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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
N/A
Open (Enrolling)
Both
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
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.

Type of Study:

Interventional

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:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

15982

NCT ID:

NCT01774344

Start Date:

May 2013

Completion Date:

October 2016

Related Keywords:

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

Name

Location

Hinsdale, Illinois  60521
Alexandria, Minnesota  56308
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Philadelphia, Pennsylvania  19104
Austin, Texas  78705
Flint, Michigan  48532
Louisville, Kentucky  40207
McLean, Virginia  22101
Denver, Colorado  
Boston, Massachusetts  
Eugene, Oregon  
Washington, District of Columbia