Status:
COMPLETED
Assessing BAY86-9766 Plus Sorafenib for the Treatment of Liver Cancer.
Lead Sponsor:
Bayer
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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. E...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01204177
Start Date
December 1 2010
End Date
August 1 2013
Last Update
September 6 2013
Active Locations (15)
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1
Shatin, New Territories, Hong Kong
2
Hong Kong, Hong Kong
3
Singapore, Singapore, 228510
4
Singapore, Singapore, 258499