Trial Condition(s):

Carcinoma, Hepatocellular

Assessing BAY86-9766 plus sorafenib for the treatment of liver cancer. (BASIL)

Bayer Identifier:

14899

ClinicalTrials.gov Identifier:

NCT01204177

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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 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
- 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

Trial Summary

Enrollment Goal
70
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
No
Products
Refametinib (BAY86-9766)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

OncoCare Cancer Centre

Singapore, Singapore, 258499

Status
Completed
 
Locations

Singapore Oncology Consultations

Singapore, Singapore, 228510

Status
Completed
 
Locations

Chi-Mei Medical Center, Liouyine

Tainan, Taiwan, China, 736

Status
Completed
 
Locations

National Taiwan University Hospital

Taipei, Taiwan, China, 100

Status
Completed
 
Locations

National Cheng Kung University Hospital

Tainan, Taiwan, China

Status
Completed
 
Locations

Chang Gung Memorial Hospital Kaohsiung

Kaohsiung, Taiwan, China, 833

Status
Completed
 
Locations

Prince of Wales Hospital

Shatin, Hong Kong, China

Status
Completed
 
Locations

Queen Mary Hospital

Hong Kong, Hong Kong, China

Status
Completed
 
Locations

Samsung Medical Center

Seoul, South Korea, 135-710

Status
Completed
 
Locations

Asan Medical Center

Seoul, South Korea, 138-736

Status
Terminated
 
Locations

Seoul National University Hospital

Seoul, South Korea, 110-744

Status
Completed
 
Locations

National Cancer Center

Goyang-si , South Korea, 410-769

Status
Completed
 
Locations

Kyungpook National University Hospital

Jung-gu, South Korea, 700-721

Status
Completed
 
Locations

Pusan National University Hospital

Busan, South Korea, 602-739

Status
Completed
 
Locations

Yonsei University College of Medicine

Seoul, South Korea, 120-752

Status
Completed
 

Trial Design