check_circleStudy Completed
Carcinoma, Hepatocellular
Bayer Identifier:
16728
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Refametinib in combination with sorafenib in RAS mutant Hepatocellular Carcinoma (HCC)
Trial purpose
This is a study to investigate the potential clinical benefit of refametinib when given in combination with sorafenib as first line treatment in patients with unresectable or metastatic HCC carrying a RAS mutation. The study will be conducted in 2 stages. Approximately 95 patients (15 at Stage 1/ 80 at Stage 2) will be accrued to this study to receive treatment. Stage 2 of the trial will only be conducted if at least 5 out of 15 patients at Stage 1 show at least partial response according to an objective criteria to evaluate tumor size based on contrast enhancement [modified response evaluation criteria in solid tumors (mRECIST)] assessed by external independent radiologists.
Refametenib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, refametinib in combination with sorafenib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning.
The primary endpoint (the most meaningful result to be tracked) of this study is based on the rate of response, i.e. the disease getting smaller. The aim is to show that the therapy with refametinib in combination with sorafenib improves the response rate in this patient population compared to historical results observed with the sorafenib only.
Refametenib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, refametinib in combination with sorafenib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning.
The primary endpoint (the most meaningful result to be tracked) of this study is based on the rate of response, i.e. the disease getting smaller. The aim is to show that the therapy with refametinib in combination with sorafenib improves the response rate in this patient population compared to historical results observed with the sorafenib only.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
14Trial Dates
September 2013 - February 2017Phase
Phase 2Could I Receive a placebo
NoProducts
Refametinib (BAY86-9766)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Wien, 1090, Austria | |
Completed | Singapore, 169610, Singapore | |
Withdrawn | Ann Arbor, 48109, United States | |
Completed | Hospitalet de Llobregat, 08907, Spain | |
Completed | Oviedo, 33011, Spain | |
Completed | Madrid, 28007, Spain | |
Completed | Hong Kong, NA, Hong Kong | |
Completed | Madrid, 28050, Spain | |
Completed | LYON, 69004, France | |
Withdrawn | CLICHY, 92110, France | |
Completed | CAEN CEDEX, 14033, France | |
Completed | BORDEAUX, 33000, France | |
Completed | PARIS, 75012, France | |
Withdrawn | Cleveland, 44106-2602, United States | |
Completed | Seoul, 06351, Korea, Republic Of | |
Completed | Seoul, 03722, Korea, Republic Of | |
Completed | Seoul, 05505, Korea, Republic Of | |
Completed | Seoul, 08308, Korea, Republic Of | |
Completed | Taipei, 10002, Taiwan | |
Withdrawn | Taoyuan, 333423, Taiwan | |
Completed | London, SE5 9RS, United Kingdom | |
Completed | EDEGEM, 2650, Belgium | |
Completed | LIEGE, 4000, Belgium | |
Completed | Bologna, 40138, Italy | |
Completed | Milano, 20122, Italy | |
Completed | Roma, 00168, Italy | |
Completed | Frankfurt, 60596, Germany | |
Completed | Hamburg, 20246, Germany | |
Completed | Tübingen, 72076, Germany | |
Completed | Magdeburg, 39120, Germany | |
Completed | Essen, 45147, Germany | |
Completed | Jerusalem, 9112001, Israel | |
Completed | Petach Tikva, 4941492, Israel | |
Completed | Tel Aviv, 64239, Israel | |
Completed | Haifa, 3109601, Israel | |
Withdrawn | Rehovot, 7610001, Israel | |
Withdrawn | Beer Sheva, 8410101, Israel | |
Completed | Chiang Mai, 50200, Thailand | |
Completed | Khon Kaen, 40002, Thailand | |
Completed | Songkhla, 90110, Thailand | |
Withdrawn | La Jolla, 92093, United States | |
Completed | Olomouc, 775 20, Czechia | |
Withdrawn | Praha 5, 150 06, Czechia | |
Completed | Hradec Kralove, 500 05, Czechia | |
Completed | Pecs, 7932, Hungary | |
Completed | Zalaegerszeg, 8900, Hungary | |
Completed | Istanbul, 34349, Turkey | |
Completed | Istanbul, 34093, Turkey | |
Completed | Istanbul, 34899, Turkey | |
Completed | Mersin, 33070, Turkey | |
Completed | Seoul, 06591, Korea, Republic Of | |
Completed | NICE CEDEX 3, 06202, France | |
Completed | Chiba-shi, 260-8677, Japan | |
Completed | Nagoya, 466-8560, Japan | |
Completed | Fukuoka-shi, 810-8563, Japan | |
Completed | Osaka, 534-0021, Japan | |
Completed | Kyoto, 606-8507, Japan | |
Completed | Irima-gun, 350-0495, Japan | |
Completed | Bunkyo-ku, 113-8655, Japan | |
Completed | Osaka, 545-8586, Japan | |
Completed | Yokohama, 241-8515, Japan | |
Completed | Itabashi-ku, 173-8610, Japan | |
Completed | Daegu, 700-721, Korea, Republic Of | |
Completed | Seoul, 110-744, Korea, Republic Of | |
Completed | SAINT-PRIEST-EN-JAREZ, 42270, France | |
Completed | Tainan, 736, Taiwan | |
Completed | LEUVEN, 3000, Belgium | |
Completed | BRUXELLES - BRUSSEL, 1070, Belgium | |
Completed | Berlin, 10967, Germany | |
Completed | VANDOEUVRE-LES-NANCY, 54511, France | |
Completed | MARSEILLE, 13005, France | |
Withdrawn | LILLE, 59037, France | |
Completed | Birmingham, B15 2TH, United Kingdom | |
Completed | Heidelberg, 69120, Germany | |
Completed | Debrecen, 4032, Hungary | |
Completed | Budapest, 1062, Hungary | |
Completed | Osakasayama-shi, 589-8511, Japan | |
Completed | Bern, 3010, Switzerland | |
Completed | Auckland, 1023, New Zealand | |
Completed | Milano, 20133, Italy | |
Completed | Vigo, 36071, Spain | |
Completed | Santiago de Compostela, 15706, Spain | |
Completed | Tainan, 704, Taiwan | |
Completed | Louisville, 40202, United States | |
Withdrawn | New York, 10029, United States | |
Completed | Hong Kong, Hong Kong | |
Completed | Essen, 45136, Germany | |
Withdrawn | Washington, 20007-2197, United States | |
Completed | Shanghai, 200032, China | |
Withdrawn | Beijing, 100853, China | |
Completed | Guangzhou, 510515, China | |
Completed | Beijing, 100071, China | |
Withdrawn | Nanjing, 210009, China | |
Withdrawn | Fairway, 66205, United States | |
Withdrawn | Hannover, 30625, Germany |
Primary Outcome
- Objective tumor response according to Modified Response Evaluation Criteria in Solid Tumors (mRECIST) assessed by central radiological reviewdate_rangeTime Frame:Approximately 36 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Objective tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by central radiological reviewdate_rangeTime Frame:Approximately 36 monthsenhanced_encryptionNoSafety Issue:
- Objective tumor response according to RECIST 1.1 and mRECIST assessed by investigatorsdate_rangeTime Frame:Approximately 36 monthsenhanced_encryptionNoSafety Issue:
- Disease control (central and investigator’s assessment)date_rangeTime Frame:Approximately 36 monthsenhanced_encryptionNoSafety Issue:
- Overall survivaldate_rangeTime Frame:Approximately 36 monthsenhanced_encryptionNoSafety Issue:
- Time to radiographic tumor progression (central and investigator’s assessment)date_rangeTime Frame:Approximately 36 monthsenhanced_encryptionNoSafety Issue:
- Duration of response (central and investigator’s assessment)date_rangeTime Frame:Approximately 36 monthsenhanced_encryptionNoSafety Issue:
- Time to objective response (central and investigator’s assessment).date_rangeTime Frame:Approximately 36 monthsenhanced_encryptionNoSafety Issue:
- Change in tumor size (central and investigator’s assessment)date_rangeTime Frame:Approximately 36 monthsenhanced_encryptionNoSafety Issue:
- Best overall response (central and investigator’s assessment)date_rangeTime Frame:Approximately 36 monthsenhanced_encryptionNoSafety Issue:
- Progression-free survival (central and investigator’s assessment)date_rangeTime Frame:Approximately 36 monthsenhanced_encryptionNoSafety Issue:
- Number of participants with adverse events as a measure of safety and tolerabilitydate_rangeTime Frame:Approximately 36 monthsenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1