Trial record 1 of 1 for:    bayer 15982
Previous Study | Return to List | Next Study

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01774344
First received: January 21, 2013
Last updated: May 26, 2016
Last verified: May 2016
  Purpose

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.


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 ]

Enrollment: 573
Study Start Date: May 2013
Estimated Study Completion Date: October 2016
Primary Completion Date: February 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

Detailed Description:
Regorafenib BAY73-4506
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 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 m2 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.
  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

  Hide Study Locations
Locations
United States, California
Los Angeles, California, United States, 90048
Los Angeles, California, United States, 90095
Orange, California, United States, 92868-3201
United States, Colorado
Aurora, Colorado, United States, 80045
United States, District of Columbia
Washington, District of Columbia, United States, 20007-2197
United States, Florida
Gainesville, Florida, United States, 32610-0286
Orlando, Florida, United States, 32804
Tampa, Florida, United States, 33606
United States, Illinois
Chicago, Illinois, United States, 60637
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Boston, Massachusetts, United States, 02111
Worcester, Massachusetts, United States, 01655
United States, Michigan
Detroit, Michigan, United States, 48201
United States, Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
St. Louis, Missouri, United States, 63110
United States, New York
New York, New York, United States, 10016
New York, New York, United States, 10029
Rochester, New York, United States, 14642
United States, Oregon
Portland, Oregon, United States, 97239-3011
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Dallas, Texas, United States, 75399
United States, Virginia
Richmond, Virginia, United States, 23249
United States, Washington
Seattle, Washington, United States, 98101
Argentina
Pilar, Buenos Aires, Argentina, B1629ODT
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1181ACH
Australia, New South Wales
Camperdown, New South Wales, Australia, 2050
Liverpool, New South Wales, Australia, 2170
Australia, Victoria
Clayton, Victoria, Australia, 3168
Prahran, Victoria, Australia, 3181
Australia
Box Hill, Australia, 3128
Herston, Australia, 4029
Austria
Linz, Oberösterreich, Austria, 4020
Graz, Steiermark, Austria, 8036
Wien, Austria, 1090
Belgium
Bruxelles - Brussel, Belgium, 1090
La Louviere, Belgium, 7100
Brazil
Salvador, Bahia, Brazil, 41830-492
Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
Rio de Janeiro, Brazil, 22793-080
Sao Paulo, Brazil, 05403-000
Sao Paulo, Brazil, 01308-050
China, Anhui
Hefei, Anhui, China, 230022
China, Fujian
Fuzhou, Fujian, China, 350025
China, Guangdong
Guangzhou, Guangdong, China, 510060
Guangzhou, Guangdong, China, 510080
Guangzhou, Guangdong, China, 510515
China, Guangxi
Nanning, Guangxi, China, 530021
China, Heilongjiang
Harbin, Heilongjiang, China, 150056
China, Hubei
Wuhan, Hubei, China, 430030
China, Hunan
Changsha, Hunan, China, 410013
China, Jiangsu
Nanjing, Jiangsu, China, 210003
Suzhou, Jiangsu, China, 215006
China, Liaoning
Dalian, Liaoning, China, 116011
China, Shaanxi
Xi'an, Shaanxi, China, 710032
Xi'an, Shaanxi, China, 710038
Xi'an, Shaanxi, China, 710061
China, Sichuan
Chengdu, Sichuan, China, 610041
China
Beijing, China, 100142
Beijing, China, 100044
Beijing, China, 100069
Beijing, China, 100071
Beijing, China, 100039
Changchun, China, 130012
Chongqing, China, 400038
Shanghai, China, 200001
Shanghai, China, 200032
Shanghai, China, 200438
Tianjin, China, 300060
Czech Republic
Hradec Kralove, Czech Republic, 500 05
Olomouc, Czech Republic, 775 20
Praha 2, Czech Republic, 128 08
France
Angers Cedex 01, France, 49033
Caen, France, F-14033
CLERMONT-FERRAND Cedex 1, France, 63003
Clichy, France, 92110
Creteil, France, 94010
Dijon, France, 21000
La Tronche, France, 38700
Lille, France, 59037
Lyon Cedex, France, 69288
Marseille, France, 13005
Montpellier Cedex, France, 34295
Nice Cedex 3, France, 06202
Paris, France, 75020
Paris, France, 75651
Perpignan, France, 66000
Poitiers, France, 86021
Reims Cedex, France, 51092
Rennes Cedex, France, 35062
Toulouse, France, 31059
Vandoeuvre-les-nancy, France, 54500
Villejuif Cedex, France, 94805
Germany
Bad Mergentheim, Baden-Württemberg, Germany, 9798
Esslingen, Baden-Württemberg, Germany, 73730
Heidelberg, Baden-Württemberg, Germany, 69120
München, Bayern, Germany, 81377
Frankfurt, Hessen, Germany, 60590
Hannover, Niedersachsen, Germany, 30625
Aachen, Nordrhein-Westfalen, Germany, 52074
Essen, Nordrhein-Westfalen, Germany, 45136
Köln, Nordrhein-Westfalen, Germany, 50937
Mainz, Rheinland-Pfalz, Germany, 55131
Homburg, Saarland, Germany, 66421
Magdeburg, Sachsen-Anhalt, Germany, 39120
Berlin, Germany, 13353
Hamburg, Germany, 20246
Hungary
Budapest, Hungary, 1097
Debrecen, Hungary, 4032
Kaposvar, Hungary, 7400
Veszprem, Hungary, 8200
Italy
Castellana Grotte, Bari, Italy, 70013
San Giovanni Rotondo, Foggia, Italy, 71013
Rozzano, Milano, Italy, 20089
Bergamo, Italy, 24127
Bologna, Italy, 40138
Cagliari, Italy, 09134
Genova, Italy, 16132
Milano, Italy, 20162
Milano, Italy, 20122
Modena, Italy, 41124
Napoli, Italy, 80131
Novara, Italy, 28100
Padova, Italy, 35128
Palermo, Italy, 90127
Palermo, Italy
Pisa, Italy, 56126
Roma, Italy, 00168
Torino, Italy, 10126
Verona, Italy, 37134
Japan
Kashiwa, Chiba, Japan, 277-8577
Iizuka, Fukuoka, Japan, 820-8505
Yokohama, Kanagawa, Japan, 232-0024
Osakasayama, Osaka, Japan, 589-8511
Utsunomiya, Tochigi, Japan, 321-0974
Chiyoda-ku, Tokyo, Japan, 101-0062
Chuo-ku, Tokyo, Japan, 104-0045
Musashino, Tokyo, Japan, 180-8610
Chiba, Japan, 260-8677
Fukuoka, Japan, 810-8563
Kumamoto, Japan, 860-8556
Osaka, Japan, 537-8511
Korea, Republic of
Busan, Busan Gwang''yeogsi, Korea, Republic of, 602-739
Daegu, Korea, Republic of, 700-721
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 135-710
Netherlands
Amsterdam, Netherlands, 1105 AZ
Leiden, Netherlands, 2333 ZA
Rotterdam, Netherlands, 3015 CE
Russian Federation
Barnaul, Russian Federation, 656052
Moscow, Russian Federation, 115478
Moscow, Russian Federation, 119991
St. Petersburg, Russian Federation, 195067
Singapore
Singapore, Singapore, 119228
Singapore, Singapore, 258500
Spain
Santiago de Compostela, A Coruña, Spain, 15706
Oviedo, Asturias, Spain, 33011
Alicante, Spain, 03010
Barcelona, Spain, 08036
Barcelona, Spain, 08035
Córdoba, Spain, 14004
Madrid, Spain, 28050
Madrid, Spain, 28007
Madrid, Spain, 28034
Madrid, Spain, 28041
Valladolid, Spain, 47012
Zaragoza, Spain, 50009
Switzerland
St. Gallen, Sankt Gallen, Switzerland, 9007
Viganello, Ticino, Switzerland, 6962
Bern, Switzerland, 3010
Taiwan
Kaohsiung, Taiwan, 833
Taipei, Taiwan, 11217
Taipei, Taiwan, 10016
Taoyuan, Taiwan, 333
United Kingdom
Birmingham, West Midlands, United Kingdom, B15 2TT
Leeds, West Yorkshire, United Kingdom, LS9 7TF
Bristol, United Kingdom, BS2 8ED
London, United Kingdom, W12 0HS
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
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: May 26, 2016
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
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2016