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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01774344
First received: January 21, 2013
Last updated: August 6, 2014
Last verified: August 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

  Hide Study Locations
Locations
United States, California
Recruiting
Los Angeles, California, United States, 90095
Recruiting
Los Angeles, California, United States, 90048
Recruiting
Orange, California, United States, 92868-3201
United States, Colorado
Recruiting
Aurora, Colorado, United States, 80045
United States, District of Columbia
Not yet recruiting
Washington, District of Columbia, United States, 20007-2197
United States, Florida
Recruiting
Gainesville, Florida, United States, 32610-0286
Terminated
Orlando, Florida, United States, 32804
Recruiting
Tampa, Florida, United States, 33606
United States, Illinois
Recruiting
Chicago, Illinois, United States, 60637
United States, Kentucky
Recruiting
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Not yet recruiting
Boston, Massachusetts, United States, 02111
Recruiting
Worcester, Massachusetts, United States, 01655
United States, Michigan
Recruiting
Detroit, Michigan, United States, 48201
United States, Minnesota
Recruiting
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Recruiting
St. Louis, Missouri, United States, 63110
United States, New York
Recruiting
New York, New York, United States, 10029
Terminated
New York, New York, United States, 10016
Recruiting
Rochester, New York, United States, 14642
United States, Oregon
Not yet recruiting
Portland, Oregon, United States, 97239-3011
United States, Pennsylvania
Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Terminated
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Terminated
Dallas, Texas, United States, 75399
United States, Virginia
Recruiting
Richmond, Virginia, United States, 23249
United States, Washington
Not yet recruiting
Seattle, Washington, United States, 98101
Argentina
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Pilar, Buenos Aires, Argentina, B1629ODT
Not yet recruiting
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1181ACH
Australia, New South Wales
Recruiting
Camperdown, New South Wales, Australia, 2050
Not yet recruiting
Liverpool, New South Wales, Australia, 2170
Australia, Victoria
Recruiting
Clayton, Victoria, Australia, 3168
Recruiting
Prahran, Victoria, Australia, 3181
Australia
Recruiting
Box Hill, Australia, 3128
Recruiting
Herston, Australia, 4029
Austria
Recruiting
Linz, Oberösterreich, Austria, 4020
Not yet recruiting
Graz, Steiermark, Austria, 8036
Recruiting
Wien, Austria, 1090
Belgium
Recruiting
Bruxelles - Brussel, Belgium, 1090
Recruiting
La Louviere, Belgium, 7100
Brazil
Not yet recruiting
Salvador, Bahia, Brazil, 41830-492
Not yet recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
Not yet recruiting
Rio de Janeiro, Brazil, 22793-080
Not yet recruiting
Sao Paulo, Brazil, 05403-000
Not yet recruiting
Sao Paulo, Brazil, 01308-050
China, Anhui
Not yet recruiting
Hefei, Anhui, China, 230022
China, Guangdong
Recruiting
Guangzhou, Guangdong, China, 510080
Terminated
Guangzhou, Guangdong, China, 510080
Not yet recruiting
Guangzhou, Guangdong, China, 510060
Recruiting
Guangzhou, Guangdong, China, 510515
China, Guangxi
Recruiting
Nanning, Guangxi, China, 530021
China, Heilongjiang
Recruiting
Harbin, Heilongjiang, China
China, Hubei
Recruiting
Wuhan, Hubei, China, 430030
China, Hunan
Not yet recruiting
Changsha, Hunan, China, 410013
China, Jiangsu
Recruiting
Nanjing, Jiangsu, China, 210003
Not yet recruiting
Suzhou, Jiangsu, China, 215006
China, Liaoning
Recruiting
Dalian, Liaoning, China, 116011
China, Shaanxi
Recruiting
Xi'an, Shaanxi, China, 710032
Recruiting
Xi'an, Shaanxi, China, 710061
Recruiting
Xi'an, Shaanxi, China, 710038
China, Sichuan
Not yet recruiting
Chengdu, Sichuan, China, 610041
China
Recruiting
Beijing, China, 100069
Recruiting
Beijing, China, 100039
Recruiting
Beijing, China, 100142
Not yet recruiting
Beijing, China, 100044
Recruiting
Beijing, China, 100071
Not yet recruiting
Changchun, China, 130012
Not yet recruiting
Chongqing, China, 400038
Recruiting
Fuzhou, China, 350025
Not yet recruiting
Shanghai, China, 200438
Recruiting
Shanghai, China, 200032
Recruiting
Shanghai, China, 200001
Recruiting
Tianjin, China, 300060
Czech Republic
Recruiting
Czech Republic, Czech Republic
Recruiting
Hradec Kralove, Czech Republic, 500 05
Recruiting
Olomouc, Czech Republic, 775 20
France
Recruiting
Angers Cedex 01, France, 49033
Recruiting
Caen, France, F-14033
Recruiting
CLERMONT-FERRAND Cedex 1, France, 63003
Recruiting
Clichy, France, 92110
Recruiting
Creteil, France, 94010
Recruiting
Dijon, France, 21000
Recruiting
La Tronche, France, 38700
Recruiting
Lille, France, 59037
Recruiting
Lyon Cedex, France, 69288
Recruiting
Marseille, France, 13385
Recruiting
Marseille, France, 13005
Recruiting
Montpellier Cedex, France, 34295
Recruiting
Nice, France, 06002
Recruiting
Paris, France, 75012
Recruiting
Paris, France, 75020
Recruiting
Perpignan, France, 66000
Not yet recruiting
Poitiers, France, 86021
Recruiting
Reims Cedex, France, 51092
Recruiting
Rennes Cedex, France, 35062
Recruiting
Toulouse, France, 31059
Recruiting
Vandoeuvre-les-nancy, France, 54500
Recruiting
Villejuif Cedex, France, 94805
Germany
Terminated
Bad Mergentheim, Baden-Württemberg, Germany, 9798
Recruiting
Esslingen, Baden-Württemberg, Germany, 73730
Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Recruiting
München, Bayern, Germany, 81377
Recruiting
Frankfurt, Hessen, Germany, 60590
Recruiting
Hannover, Niedersachsen, Germany, 30625
Recruiting
Aachen, Nordrhein-Westfalen, Germany, 52074
Recruiting
Essen, Nordrhein-Westfalen, Germany, 45136
Recruiting
Köln, Nordrhein-Westfalen, Germany, 50937
Recruiting
Mainz, Rheinland-Pfalz, Germany, 55131
Recruiting
Homburg, Saarland, Germany, 66421
Recruiting
Magdeburg, Sachsen-Anhalt, Germany, 39120
Recruiting
Berlin, Germany, 13353
Recruiting
Hamburg, Germany, 20246
Hungary
Recruiting
Budapest, Hungary, 1097
Recruiting
Debrecen, Hungary, 4032
Recruiting
Kaposvar, Hungary, 7400
Not yet recruiting
Veszprem, Hungary, 8200
Italy
Terminated
Castellana Grotte, Bari, Italy, 70013
Not yet recruiting
San Giovanni Rotondo, Foggia, Italy, 71013
Recruiting
Rozzano, Milano, Italy, 20089
Recruiting
Bergamo, Italy, 24127
Recruiting
Bologna, Italy, 40138
Not yet recruiting
Cagliari, Italy, 09134
Not yet recruiting
Genova, Italy, 16132
Not yet recruiting
Milano, Italy, 20162
Recruiting
Milano, Italy, 20122
Recruiting
Modena, Italy, 41124
Terminated
Napoli, Italy, 80135
Recruiting
Napoli, Italy, 80131
Not yet recruiting
Novara, Italy, 28100
Recruiting
Padova, Italy, 35128
Recruiting
Palermo, Italy, 90127
Not yet recruiting
Palermo, Italy
Recruiting
Pisa, Italy, 56126
Not yet recruiting
Roma, Italy, 00168
Recruiting
Roma, Italy, 00168
Not yet recruiting
Torino, Italy, 10126
Not yet recruiting
Verona, Italy, 37134
Japan
Recruiting
Kashiwa, Chiba, Japan, 277-8577
Not yet recruiting
Iizuka, Fukuoka, Japan, 820-8505
Recruiting
Yokohama, Kanagawa, Japan, 232-0024
Recruiting
Osakasayama, Osaka, Japan, 589-8511
Not yet recruiting
Utsunomiya, Tochigi, Japan, 321-0974
Recruiting
Chiyoda-ku, Tokyo, Japan, 101-0062
Not yet recruiting
Chuo-ku, Tokyo, Japan, 104-0045
Recruiting
Musashino, Tokyo, Japan, 180-8610
Recruiting
Chiba, Japan, 260-8677
Recruiting
Fukuoka, Japan, 810-8563
Not yet recruiting
Kumamoto, Japan, 860-8556
Recruiting
Osaka, Japan, 537-8511
Korea, Republic of
Recruiting
Busan, Busan Gwang''yeogsi, Korea, Republic of, 602-739
Recruiting
Daegu, Korea, Republic of, 700-721
Recruiting
Seoul, Korea, Republic of, 135-710
Recruiting
Seoul, Korea, Republic of, 110-744
Netherlands
Not yet recruiting
Amsterdam, Netherlands, 1105 AZ
Not yet recruiting
Leiden, Netherlands, 2333 ZA
Terminated
Rotterdam, Netherlands, 3015 CE
Russian Federation
Recruiting
Barnaul, Russian Federation, 656052
Recruiting
Moscow, Russian Federation, 115478
Recruiting
Moscow, Russian Federation, 119992
Terminated
Moscow, Russian Federation, 115478
Terminated
St. Petersburg, Russian Federation, 195 067
Singapore
Recruiting
Singapore, Singapore, 258500
Recruiting
Singapore, Singapore, 119228
Spain
Recruiting
Santiago de Compostela, A Coruña, Spain, 15706
Recruiting
Oviedo, Asturias, Spain, 33006
Recruiting
Alicante, Spain, 03010
Recruiting
Barcelona, Spain, 08036
Recruiting
Barcelona, Spain, 08035
Recruiting
Córdoba, Spain, 14004
Not yet recruiting
Madrid, Spain, 28034
Recruiting
Madrid, Spain, 28007
Recruiting
Madrid, Spain, 28050
Recruiting
Madrid, Spain, 28041
Recruiting
Valladolid, Spain, 47012
Recruiting
Zaragoza, Spain, 50009
Switzerland
Terminated
St. Gallen, Sankt Gallen, Switzerland, 9007
Not yet recruiting
Viganello, Ticino, Switzerland, 6962
Recruiting
Bern, Switzerland, 3010
Taiwan
Recruiting
Kaohsiung, Taiwan, 833
Recruiting
Taipei, Taiwan, 10016
Recruiting
Taipei, Taiwan, 11217
Recruiting
Taoyuan, Taiwan, 333
United Kingdom
Recruiting
Birmingham, West Midlands, United Kingdom, B15 2TT
Recruiting
Leeds, West Yorkshire, United Kingdom, LS9 7TF
Recruiting
Bristol, United Kingdom, BS2 8ED
Recruiting
London, United Kingdom, SE5 9RS
Not yet recruiting
London, United Kingdom, W12 0HS
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: August 6, 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
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
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2014