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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021795-29 |
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This open-label, multicenter study will evaluate the safety and efficacy of RO5323441 in combination with Avastin (bevacizumab) in patients with recurrent glioblastoma. In the dose-finding part, patients will receive intravenous escalating doses of RO5323441 in combination with 10 mg/kg Avastin once every two weeks. In the efficacy-finding part, patients will be randomized to receive the established dose (from the dose-finding part) of RO5323441 plus Avastin or Avastin alone. Patients in the dose-finding part may continue treatment with RO5323441 and Avastin on the study until evidence of progressive disease or unacceptable adverse events happen. In the efficacy-finding part, patients will receive study treatment until disease progression or death.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO5323441 + bevacizumab [Avastin] | Drug | Dose-Finding part: RO5323441 intravenous escalating doses once every two weeks; Efficacy-Finding part: established dose from the Dose-Finding part; Avastin: 10 mg/kg intravenously once every two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-Finding Part: Dose limiting toxicity | Day 28 | |
| Efficacy-Finding part: Progression-free survival | From baseline to disease progression or death (>12 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-Finding part: Pharmacokinetics of RO5323441 and Avastin when combined | From baseline to disease progression or death (>12 months) | |
| Dose-Finding part: Safety (incidence of adverse events) | From baseline to disease progression or death (>12 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| København Ø | 2100 | Denmark | ||||
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| bevacizumab [Avastin] | Drug | Efficacy-Finding part: 10 mg/kg intravenously once every two weeks |
|
| Dose-Finding part: Efficacy (tumor response according to Response Assessment in Neurooncology (RANO) criteria | From baseline to disease progression or death (>12 months) |
| Dose-Finding part: Glioblastoma biomarker | From baseline to disease progression or death (>12 months) |
| Efficacy-Finding part: Overall Response Rate | From baseline to disease progression or death (>12 months) |
| Efficacy-Finding part: Disease Control Rate | From baseline to disease progression or death (>12 months) |
| Efficacy-Finding part: Duration of Response | From baseline to disease progression or death (>12 months) |
| Efficacy-Finding part: Progression-free survival | From baseline to disease progression or death (>12 months) |
| Efficacy-Finding part: Overall Survival | From baseline to disease progression or death (>12 months) |
| Efficacy-Finding part: Safety (incidence of adverse events) | From baseline to disease progression or death (>12 months) |
| Efficacy-Finding part: Glioblastoma biomarker | From baseline to disease progression or death (>12 months) |
| Efficacy-Finding part: Pharmacokinetics (serum levels) of RO5323441 and Avastin when combined | From baseline to disease progression or death (>12 months) |
| Marseille |
| 13385 |
| France |
| Zurich | 8091 | Switzerland |
| Manchester | M2O 4BX | United Kingdom |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| C569915 | TB-403 |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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