Trial Condition(s):
Carcinoma, Hepatocellular
Study of regorafenib after sorafenib in patients with hepatocellular carcinoma (RESORCE)
Bayer Identifier:
15982
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
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 .
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Mainz, Germany, 55131 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Magdeburg, Germany, 39120 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Essen, Germany, 45136 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamburg, Germany, 20246 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Richmond, United States, 23249 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New York, United States, 10029 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Louisville, United States, 40202 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site München, Germany, 81377 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS, France, 75651 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vandoeuvre les Nancy, France, 54500 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LILLE, France, 59037 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site NICE CEDEX 3, France, 06202 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oviedo, Spain, 33011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20089 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bologna, Italy, 40138 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Novara, Italy, 28100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Roma, Italy, 00168 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pisa, Italy, 56126 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Napoli, Italy, 80131 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Modena, Italy, 41124 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Foggia, Italy, 71013 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bergamo, Italy, 24127 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Padova, Italy, 35128 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Frankfurt, Germany, 60590 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Minneapolis, United States, 55455 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gainesville, United States, 32610-0286 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Louis, United States, 63110 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rochester, United States, 14642 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site CLICHY, France, 92110 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Angers, France, 49100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site CRETEIL, France, 94010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LYON, France, 69004 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08036 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taipei, Taiwan, China, 10016 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taipei, Taiwan, China, 11217 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taoyuan, Taiwan, China, 333423 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kaohsiung City, Taiwan, China, 83301 | Status Completed | Contact Us: E-mail: c[email protected] Phone: Not Available |
Locations Investigative Site LA LOUVIERE, Belgium, 7100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1090 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Busan, South Korea, 49241 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 06351 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Daegu, South Korea, 700-721 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 110-744 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Los Angeles, United States, 90095 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Washington, United States, 20007-2197 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site RENNES CEDEX, France, 35062 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Salvador, Brazil, 41950-610 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, United Kingdom, SE5 9RS | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bristol, United Kingdom, BS2 8ED | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Birmingham, United Kingdom, B15 2WB | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Leeds, United Kingdom, LS9 7TF | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Aurora, United States, 80045 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Heidelberg, Germany, 69120 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 13353 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08035 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS, France, 75020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site CAEN, France, F-14033 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site VILLEJUIF CEDEX, France, 94805 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Singapore, Singapore, 119228 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Aachen, Germany, 52074 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cagliari, Italy, 09134 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20122 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Genova, Italy, 16132 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Córdoba, Spain, 14004 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Alicante, Spain, 03010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bern, Switzerland, 3010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Los Angeles, United States, 90048 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pittsburgh, United States, 15232 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Worcester, United States, 01655 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site TOULOUSE, France, 31059 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site DIJON, France, 21000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MONTPELLIER CEDEX, France, 34295 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osakasayama-shi, Japan, 589-8511 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kashiwa-shi, Japan, 277-8577 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chuo-ku, Japan, 104-0045 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chiba-shi, Japan, 260-8677 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Musashino-shi, Japan, 180-8610 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osaka-shi, Japan, 541-8567 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fukuoka-shi, Japan, 810-8563 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28007 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site AMSTERDAM, Netherlands, 1105 AZ | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LEIDEN, Netherlands, 2333 ZA | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Budapest, Hungary, 1097 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Debrecen, Hungary, 4032 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sao Paulo, Brazil, 05403-000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barnaul, Russia, 656045 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 119991 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MARSEILLE, France, 13005 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kaposvar, Hungary, 7400 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Orange, United States, 92868-3201 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chicago, United States, 60637 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pilar, Argentina, B1629ODT | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bellinzona, Switzerland, 6500 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nanjing, China, 210002 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hradec Kralove, Czech Republic, 500 05 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Olomouc, Czech Republic, 775 20 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zaragoza, Spain, 50009 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hannover, Germany, 30625 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Herston, Australia, 4029 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Köln, Germany, 50937 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28050 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 2, Czech Republic, 128 08 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Camperdown, Australia, 2050 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Torino, Italy, 10126 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Liverpool, Australia, 2170 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28041 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Clayton, Australia, 3168 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BOX HILL, Australia, 3128 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shanghai, China, 200032 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Xi'an, China, 710061 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dalian, China, 116011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site shanghai, China, 200001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shanghai, China, 201805 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Xi'an, China, 710032 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100142 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hefei, China, 230022 | Status Suspended | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100071 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tianjin, China, 300060 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nanning, China, 530021 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Changsha, China, 410013 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Harbin, China, 150081 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Xi'an, China, 710038 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chengdu, China, 610041 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fuzhou, China, 350025 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Guangzhou, China, 510080 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chongqing, China, 400038 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seattle, United States, 98101 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tampa, United States, 33606 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Guangzhou, China, 510515 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100039 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wuhan, China, 430030 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Suzhou, China, 215006 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100069 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Linz, Austria, 4020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wien, Austria, 1090 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Graz, Austria, 8036 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Guangzhou, China, 510060 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site REIMS CEDEX, France, 51092 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PERPIGNAN, France, 66000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LA TRONCHE, France, 38700 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Iizuka-shi, Japan, 820-8505 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Yokohama-shi, Japan, 232-0024 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kumamoto-shi, Japan, 860-8556 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chiyoda-ku, Japan, 101-0062 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, United Kingdom, W12 0HS | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Utsunomiya-shi, Japan, 321-0974 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A randomized, double blind, placebo controlled, multicenter phase III study of regorafenib in patients with hepatocellular carcinoma (HCC) after sorafenib
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Overall Survival (OS)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.Timeframe: From randomization (Day 1) of the first subject until 419 days later
Secondary Outcome
- Time to Progression (TTP)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.Timeframe: 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)
- Progression Free Survival (PFS)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.Timeframe: 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)
- Objective Tumor Response Rate (ORR)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.Timeframe: 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)
- Disease Control Rate (DCR)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.Timeframe: 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)
Additional Information
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