Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RO5323441 · 3 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| Part I | EXPERIMENTAL | - |
| Part II (A) | EXPERIMENTAL | - |
| Part II (B) | ACTIVE_COMPARATOR | - |
| Single Arm | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| 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 |
| bevacizumab [Avastin] | DRUG | Efficacy-Finding part: 10 mg/kg intravenously once every two weeks |
| RO5323441 | DRUG | escalating doses iv |
| sorafenib | DRUG | 400 mg orally twice daily to once every other day |
Inclusion Criteria: * Adult patients, \>/=18 years of age * Histologically confirmed glioblastoma * Radiographic demonstration of disease progression by Response Assessment in Neurooncology (RANO) criteria following prior therapy * Availability of at least 1 formalin-fixed paraffin-embedded tumor t...
RO5323441 is an investigational small molecule oncology drug developed by Roche Holding AG. It has been studied in Phase 1 clinical trials in several solid tumor types, including hepatocellular carcinoma, colorectal cancer, ovarian cancer, and glioblastoma multiforme. It is not an approved therapy and remains in clinical development.
RO5323441 has been studied in Phase 1 trials for hepatocellular carcinoma, colorectal cancer, ovarian cancer, and glioblastoma multiforme. In these studies it was given in combination with other agents, including sorafenib in hepatocellular carcinoma and bevacizumab (Avastin) in recurrent glioblastoma. It is investigational and not approved for any indication.
RO5323441 is developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche sponsored the Phase 1 studies of the compound in hepatocellular carcinoma, colorectal cancer, ovarian cancer, and glioblastoma multiforme.
RO5323441 is in Phase 1. All three of its recorded clinical trials were Phase 1 studies, and all have been completed. The drug is investigational and has not been approved by the FDA for any indication.
RO5323441 has been evaluated in three completed Phase 1 trials. NCT01308723 tested it with sorafenib in hepatocellular carcinoma in Singapore. NCT01308684 tested it with bevacizumab (Avastin) in recurrent glioblastoma across Denmark, France, Switzerland, and the United Kingdom. NCT01148758 studied it in metastatic treatment-refractory colorectal or ovarian cancer in Belgium, Spain, and the United Kingdom.