This study investigates the safety and efficacy of the combination therapy with BAY86-9766 and sorafenib in patients with liver cancer. Safety will be determined by laboratory and other evaluations. Efficacy of the combination BAY86-9766 and sorafenib will be determined by disease control rate, overall survival, time to progression, response rate and duration of response.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
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)
Unnamed facility
Shatin, New Territories, Hong Kong
Unnamed facility
Hong Kong, Hong Kong
Unnamed facility
Singapore, Singapore
Unnamed facility
Disease Control Rate (DCR)
Time frame: From first dose of combination treatment until last tumor evaluation
Overall Survival (OS)
Time frame: 1st dose of study medication to last date of follow up
Time To Progression (TTP)
Time frame: 1st dose of study medication until disease progression
Response Rate (RR)
Time frame: 1st dose of study medication until last tumor evaluation
Duration Of Response (DOR)
Time frame: 1st dose of study medication until last tumor evaluation
Safety: physical examination, vital signs, adverse events, safety lab
Time frame: At day 1, 8, 15 of cycle 1 and 2 and day 1 of each next cycle until 30 days after EOT
Patients reported hepatobiliary cancer symptoms and Health Related Quality of Life (HRQoL)
Time frame: At day 1 of each cycle and within 7 day after the last treatment
Pharmacokinetic (PK) profiles of BAY86-9766 and sorafenib to evaluate drug exposure (not in all patients)
Time frame: Day -3, cycle 2 (day 1)
Biomarkers
Time frame: At screening, day 1 of cycle 1 - 4, EOT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Singapore, Singapore
Unnamed facility
Junggu, Daegu Gwang''yeogsi, South Korea
Unnamed facility
Goyang-si, Gyeonggido, South Korea
Unnamed facility
Busan, South Korea
Unnamed facility
Seoul, South Korea
Unnamed facility
Seoul, South Korea
Unnamed facility
Seoul, South Korea
...and 5 more locations