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A Phase II Trial of BAY86-9766 Plus Sorafenib as First Line Systemic Treatment for Hepatocellular Carcinoma (HCC)

Phase 2
18 Years
Open (Enrolling)
Carcinoma, Hepatocellular

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Trial Information

A Phase II Trial of BAY86-9766 Plus Sorafenib as First Line Systemic Treatment for Hepatocellular Carcinoma (HCC)

Inclusion Criteria:

- Male or Female age >/= 18 years of age

- Life expectancy >/= 12 weeks

- Histologically or cytologically confirmed diagnosis of HCC, unresectable advanced or

- 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

- Major surgery within 4 weeks of start of study

- Concomitant use of strong inhibitors and strong inducers of CYP3A4

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease Control Rate (DCR)

Outcome Time Frame:

From first dose of combination treatment until last tumor evaluation

Safety Issue:


Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:



Korea: Food and Drug Administration

Study ID:




Start Date:

December 2010

Completion Date:

December 2013

Related Keywords:

  • Carcinoma, Hepatocellular
  • Hepatocellular carcinoma (HCC)
  • MEK inhibitor
  • Sorafenib
  • Disease control rate (DCR)
  • Safety
  • Carcinoma
  • Carcinoma, Hepatocellular