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A Randomized, Double Blind, Placebo Controlled, Multicenter Phase III Study of Regorafenib in Patients With Hepatocellular Carcinoma (HCC) After Sorafenib

Phase 3
18 Years
Open (Enrolling)
Carcinoma, Hepatocellular

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Trial Information

A Randomized, Double Blind, Placebo Controlled, Multicenter Phase III Study of Regorafenib in Patients With Hepatocellular Carcinoma (HCC) After Sorafenib

Inclusion Criteria:

- Histological or cytological confirmation of HCC (hepatocellular carcinoma) or
non-invasive diagnosis of HCC as per American Association for the Study of Liver
Diseases criteria in patients with a confirmed diagnosis of cirrhosis

- Barcelona Clinic Liver Cancer stage Category B or C that cannot benefit from
treatments of established efficacy with higher priority such as resection, liver
transplantation, local ablation, chemoembolization or systemic sorafenib.

- Failure to prior treatment with sorafenib (defined as documented radiological
progression according to the radiology charter). Randomization needs to be performed
within 8 weeks after the last treatment with sorafenib.

- Tolerability of prior treatment with sorafenib defined as not less than 20 days at a
minimum daily dose of 400 mg QD within the last 28 days prior to withdrawal.

- Liver function status Child-Pugh Class A. Child Pugh status should be calculated
based on clinical findings and laboratory results during the screening period.

- Local or loco-regional therapy (e.g. surgery, radiation therapy, hepatic arterial
embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol
injection, or cryoablation) must have been completed >/= 4 weeks before first dose of
study medication.

- Eastern Cooperative Oncology Group Performance Status of 0 or 1.

- Adequate bone marrow, liver and renal function as assessed by the following
laboratory tests conducted within 7 days before randomization.

- Glomerular filtration rate >/= 30 ml/min/1.73 m2 according to the Modification of
diet in renal disease abbreviated formula.

- At least one uni-dimensional measurable lesion by computed tomography (CT) scan or
magnetic resonance imaging (MRI) according to RECIST (RECIST version 1.1), and
modified RECIST for HCC. Tumor lesions situated in a previously irradiated area, or
in an area subjected to other loco-regional therapy, may be considered measurable if
there has been demonstrated progression in the lesion.

- Life expectancy of at least 3 months.

- Women of childbearing potential and men must agree to use adequate contraception .

Exclusion Criteria:

- Sorafenib treatment within 2 weeks of randomization.

- Prior systemic treatment for HCC, except sorafenib.

- Permanent discontinuation of prior sorafenib therapy due to sorafenib related

- Known history or symptomatic metastatic brain or meningeal tumors (head CT or MRI at
screening to confirm the absence of central nervous system [CNS] disease if patient
has symptoms suggestive or consistent with CNS disease).

- Uncontrolled hypertension (systolic blood pressure [BP] > 150 mmHg or diastolic
pressure > 90 mmHg despite optimal medical management).

- Uncontrolled ascites (defined as not easily controlled with diuretic or paracentesis

- Ongoing infection > Grade 2 according to NCI-CTCAE (National Cancer Institute -
Common Terminology Criteria for Adverse Events) v. 4.0. Hepatitis B is allowed if no
active replication is present. Hepatitis C is allowed if no antiviral treatment is

- Clinically significant bleeding NCI-CTCAE version 4.0 Grade 3 or higher within 30
days before randomization.

- Arterial or venous thrombotic or embolic events such as cerebrovascular accident
(including transient ischemic attacks), deep vein thrombosis or pulmonary embolism
within 6 months before the start of study medication.

- Patients unable to swallow oral medications.

- Interstitial lung disease with ongoing signs and symptoms at the time of screening.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

Approximately 33 months

Safety Issue:


Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:



Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

May 2013

Completion Date:

October 2016

Related Keywords:

  • Carcinoma, Hepatocellular
  • Regorafenib
  • BAY73-4506
  • Carcinoma
  • Carcinoma, Hepatocellular



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