A Study of Avastin (Bevacizumab) in Combination With Temozolomide and Radiotherapy in Patients With Newly Diagnosed Glioblastoma
Tracking InformationStart Date ICMJE | June 2009 |
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Primary Completion Date | |
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Current Primary Outcome Measures ICMJE (submitted: July 21, 2009) | - Overall survival [ Time Frame: Assessments in weeks 10,18, 26 and 34 and at 9-weekly intervals thereafter ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: Assessments in weeks 10,18, 26 and 34 and at 9-weekly intervals thereafter ] [ Designated as safety issue: No ]
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Original Primary Outcome Measures ICMJE | Same as current |
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Change History | Complete list of historical versions of study NCT00943826 on ClinicalTrials.gov Archive Site |
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Current Secondary Outcome Measures ICMJE (submitted: July 21, 2009) | - Survival rates [ Time Frame: 1 year and 2 years ] [ Designated as safety issue: No ]
- Health-related quality of life [ Time Frame: Assessments in weeks 10, 18, 26 and 34 and at 9-weekly intervals thereafter ] [ Designated as safety issue: No ]
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Original Secondary Outcome Measures ICMJE | Same as current |
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Descriptive InformationBrief Title ICMJE | A Study of Avastin (Bevacizumab) in Combination With Temozolomide and Radiotherapy in Patients With Newly Diagnosed Glioblastoma |
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Official Title ICMJE | A Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy of Bevacizumab, Radiotherapy and Temozolomide (TMZ) Followed by Bevacizumab and TMZ, Versus Placebo Radiotherapy and TMZ Followed by Placebo and TMZ on Survival in Patients With Newly Diagnosed Glioblastoma |
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Brief Summary | This 2 arm study will investigate the efficacy and safety of the addition of bevacizumab (Avastin) to the current standard of care (multimodality therapy of concurrent radiotherapy plus temozolomide followed by adjuvant temozolomide) as compared to the current standard of care alone. Patients will be randomly assigned to either the Avastin (10mg/kg iv q2w)or the placebo arm, in combination with radiation therapy (total dose 60 Gy, administered as 2 Gy fractions, 5 days/week)plus temozolomide (75mg/m2po daily) for 6 weeks.After a 4 week treatment break,patients will continue to receive Avastin (10mg/kg iv q2w) or placebo, plus temozolomide (150-200mg/m2 po daily on days 1-5 of each 4 week cycle) for 6 cycles of maintenance treatment. Following the maintenance phase,Avastin (15mg/kg iv q3w) or placebo monotherapy will continue. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals. |
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Detailed Description | |
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Study Phase | Phase III |
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Study Type ICMJE | Interventional |
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Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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Condition ICMJE | Glioblastoma |
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Intervention ICMJE | - Drug: bevacizumab [Avastin]
10mg/kg iv q2w - Drug: Placebo
iv q2w - Drug: temozolomide
75mg/m2 po once daily for 6 weeks, followed by 150-200mg/m2 po daily on days 1-5 of each 6 x 4 week cycle - Radiation: Radiation therapy
30 fractions of 2 Gy delivered on days 1-5 per week for 6 weeks
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Study Arms / Comparison Groups | - 1: Experimental
Interventions: - Drug: bevacizumab [Avastin]
- Drug: temozolomide
- Radiation: Radiation therapy
- 2: Placebo Comparator
Interventions: - Drug: Placebo
- Drug: temozolomide
- Radiation: Radiation therapy
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Recruitment InformationEstimated Enrollment ICMJE | 920 |
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Estimated Completion Date | October 2014 |
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Primary Completion Date | |
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Eligibility Criteria ICMJE | Inclusion Criteria: - adult patients, >=18 years of age;
- newly diagnosed glioblastoma;
- WHO performance status <=2;
- stable or decreasing corticosteroid dose within 5 days prior to randomization.
Exclusion Criteria: - evidence of recent hemorrhage or postoperative MRI of brain;
- any prior chemotherapy or immunotherapy for glioblastomas and low grade astrocytomas;
- any prior radiotherapy to brain;
- clinically significant cardiovascular disease;
- history of >=grade 2 hemoptysis within 1 month prior to randomization;
- previous centralized screening for MGMT status for enrollment into a clinical trial.
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Gender | Both |
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Ages | 18 Years and older |
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Accepts Healthy Volunteers | No |
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Contacts ICMJE | Contact: Please reference Study ID Number: BO21990 | 973-235-5000 | | | Contact: or | 800-526-6367 (FOR US ONLY) | | |
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Location Countries ICMJE | United States, Australia, Belgium, Canada, Denmark, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Republic of, Netherlands, New Zealand, Poland, Portugal, Romania, Russian Federation, Spain, Sweden, Switzerland, United Kingdom |
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Administrative InformationNCT ID ICMJE | NCT00943826 |
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Responsible Party | Clinical Trials, Study Director, Hoffmann-La Roche |
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Study ID Numbers ICMJE | BO21990, 2008-006146-26 |
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Study Sponsor ICMJE | Hoffmann-La Roche |
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Collaborators ICMJE | |
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Investigators ICMJE | Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 | |
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Information Provided By | Hoffmann-La Roche |
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