Assessing BAY86-9766 Plus Sorafenib for the Treatment of Liver Cancer.
NCT ID: NCT01204177
Last Updated: 2013-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
70 participants
INTERVENTIONAL
2010-12-31
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
BAY86-9766 MEK Inhibitor + Sorafenib
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)
Interventions
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BAY86-9766 MEK Inhibitor + Sorafenib
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)
Eligibility Criteria
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Inclusion Criteria
* 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 results during the screening period
* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
* Patients must have at least one naïve (not previously treated by locoregional therapy) uni-dimensional measurable lesion by CT or MRI according to RECIST 1.1
* Adequate bone marrow, liver and renal function
Exclusion Criteria
* History of cardiac disease: Congestive heart failure (CHF), unstable angina, arrhythmias, Uncontrolled hypertension
* Clinically significant GI bleeding (CTCAE grade 3 or higher) within 30 days
* Renal failure requiring hemo- or peritoneal dialysis
* Known human immunodeficiency virus (HIV) infection
* Known history or symptomatic metastatic brain or meningeal tumors
* History of organ allograft.
* History of interstitial lung disease (ILD).
* Excluded previous therapies and medications:
* Prior use of systemic anti-cancer treatment for HCC including cytotoxic chemotherapy, targeted agents, or any experimental therapy
* Radiotherapy within 4 weeks prior to start of study treatment
* Any other investigational agents within 4 weeks from the first dose of study treatment
* Major surgery within 4 weeks of start of study
* Concomitant use of strong inhibitors and strong inducers of CYP3A4
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Shatin, New Territories, Hong Kong
Hong Kong, , Hong Kong
Singapore, , Singapore
Singapore, , Singapore
Junggu, Daegu Gwang''yeogsi, South Korea
Goyang-si, Gyeonggido, South Korea
Busan, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Kaohsiung City, , Taiwan
Tainan City, , Taiwan
Tainan City, , Taiwan
Taipei, , Taiwan
Countries
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References
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Lim HY, Heo J, Choi HJ, Lin CY, Yoon JH, Hsu C, Rau KM, Poon RT, Yeo W, Park JW, Tay MH, Hsieh WS, Kappeler C, Rajagopalan P, Krissel H, Jeffers M, Yen CJ, Tak WY. A phase II study of the efficacy and safety of the combination therapy of the MEK inhibitor refametinib (BAY 86-9766) plus sorafenib for Asian patients with unresectable hepatocellular carcinoma. Clin Cancer Res. 2014 Dec 1;20(23):5976-85. doi: 10.1158/1078-0432.CCR-13-3445. Epub 2014 Oct 7.
Other Identifiers
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14899
Identifier Type: -
Identifier Source: org_study_id