Status:
COMPLETED
A Study of Avastin (Bevacizumab) And Fotemustine in Patients With Recurrent Glioblastoma
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This randomized, non-comparative study will evaluate the efficacy and safety of Avastin (bevacizumab) in patients with recurrent glioblastoma. Patients will be randomized to receive Avastin 10 mg/kg i...
Eligibility Criteria
Inclusion
- Adult patients, \>/=18 years of age
- Diagnosis of recurrent glioblastoma multiforme (Grade IV)
- Previous treatment with temozolomide and radiotherapy
- First recurrence after standard adjuvant treatment (surgery, followed by radiotherapy and chemotherapy)
- Adequate hematological, biochemical and organ functions
Exclusion
- Previous treatment with Avastin or other anti-angiogenic drugs
- Residual relevant toxicity resulting from previous therapy
- Radiotherapy within the 3 months prior to the diagnosis of disease progression
- Chemotherapy in the previous 4 weeks
- Other active or inactive malignancies (except for carcinoma in situ of the cervix, of the prostate or basal cell carcinoma)
- Clinically significant cardiovascular diseases
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT01474239
Start Date
November 1 2011
End Date
December 1 2013
Last Update
March 15 2016
Active Locations (10)
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1
San Giovanni Rotondo, Apulia, Italy, 71013
2
Napoli, Campania, Italy, 80131
3
Bologna, Emilia-Romagna, Italy, 40133
4
Rome, Lazio, Italy, 00168