Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01774344
Registration number
NCT01774344
Ethics application status
Date submitted
21/01/2013
Date registered
24/01/2013
Date last updated
20/08/2020
Titles & IDs
Public title
Study of Regorafenib After Sorafenib in Patients With Hepatocellular Carcinoma
Query!
Scientific title
A Randomized, Double Blind, Placebo Controlled, Multicenter Phase III Study of Regorafenib in Patients With Hepatocellular Carcinoma (HCC) After Sorafenib
Query!
Secondary ID [1]
0
0
2012-003649-14
Query!
Secondary ID [2]
0
0
15982
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
RESORCE
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Hepatocellular
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Non melanoma skin cancer
Query!
Cancer
0
0
0
0
Query!
Kidney
Query!
Cancer
0
0
0
0
Query!
Liver
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Regorafenib (Stivarga, BAY73-4506)
Treatment: Drugs - Placebo
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)
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
Treatment: Drugs: Regorafenib (Stivarga, BAY73-4506)
Regorafenib, 40 mg tablets
Treatment: Drugs: Placebo
Placebo tablets matching in appearance
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Overall Survival (OS)
Query!
Assessment method [1]
0
0
Overall Survival (OS) was defined as the time from date of randomization (Day 1) to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
Query!
Timepoint [1]
0
0
From randomization (Day 1) of the first subject until 419 days later
Query!
Secondary outcome [1]
0
0
Time to Progression (TTP)
Query!
Assessment method [1]
0
0
TTP was the time (days) from randomization to radiological or clinical disease progression assessed by independent radiological review. Median and 95% confidence interval were reported for the modified response evaluation criteria in solid tumors (mRECIST) and response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) analysis sets. Subjects still alive at the time of analysis were censored at their last date of last contact.
Query!
Timepoint [1]
0
0
From date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks) (approximately 33 months)
Query!
Secondary outcome [2]
0
0
Progression Free Survival (PFS)
Query!
Assessment method [2]
0
0
Progression Free Survival (PFS) was defined as the time (days) from date of randomization to date of disease progression (radiological or clinical) or death due to any cause, if death occurs before progression was documented. Death in the absence of progression was a PFS event only if it occurred within the 12+1 weeks for subjects who discontinued treatment prior to cycle 8 and 24+2 weeks for subjects who discontinued treatment after to cycle 8 of the last evaluable tumor assessment; PFS were censored at the date of the last evaluable tumor assessment, if it occurred later. Median and 95% confidence interval 95% were reported for the mRECIST and RECIST 1.1 analysis sets. Subjects still alive at the time of analysis were censored at their last date of last contact.
Query!
Timepoint [2]
0
0
From date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks)
Query!
Secondary outcome [3]
0
0
Objective Tumor Response Rate (ORR)
Query!
Assessment method [3]
0
0
Objective tumor response rate (ORR) was defined as the percentage of subjects whose best tumor response CR or Partial Response (PR) observed during trial period assessed according to the mRECIST criteria and RECIST 1.1. CR= Disappearance of all clinical and radiological evidence of tumor (both target and non-target). Any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non target lesions and no appearance of new lesions. Subjects prematurely discontinuing without an assessment were to be considered non-responders for the analysis.
Query!
Timepoint [3]
0
0
From date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks) (approximately 33 months)
Query!
Secondary outcome [4]
0
0
Disease Control Rate (DCR)
Query!
Assessment method [4]
0
0
Disease control rate (DCR) was defined as the percentage of subjects whose best response was CR (CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).), PR (PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.), or stable disease (SD) (SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.) according to RECIST and RECIST 1.1 criteria. SD had to be maintained for at least 6 weeks from the first demonstration of that rating.
Query!
Timepoint [4]
0
0
From date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks) (approximately 33 months)
Query!
Eligibility
Key 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 .
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
14/05/2013
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
5/07/2019
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
573
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Query!
Recruitment hospital [1]
0
0
- Camperdown
Query!
Recruitment hospital [2]
0
0
- Liverpool
Query!
Recruitment hospital [3]
0
0
- Herston
Query!
Recruitment hospital [4]
0
0
- Clayton
Query!
Recruitment hospital [5]
0
0
- Box Hill
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
2170 - Liverpool
Query!
Recruitment postcode(s) [3]
0
0
4029 - Herston
Query!
Recruitment postcode(s) [4]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [5]
0
0
3128 - Box Hill
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
District of Columbia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Illinois
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Kentucky
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Massachusetts
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Minnesota
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Missouri
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
New York
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Pennsylvania
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Virginia
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Washington
Query!
Country [14]
0
0
Argentina
Query!
State/province [14]
0
0
Buenos Aires
Query!
Country [15]
0
0
Austria
Query!
State/province [15]
0
0
Oberösterreich
Query!
Country [16]
0
0
Austria
Query!
State/province [16]
0
0
Steiermark
Query!
Country [17]
0
0
Austria
Query!
State/province [17]
0
0
Wien
Query!
Country [18]
0
0
Belgium
Query!
State/province [18]
0
0
Bruxelles - Brussel
Query!
Country [19]
0
0
Belgium
Query!
State/province [19]
0
0
La Louviere
Query!
Country [20]
0
0
Brazil
Query!
State/province [20]
0
0
Bahia
Query!
Country [21]
0
0
Brazil
Query!
State/province [21]
0
0
Sao Paulo
Query!
Country [22]
0
0
China
Query!
State/province [22]
0
0
Anhui
Query!
Country [23]
0
0
China
Query!
State/province [23]
0
0
Fujian
Query!
Country [24]
0
0
China
Query!
State/province [24]
0
0
Guangdong
Query!
Country [25]
0
0
China
Query!
State/province [25]
0
0
Guangxi
Query!
Country [26]
0
0
China
Query!
State/province [26]
0
0
Heilongjiang
Query!
Country [27]
0
0
China
Query!
State/province [27]
0
0
Hubei
Query!
Country [28]
0
0
China
Query!
State/province [28]
0
0
Hunan
Query!
Country [29]
0
0
China
Query!
State/province [29]
0
0
Jiangsu
Query!
Country [30]
0
0
China
Query!
State/province [30]
0
0
Liaoning
Query!
Country [31]
0
0
China
Query!
State/province [31]
0
0
Shaanxi
Query!
Country [32]
0
0
China
Query!
State/province [32]
0
0
Sichuan
Query!
Country [33]
0
0
China
Query!
State/province [33]
0
0
Beijing
Query!
Country [34]
0
0
China
Query!
State/province [34]
0
0
Chongqing
Query!
Country [35]
0
0
China
Query!
State/province [35]
0
0
Shanghai
Query!
Country [36]
0
0
China
Query!
State/province [36]
0
0
Tianjin
Query!
Country [37]
0
0
Czechia
Query!
State/province [37]
0
0
Hradec Kralove
Query!
Country [38]
0
0
Czechia
Query!
State/province [38]
0
0
Olomouc
Query!
Country [39]
0
0
Czechia
Query!
State/province [39]
0
0
Praha 2
Query!
Country [40]
0
0
France
Query!
State/province [40]
0
0
Angers
Query!
Country [41]
0
0
France
Query!
State/province [41]
0
0
Caen
Query!
Country [42]
0
0
France
Query!
State/province [42]
0
0
Clichy
Query!
Country [43]
0
0
France
Query!
State/province [43]
0
0
Creteil
Query!
Country [44]
0
0
France
Query!
State/province [44]
0
0
Dijon
Query!
Country [45]
0
0
France
Query!
State/province [45]
0
0
La Tronche
Query!
Country [46]
0
0
France
Query!
State/province [46]
0
0
Lille
Query!
Country [47]
0
0
France
Query!
State/province [47]
0
0
Lyon
Query!
Country [48]
0
0
France
Query!
State/province [48]
0
0
Marseille
Query!
Country [49]
0
0
France
Query!
State/province [49]
0
0
Montpellier Cedex
Query!
Country [50]
0
0
France
Query!
State/province [50]
0
0
Nice Cedex 3
Query!
Country [51]
0
0
France
Query!
State/province [51]
0
0
Paris
Query!
Country [52]
0
0
France
Query!
State/province [52]
0
0
Perpignan
Query!
Country [53]
0
0
France
Query!
State/province [53]
0
0
Reims Cedex
Query!
Country [54]
0
0
France
Query!
State/province [54]
0
0
Rennes Cedex
Query!
Country [55]
0
0
France
Query!
State/province [55]
0
0
Toulouse
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
Vandoeuvre les Nancy
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Villejuif Cedex
Query!
Country [58]
0
0
Germany
Query!
State/province [58]
0
0
Baden-Württemberg
Query!
Country [59]
0
0
Germany
Query!
State/province [59]
0
0
Bayern
Query!
Country [60]
0
0
Germany
Query!
State/province [60]
0
0
Hessen
Query!
Country [61]
0
0
Germany
Query!
State/province [61]
0
0
Niedersachsen
Query!
Country [62]
0
0
Germany
Query!
State/province [62]
0
0
Nordrhein-Westfalen
Query!
Country [63]
0
0
Germany
Query!
State/province [63]
0
0
Rheinland-Pfalz
Query!
Country [64]
0
0
Germany
Query!
State/province [64]
0
0
Sachsen-Anhalt
Query!
Country [65]
0
0
Germany
Query!
State/province [65]
0
0
Berlin
Query!
Country [66]
0
0
Germany
Query!
State/province [66]
0
0
Hamburg
Query!
Country [67]
0
0
Hungary
Query!
State/province [67]
0
0
Budapest
Query!
Country [68]
0
0
Hungary
Query!
State/province [68]
0
0
Debrecen
Query!
Country [69]
0
0
Hungary
Query!
State/province [69]
0
0
Kaposvar
Query!
Country [70]
0
0
Italy
Query!
State/province [70]
0
0
Campania
Query!
Country [71]
0
0
Italy
Query!
State/province [71]
0
0
Emilia-Romagna
Query!
Country [72]
0
0
Italy
Query!
State/province [72]
0
0
Lazio
Query!
Country [73]
0
0
Italy
Query!
State/province [73]
0
0
Liguria
Query!
Country [74]
0
0
Italy
Query!
State/province [74]
0
0
Lombardia
Query!
Country [75]
0
0
Italy
Query!
State/province [75]
0
0
Piemonte
Query!
Country [76]
0
0
Italy
Query!
State/province [76]
0
0
Puglia
Query!
Country [77]
0
0
Italy
Query!
State/province [77]
0
0
Sardegna
Query!
Country [78]
0
0
Italy
Query!
State/province [78]
0
0
Toscana
Query!
Country [79]
0
0
Italy
Query!
State/province [79]
0
0
Veneto
Query!
Country [80]
0
0
Japan
Query!
State/province [80]
0
0
Chiba
Query!
Country [81]
0
0
Japan
Query!
State/province [81]
0
0
Fukuoka
Query!
Country [82]
0
0
Japan
Query!
State/province [82]
0
0
Kanagawa
Query!
Country [83]
0
0
Japan
Query!
State/province [83]
0
0
Kumamoto
Query!
Country [84]
0
0
Japan
Query!
State/province [84]
0
0
Osaka
Query!
Country [85]
0
0
Japan
Query!
State/province [85]
0
0
Tochigi
Query!
Country [86]
0
0
Japan
Query!
State/province [86]
0
0
Tokyo
Query!
Country [87]
0
0
Korea, Republic of
Query!
State/province [87]
0
0
Busan Gwang''yeogsi
Query!
Country [88]
0
0
Korea, Republic of
Query!
State/province [88]
0
0
Daegu
Query!
Country [89]
0
0
Korea, Republic of
Query!
State/province [89]
0
0
Seoul
Query!
Country [90]
0
0
Netherlands
Query!
State/province [90]
0
0
Amsterdam
Query!
Country [91]
0
0
Netherlands
Query!
State/province [91]
0
0
Leiden
Query!
Country [92]
0
0
Russian Federation
Query!
State/province [92]
0
0
Barnaul
Query!
Country [93]
0
0
Russian Federation
Query!
State/province [93]
0
0
Moscow
Query!
Country [94]
0
0
Singapore
Query!
State/province [94]
0
0
Singapore
Query!
Country [95]
0
0
Spain
Query!
State/province [95]
0
0
Asturias
Query!
Country [96]
0
0
Spain
Query!
State/province [96]
0
0
Alicante
Query!
Country [97]
0
0
Spain
Query!
State/province [97]
0
0
Barcelona
Query!
Country [98]
0
0
Spain
Query!
State/province [98]
0
0
Córdoba
Query!
Country [99]
0
0
Spain
Query!
State/province [99]
0
0
Madrid
Query!
Country [100]
0
0
Spain
Query!
State/province [100]
0
0
Zaragoza
Query!
Country [101]
0
0
Switzerland
Query!
State/province [101]
0
0
Ticino
Query!
Country [102]
0
0
Switzerland
Query!
State/province [102]
0
0
Bern
Query!
Country [103]
0
0
Taiwan
Query!
State/province [103]
0
0
Kaohsiung
Query!
Country [104]
0
0
Taiwan
Query!
State/province [104]
0
0
Taipei
Query!
Country [105]
0
0
Taiwan
Query!
State/province [105]
0
0
Taoyuan
Query!
Country [106]
0
0
United Kingdom
Query!
State/province [106]
0
0
West Midlands
Query!
Country [107]
0
0
United Kingdom
Query!
State/province [107]
0
0
West Yorkshire
Query!
Country [108]
0
0
United Kingdom
Query!
State/province [108]
0
0
Bristol
Query!
Country [109]
0
0
United Kingdom
Query!
State/province [109]
0
0
London
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Bayer
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The objective of this study was to evaluate efficacy and safety of regorafenib in patients
with advanced liver cancer who had progressed after sorafenib treatment. Patients were
treated with regorafenib or placebo using a 2:1 randomization scheme.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01774344
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bayer Study Director
Query!
Address
0
0
Bayer
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01774344
Download to PDF