A Comparison of Continuous Avastin (Bevacizumab) Treatment or Placebo in Addition to Lomustine Followed by Standard of Care After Disease Progression in Patients With Glioblastoma

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Disease Information

Descriptive Information
Brief Title † A Comparison of Continuous Avastin (Bevacizumab) Treatment or Placebo in Addition to Lomustine Followed by Standard of Care After Disease Progression in Patients With Glioblastoma
Official Title † A Double-blind, Placebo-controlled, Randomized, Phase IIIb Trial Evaluating the Efficacy and Safety of Addition of Continuous Multiple Line Bevacizumab Treatment to Lomustine in Second (2nd)-Line Followed by Standard of Care (SOC) in Third (3rd)-Line and Beyond Compared to Addition of Placebo, Following First Progression of Disease (PD1) in Patients With Glioblastoma (GBM) After First (1st)-Line Treatment With Radiotherapy, Temozolomide and Bevacizumab
Brief Summary This multicenter, double-blind, placebo-controlled, randomized study will evaluate the efficacy and safety of the addition of Avastin (bevacizumab) or placebo treatment to lomustine in second-line treatment and standard of care (SOC) in third-line treatment following disease progression after first-line treatment in patients with newly diagnosed glioblastoma. All enrolled patients will receive first-line treatment with radiotherapy, temozolomide and Avastin (10 mg/kg/week intravenously (iv) every 2 weeks). At the first disease progression (PD1), eligible patients will be randomized to receive lomustine plus either Avastin (10 mg/kg/week iv every 2 weeks) or placebo for 2nd-line treatment. After further disease progression (PD2), patients will receive a standard of care agent and continued Avastin or placebo for 3rd-line treatment.
Detailed Description
Study Phase Phase 2
Study Type † Interventional
Study Design † Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary Outcome Measure † Overall survival, defined as time from randomization (at PD1) to death from any cause
Secondary Outcome Measure † Second-line progression-free survival
Condition † Glioblastoma
Intervention † RadiationRadiotherapy
Study Arms / Comparison Groups 1st-line treatment Run-in phase / all enrolled patients Post-PD1, Avastin + lomustine (2nd-line)/SOC (3rd-line) Post-randomization Post-PD1, placebo + lomustine (2nd-line)/SOC (3rd-line) Post-randomization
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Radiation
Estimated Enrollment † 298
Start Date † September 2013
Completion Date July 2016
Primary Completion Date July 2016
Eligibility Criteria † Inclusion Criteria: - Adult patients >/= 18 years of age - Newly diagnosed, histologically confirmed glioblastoma not previously treated with chemotherapy or radiotherapy - If female and not postmenopausal (/= 60 - Mandatory tissue collection during pre-study surgery or biopsy for confirmation of the diagnosis and pathology - Craniotomy or intracranial biopsy site must be adequately healed. Study treatment should be initiated > 28 days following the last surgical procedure Principal eligibility criteria at the time of randomization (following PD1) - Documented disease progression - Eligibility for 2nd-line treatment with lomustine and bevacizumab as investigational medicinal products - Patients for whom operation or re-operation is indicated before 2nd-line treatment starts, tissue submission is mandatory - Eastern Cooperative Oncology Group (ECOG) performance status is 0-2 when starting 2nd-line treatment - Bevacizumab was well tolerated and treatment interruption lasted not more than 60 days Exclusion Criteria: - Any prior chemotherapy for glioblastoma and low grade astrocytomas - Any prior radiotherapy to the brain or prior radiotherapy resulting in a potential overlap in the radiation field - Prior or current anti-angiogenic treatment - Treatment with any other investigational drug within 28 days or 2 investigational agent half-lives (whichever is longer) prior to first study treatment - Inadequate hematological, renal or liver function - Inadequately controlled hypertension - Prior history of gastrointestinal perforation or abscess - Clinically significant cardiovascular disease, NYHA >/= Grade II congestive heart failure, or serious cardiac arrhythmia uncontrolled by medication or potentially interfering with protocol treatment - History or evidence of central nervous system disease unrelated to cancer unless adequately treated with standard medical therapy - History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding - Serious non-healing wound, active ulcer, or untreated bone fracture - Known hypersensitivity to any component of Avastin/placebo or any of the study drugs - Active infection requiring intravenous antibiotics at start of study treatment - Other malignancy within 5 years prior to study enrollment, except for carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer or ductal carcinoma in situ treated with curative intent - Pregnant or lactating women - Participation in any other study
Gender Both
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts †† Reference Study ID Number: MO28347, 888-662-6728 (U.S. Only),
Location Countries † Austria
Administrative Information
NCT ID † NCT01860638
Organization ID MO28347
Secondary IDs †† 2012-003138-17
Responsible Party Sponsor
Study Sponsor † Hoffmann-La Roche
Collaborators ††
Investigators † Study Director: Clinical Trials, Hoffmann-La Roche
Information Provided By
Verification Date August 2015
First Received Date † May 21, 2013
Last Updated Date August 17, 2015
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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