check_circleStudy Completed
Carcinoma, Hepatocellular
Bayer Identifier:
16553
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Refametinib(BAY86-9766) in RAS mutant Hepatocellular Carcinoma (HCC)
Trial purpose
This is a study to investigate the potential clinical benefit of refametinib 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 confirmed partial response (PR) according to modified response evaluation criteria in solid tumors (mRECIST) assessed by central image review.
Refametinib 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 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 improves the response rate in this RAS mutation patient population.
Refametinib 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 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 improves the response rate in this RAS mutation patient population.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
16Trial Dates
September 2013 - October 2014Phase
Phase 2Could I Receive a placebo
NoProducts
Refametinib (BAY86-9766)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Bern, 3010, Switzerland | |
Completed | Rochester, 14642, United States | |
Completed | Barcelona, 08035, Spain | |
Completed | Alicante, 03010, Spain | |
Completed | Valencia, 46010, Spain | |
Completed | Santiago de Compostela, 15706, Spain | |
Completed | Shatin, Hong Kong | |
Completed | Graz, 8036, Austria | |
Completed | Pontevedra, 36071, Spain | |
Completed | Miami, 33136, United States | |
Completed | LILLE, 59037, France | |
Completed | VANDOEUVRE-LES-NANCY, 54511, France | |
Completed | MONTPELLIER CEDEX, 34059, France | |
Completed | CLERMONT-FERRAND Cedex 1, 63003, France | |
Withdrawn | Orange, 92868, United States | |
Withdrawn | Louisville, 40202, United States | |
Withdrawn | Los Angeles, 90095-7077, United States | |
Withdrawn | Galveston, 77555-0587, United States | |
Withdrawn | Atlanta, 30309, United States | |
Completed | CRETEIL, 94010, France | |
Completed | MARSEILLE, 13005, France | |
Completed | Daegu, 41404, Korea, Republic Of | |
Completed | Busan, 49241, Korea, Republic Of | |
Completed | Seoul, 03080, Korea, Republic Of | |
Completed | Auckland, 1023, New Zealand | |
Completed | Kaohsiung City, 8330, Taiwan | |
Completed | Tainan, 704, Taiwan | |
Completed | Birmingham, B15 2TT, United Kingdom | |
Completed | Washington, 20007-2197, United States | |
Completed | LEUVEN, 3000, Belgium | |
Completed | BRUXELLES - BRUSSEL, 1200, Belgium | |
Completed | GENT, 9000, Belgium | |
Completed | BRUXELLES - BRUSSEL, 1070, Belgium | |
Completed | Bangkok, 10700, Thailand | |
Completed | Bangkok, 10330, Thailand | |
Completed | Bangkok, 10210, Thailand | |
Completed | Hannover, 30625, Germany | |
Completed | München, 81377, Germany | |
Completed | Heidelberg, 69120, Germany | |
Completed | Berlin, 13353, Germany | |
Completed | Essen, 45136, Germany | |
Completed | Mainz, 55131, Germany | |
Completed | New York, 10029, United States | |
Withdrawn | Seattle, 98101, United States | |
Completed | Milano, 20089, Italy | |
Completed | Milano, 20133, Italy | |
Completed | Praha 2, 128 08, Czechia | |
Completed | Debrecen, 4032, Hungary | |
Completed | Budapest, 1062, Hungary | |
Completed | Charleroi, 6000, Belgium | |
Completed | Osakasayama-shi, 589-8511, Japan | |
Completed | Shimotsuke, 329-0498, Japan | |
Completed | Moriguchi, 570-8507, Japan | |
Completed | Sunto, 411-8777, Japan | |
Completed | Chuo-ku, 104-0045, Japan | |
Completed | Kashiwa-shi, 277-8577, Japan | |
Completed | Osaka, 543-8555, Japan | |
Completed | Osaka-shi, 541-8567, Japan | |
Completed | Kobe, 650-0017, Japan | |
Completed | Shizuoka, 420-8527, Japan | |
Withdrawn | Westwood, 66205, United States | |
Completed | Genève 14, 1211, Switzerland | |
Withdrawn | GENT, 9000, Belgium | |
Completed | Tampa, 33612, United States | |
Completed | Seoul, 135-710, Korea, Republic Of | |
Completed | Seoul, 05505, Korea, Republic Of |
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