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BAY86-9766 MEK Inhibitor+ Sorafenib

Phase 2

Carcinoma, Hepatocellular | Small molecule | Oncology |Bayer AG|Last Updated: Sep 6, 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment70

FDA Designations

No designations recorded

Clinical trial landscape

BAY86-9766 MEK Inhibitor+ Sorafenib · 1 trial · 1 indication

Phase 2 1
NCT01204177Assessing BAY86-9766 Plus Sorafenib for the Treatment of Liver Cancer.Carcinoma, Hepatocellular
COMPLETED70 Analytics
PHASE2COMPLETED
Assessing BAY86-9766 Plus Sorafenib for the Treatment of Liver Cancer.
Carcinoma, HepatocellularUnlock trial analytics

Study Endpoints

Primary Endpoints

Disease Control Rate (DCR)
From first dose of combination treatment until last tumor evaluation

Secondary Endpoints

Overall Survival (OS)
1st dose of study medication to last date of follow up
Time To Progression (TTP)
1st dose of study medication until disease progression
Response Rate (RR)
1st dose of study medication until last tumor evaluation
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -

Interventions

NameTypeDescription
BAY86-9766 MEK Inhibitor + SorafenibDRUGAll 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)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites15

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 ...

Countries:Hong KongSingaporeSouth KoreaTaiwan
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Frequently asked questions about BAY86-9766 MEK Inhibitor+ Sorafenib

What is BAY86-9766 MEK Inhibitor+ Sorafenib used for?

BAY86-9766 MEK Inhibitor+ Sorafenib is used for the treatment of hepatocellular carcinoma, a type of liver cancer. It is a combination therapy being studied in patients with this condition. The drug is currently in clinical development and is not yet approved for general use.

What does BAY86-9766 MEK Inhibitor+ Sorafenib target?

BAY86-9766 is a MEK inhibitor, meaning it targets MEK, a protein involved in cell signaling pathways that regulate cell growth and division. Sorafenib, the other component, is a kinase inhibitor that targets multiple kinases. Together, they are being studied for their combined effect in hepatocellular carcinoma.

Who makes BAY86-9766 MEK Inhibitor+ Sorafenib?

BAY86-9766 MEK Inhibitor+ Sorafenib is developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded under the ticker symbol BAYRY on the OTC market. The company is conducting clinical trials to evaluate this combination therapy for liver cancer.

What phase is BAY86-9766 MEK Inhibitor+ Sorafenib in?

BAY86-9766 MEK Inhibitor+ Sorafenib is in Phase 2 clinical development. This phase is designed to assess the drug's efficacy and safety in a larger group of patients. The drug is investigational and has not been approved by regulatory authorities for commercial use.

What clinical trials is BAY86-9766 MEK Inhibitor+ Sorafenib in?

BAY86-9766 MEK Inhibitor+ Sorafenib has been studied in one completed Phase 2 trial, identified as NCT01204177. This trial, titled 'Assessing BAY86-9766 Plus Sorafenib for the Treatment of Liver Cancer,' enrolled 70 patients with hepatocellular carcinoma across Hong Kong, Singapore, South Korea, and Taiwan.

Is BAY86-9766 MEK Inhibitor+ Sorafenib the same as other drugs?

BAY86-9766 MEK Inhibitor+ Sorafenib is a combination of two drugs: BAY86-9766, a MEK inhibitor, and sorafenib, a multi-kinase inhibitor. Sorafenib is also known by the brand name Nexavar. BAY86-9766 is the investigational component, and the combination is being studied specifically for hepatocellular carcinoma.