Trial Condition(s):
Assessing BAY86-9766 plus sorafenib for the treatment of liver cancer. (BASIL)
14899
Not Available
Not Available
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.
- 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 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
- Previous or concurrent cancer other than HCC, except for cervical carcinoma in situ, basal cell carcinoma, superficial bladder tumors. - 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
Locations | |
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Locations OncoCare Cancer Centre Singapore, Singapore, 258499 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Singapore Oncology Consultations Singapore, Singapore, 228510 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chi-Mei Medical Center, Liouyine Tainan, Taiwan, China, 736 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National Taiwan University Hospital Taipei, Taiwan, China, 100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National Cheng Kung University Hospital Tainan, Taiwan, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chang Gung Memorial Hospital Kaohsiung Kaohsiung, Taiwan, China, 833 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Prince of Wales Hospital Shatin, Hong Kong, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Queen Mary Hospital Hong Kong, Hong Kong, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Samsung Medical Center Seoul, South Korea, 135-710 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Asan Medical Center Seoul, South Korea, 138-736 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seoul National University Hospital Seoul, South Korea, 110-744 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National Cancer Center Goyang-si , South Korea, 410-769 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kyungpook National University Hospital Jung-gu, South Korea, 700-721 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pusan National University Hospital Busan, South Korea, 602-739 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Yonsei University College of Medicine Seoul, South Korea, 120-752 | Contact Us: E-mail: [email protected] Phone: Not Available |
A phase II trial of BAY86-9766 plus sorafenib as first line systemic treatment for hepatocellular carcinoma (HCC)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1