Study of Regorafenib After Sorafenib in Patients With Hepatocellular Carcinoma



Status:Active, not recruiting
Conditions:Liver Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/17/2019
Start Date:May 14, 2013
End Date:December 31, 2019

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

This clinical study evaluates the efficacy and safety of regorafenib in patients with
advanced liver cancer who have progressed on sorafenib treatment.

Approximately 560 patients who meet the entry criteria will be randomly assigned in a 2:1
ratio to regorafenib or placebo (1/3 chance to receive placebo).

Primary endpoint of the study is overall survival.

Regorafenib BAY73-4506

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, 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 10 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 of intrahepatic tumor lesions (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. Note: patients who received sole intrahepatic intraarterial
chemotherapy, without lipiodol or embolizing agents are not eligible.

- 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 m^2 according to the Modification of
diet in renal disease study equation.

- 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
toxicity.

- 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
treatment).

- 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 required.

- 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.
We found this trial at
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