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BAY86-9766 MEK Inhibitor+ Sorafenib · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BAY86-9766 MEK Inhibitor + Sorafenib | DRUG | All patients who meet the entry criteria will receive BAY86-9766 50mg (2x20mg + 1x10mg capsules) twice daily in combination with sorafenib 800 mg (2x200 mg tablets bid). During the first 3 weeks they will receive a reduced dose of sorafenib: 600 mg / daily (1x200mg tablet in the morning + 2x200mg tablets in the evening) daily. This dose will be increased to the standard dose of 800 mg (400 mg bid) if no major side effects occur. Treatment until PD or until one of the withdrawal criteria for this study is met as described in the protocol (e.g. radiological progression or clinical progression) |
Inclusion Criteria: * Male or Female age \>/= 18 years of age * Life expectancy \>/= 12 weeks * Histologically or cytologically confirmed diagnosis of HCC, unresectable advanced or metastatic * Liver function status of Child-Pugh class A. Child-Pugh status based on clinical findings and laboratory ...
BAY86-9766 MEK Inhibitor + Sorafenib was studied for the treatment of hepatocellular carcinoma, a form of liver cancer. The combination pairs a MEK inhibitor with sorafenib, a multikinase inhibitor used in liver cancer. It was evaluated in adults aged 18 years and older with this condition.
Bayer AG is the developer of BAY86-9766 MEK Inhibitor + Sorafenib. Bayer trades on the OTC market under the ticker BAYRY. The company sponsored the clinical program evaluating this combination in hepatocellular carcinoma.
BAY86-9766 MEK Inhibitor + Sorafenib reached Phase 2 clinical development. The program's single Phase 2 trial has completed, and no trials of this combination are currently active. It is an investigational regimen and is not an approved therapy.
The combination was studied in trial NCT01204177, titled Assessing BAY86-9766 Plus Sorafenib for the Treatment of Liver Cancer. This completed Phase 2 trial enrolled 70 participants with hepatocellular carcinoma across Hong Kong, Singapore, South Korea, and Taiwan. It was an uncontrolled study open to all sexes.
The Phase 2 trial of BAY86-9766 MEK Inhibitor + Sorafenib, NCT01204177, enrolled 70 participants with hepatocellular carcinoma. Enrollment was limited to adults 18 years and older, and healthy volunteers were not included. The study was conducted in Hong Kong, Singapore, South Korea, and Taiwan.