Status:
COMPLETED
A Comparison of Continuous Bevacizumab (Avastin) Treatment or Placebo in Addition to Lomustine Followed by Standard of Care After Disease Progression in Participants With Glioblastoma
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This multicenter, double-blind, placebo-controlled, randomized study will evaluate the efficacy and safety of the addition of bevacizumab treatment to lomustine (in 2nd-line \[2L\] treatment) and SOC ...
Eligibility Criteria
Inclusion
- Inclusion Criteria at Enrollment (before PD1):
- Newly diagnosed, histologically confirmed glioblastoma not previously treated with chemotherapy or radiotherapy
- If female and not postmenopausal (less than \[\<\] 12 months of amenorrhea) or surgically sterile, must agree to use a highly effective contraceptive method during the treatment period and for at least 6 months after the last dose of study drug
- Karnofsky performance status (KPS) greater than or equal to (\>/=) 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
- Inclusion Criteria at Randomization (following PD1):
- Documented PD1 according to RANO criteria
- Eligibility for second-line treatment with lomustine and bevacizumab as investigational medicinal products
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Bevacizumab well tolerated and not interrupted for longer than 60 days during first-line treatment
- Tissue submission among participants for whom operation/re-operation is indicated before second-line treatment starts; operation/re-operation performed \>/=28 days after last bevacizumab administration and second-line treatment initiated \>/=28 days after surgical wound healed
- Randomization within 28 days after PD1 among participants for whom operation/re-operation is not necessary
- First administration of second-line treatment no later than 2 days from randomization
- Exclusion Criteria at Enrollment (before PD1):
- 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
- 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 bevacizumab/placebo or any of the study drugs
- Active infection requiring IV 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
Exclusion
Key Trial Info
Start Date :
August 19 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2017
Estimated Enrollment :
296 Patients enrolled
Trial Details
Trial ID
NCT01860638
Start Date
August 19 2013
End Date
May 5 2017
Last Update
April 30 2018
Active Locations (64)
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1
Medizinische Universität Graz; Universitätsklinik für Neurologie
Graz, Austria, 8036
2
Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie
Innsbruck, Austria, 6020
3
Kepler Universitätsklinikum GmbH - Neuromed Campus; Innere Medizin mit Neuroonkologie
Linz, Austria, 4020
4
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
Salzburg, Austria, 5020