Study of Regorafenib After Sorafenib in Patients With Hepatocellular Carcinoma (RESORCE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01774344
First received: January 21, 2013
Last updated: October 30, 2014
Last verified: October 2014
  Purpose

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

Approximately 530 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.


Condition Intervention Phase
Carcinoma, Hepatocellular
Drug: Regorafenib (BAY73-4506)
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Approximately 33 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: Approximately 33 months ] [ Designated as safety issue: No ]
  • Progression free survival (PFS) [ Time Frame: Approximately 33 months ] [ Designated as safety issue: No ]
  • Objective tumor response [ Time Frame: Approximately 33 months ] [ Designated as safety issue: No ]
  • Disease control [ Time Frame: Approximately 33 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 530
Study Start Date: May 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Regorafenib
160 mg orally (p.o.) every day (qd) for 3 weeks of every 4 week cycle (i.e. 3 weeks on, 1 week off) plus BSC (Best Supportive Care)
Drug: Regorafenib (BAY73-4506)
Regorafenib, 40 mg tablets
Placebo Comparator: Placebo
4 matching placebo tablets for 3 weeks of every 4 week cycle (i.e. 3 weeks on, 1 week off) plus BSC
Drug: Placebo
Placebo tablets matching in appearance

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 non-occlusive arterial chemotherapies such as intraarterial chemotherapy or lipiodolization, 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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774344

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

  Show 184 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01774344     History of Changes
Other Study ID Numbers: 15982, 2012-003649-14
Study First Received: January 21, 2013
Last Updated: October 30, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Italy: Agenzia Italiana del Farmaco (AIFA)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
France: Ministry of Health
Singapore: Health Sciences Authority
Brazil: National Health Surveillance Agency
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Japan: Ministry of Health, Labour and Healthcare
Korea: Food and Drug Administration
Russia: FSI Scientific Center of Expertise of Medical Agents
Switzerland: Swissmedic
Taiwan : Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Austria: Federal Office for Safety in Health Care
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Bayer:
Regorafenib
BAY73-4506

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on October 30, 2014