stop_circleTerminated/Withdrawn
Neoplasms
Bayer Identifier:
17064
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Refametinib (BAY86-9766) in combination with regorafenib (Stivarga, BAY73-4506) in patients with advanced or metastatic cancer
Trial purpose
Phase I: Determine the maximum tolerated dose of combination of Regorafenib with Refametinib through a dose escalation study, all tumor types that meet certain inclusion/exclusion criteria can be entered.
After the recommended dose is determined, the Phase II portion of the study will evaluate tolerability and efficacy of the combination treatment in patients with breast cancer, lung cancer, or colorectal cancer, respectively.
After the recommended dose is determined, the Phase II portion of the study will evaluate tolerability and efficacy of the combination treatment in patients with breast cancer, lung cancer, or colorectal cancer, respectively.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
20Trial Dates
June 2014 - April 2016Phase
Phase 1Could I Receive a placebo
NoProducts
Refametinib (BAY86-9766)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Houston, 77030, United States | |
Completed | St. Louis, 63110, United States | |
Completed | Chapel Hill, 27599, United States | |
Completed | Detroit, 48201, United States | |
Completed | New Haven, 06510, United States | |
Withdrawn | Erasmus Medisch Centrum | ROTTERDAM, 3015 CE, Netherlands |
Withdrawn | Universitätsklinikum Köln | Köln, 50937, Germany |
Withdrawn | LMU Klinikum der Universität München - Großhadern | München, 81377, Germany |
Withdrawn | Medizinische Fakultät Carl Gustav Carus | Dresden, 01307, Germany |
Withdrawn | Marienhospital | Stuttgart, 70199, Germany |
Withdrawn | A.O.U. San Luigi Gonzaga | Orbassano, 10043, Italy |
Withdrawn | IRCCS Istituto Clinico Humanitas | Rozzano, 20089, Italy |
Withdrawn | A.O. San Gerardo | Monza, 20900, Italy |
Withdrawn | A.O.U. di Bologna | Bologna, 40138, Italy |
Withdrawn | A.O.U. Pisana | Pisa, 56126, Italy |
Withdrawn | Fondazione Poliambulanza - Istituto Ospedaliero | Brescia, 25124, Italy |
Withdrawn | Università Cattolica del Sacro Cuore | Roma, 00168, Italy |
Withdrawn | Hadassah Hebrew University Hospital Ein Kerem | Jerusalem, 9112001, Israel |
Withdrawn | Rabin Medical Center - Beilinson Campus | Petah Tikva, 4941492, Israel |
Withdrawn | Tel-Aviv Sourasky Medical Center | Tel Aviv, 6423906, Israel |
Withdrawn | Rambam Health Corporation | Haifa, 3109601, Israel |
Withdrawn | Meir Medical Center | Kfar Saba, 4428164, Israel |
Withdrawn | Chaim Sheba Medical Center | Ramat Gan, 5262000, Israel |
Withdrawn | Centre René Gauducheau - Nantes | NANTES, 44805, France |
Withdrawn | Institut de Cancérologie de l’Ouest (ICO) | ANGERS CEDEX, 49933, France |
Withdrawn | Centre Oscar Lambret - Lille | LILLE CEDEX, 59020, France |
Withdrawn | Centre Léon Bérard | LYON CEDEX, 69008, France |
Withdrawn | Hôpital Henri Mondor - Créteil | CRETEIL CEDEX, 94000, France |
Withdrawn | Institut du Cancer de Montpellier | MONTPELLIER Cedex 5, 34298, France |
Withdrawn | Hôpital de Rangueil - Toulouse | TOULOUSE CEDEX 9, 31059, France |
Withdrawn | Institut Claudius Regaud - iUCT Oncopole | TOULOUSE CEDEX 9, 31059, France |
Withdrawn | Universitätsklinikum Ulm | Ulm, 89091, Germany |
Withdrawn | Klinikum Oldenburg GmbH | Oldenburg, 26133, Germany |
Withdrawn | Scientific Research Instutute of Oncology n.a. N.N. Petrov | St. Petersburg, 197758, Russia |
Withdrawn | Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS | Moscow, 115478, Russia |
Withdrawn | Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS | Moscow, 115478, Russia |
Withdrawn | Central Clinical Hospital #2 n.a. Semashko of JSC "RRW" | Moscow, 129128, Russia |
Withdrawn | Leningrad Regional Oncology Dispensary | St. Petersburg, 191104, Russia |
Primary Outcome
- Maximum drug concentration in plasma after multiple dose (Cmax,md) for RefametinibMaximum drug concentration in plasma after multiple dose for Refametinib. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 12 hours post-doseenhanced_encryptionNoSafety Issue:
- Maximum drug concentration in plasma after multiple dose (Cmax,md) for Refametinib metabolite M-11Maximum drug concentration in plasma after multiple dose for Refametinib metabolite M-11. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 12 hours post-doseenhanced_encryptionNoSafety Issue:
- Area under the plasma concentration-time curve from 0 to 12 h after multiple dose (AUC(0-12)md) for RefametinibArea under the plasma concentration-time curve from 0 to 12 h after multiple dose for Refametinib. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 12 hours post-doseenhanced_encryptionNoSafety Issue:
- Area under the plasma concentration-time curve from 0 to 12 h after multiple dose (AUC(0-12)md) for Refametinib metabolite M-11Area under the plasma concentration-time curve from 0 to 12 h after multiple dose for Refametinib metabolite M-11. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 12 hours post-doseenhanced_encryptionNoSafety Issue:
- Maximum drug concentration in plasma after multiple dose (Cmax,md) for RegorafenibMaximum drug concentration in plasma after multiple dose for Regorafenib. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-doseenhanced_encryptionNoSafety Issue:
- Maximum drug concentration in plasma after multiple dose (Cmax,md) for Regorafenib metabolite M-2Maximum drug concentration in plasma after multiple dose for Regorafenib metabolite M-2. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-doseenhanced_encryptionNoSafety Issue:
- Maximum drug concentration in plasma after multiple dose (Cmax,md) for Regorafenib metabolite M-5Maximum drug concentration in plasma after multiple dose for Regorafenib metabolite M-5. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-doseenhanced_encryptionNoSafety Issue:
- Area under the plasma concentration-time curve from 0 to 24 h after multiple dose (AUC(0-24)md) for RegorafenibArea under the plasma concentration-time curve from 0 to 24 h after multiple dose for Regorafenib. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-doseenhanced_encryptionNoSafety Issue:
- Area under the plasma concentration-time curve from 0 to 24 h after multiple dose (AUC(0-24)md) for Regorafenib metabolite M-2Area under the plasma concentration-time curve from 0 to 24 h after multiple dose for Regorafenib metabolite M-2. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-doseenhanced_encryptionNoSafety Issue:
- Area under the plasma concentration-time curve from 0 to 24 h after multiple dose (AUC(0-24)md) for Regorafenib metabolite M-5Area under the plasma concentration-time curve from 0 to 24 h after multiple dose for Regorafenib metabolite M-5. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-doseenhanced_encryptionNoSafety Issue:
- Tumor response during Phase 2 as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1Tumor Response was defined as the best tumor response (Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes.date_rangeTime Frame:Up to 12 monthsenhanced_encryptionNoSafety Issue:
- Number of participants with dose limiting toxicities (DLTs)Dose-limiting toxicities (DLTs) were analyzed in the maximum tolerated dose (MTD) analysis set, in which only the six first patients of each dose escalation Cohort could be included according to the modified Rolling-6 method that was applied in this study.date_rangeTime Frame:At Cycle 1enhanced_encryptionYesSafety Issue:
Secondary Outcome
- Maximum drug concentration in plasma after single (first) dose (Cmax) for Refametinib and its metabolite M-11Maximum drug concentration in plasma after single (first) dose for Refametinib and its metabolite M-11. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:Cycle 1 Day 1 at 0 (pre-dose), 0.5, 1, 2, 4 and 8 hours post-doseenhanced_encryptionNoSafety Issue:
- Time to reach maximum drug concentration in plasma after single (first) dose (tmax) for Refametinib and its metabolite M-11Time to reach maximum drug concentration in plasma after single (first) dose for Refametinib and its metabolite M-11. Median and full range were reported.date_rangeTime Frame:Cycle 1 Day 1 at 0 (pre-dose), 0.5, 1, 2, 4 and 8 hours post-doseenhanced_encryptionNoSafety Issue:
- Area under the plasma concentration-time curve from 0 to 8 h (AUC(0-8)) after single (first) dose for Refametinib and its metabolite M-11Area under the plasma concentration-time curve from 0 to 8 h after single (first) dose for Refametinib and its metabolite M-11. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:Cycle 1 Day 1 at 0 (pre-dose), 0.5, 1, 2, 4 and 8 hours post-doseenhanced_encryptionNoSafety Issue:
- Time to reach maximum drug concentration in plasma after multiple dose (tmax,md) for Refametinib and its metabolite M-11Time to reach maximum drug concentration in plasma after multiple dose for Refametinib and its metabolite M-11. Median and full range were reported.date_rangeTime Frame:Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 12 hours post-doseenhanced_encryptionNoSafety Issue:
- Maximum drug concentration in plasma after single (first) dose (Cmax) for Regorafenib and its metabolites M-2 and M-5Maximum drug concentration in plasma after single (first) dose for Regorafenib and its metabolites M-2 and M-5. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:Cycle 1 Day 1 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 24 hours post-doseenhanced_encryptionNoSafety Issue:
- Time to reach maximum drug concentration in plasma after single (first) dose (tmax) for Regorafenib and its metabolites M-2 and M-5Time to reach maximum drug concentration in plasma after single (first) dose for Regorafenib and its metabolites M-2 and M-5. Median and full range were reported.date_rangeTime Frame:Cycle 1 Day 1 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 24 hours post-doseenhanced_encryptionNoSafety Issue:
- Area under the plasma concentration-time curve from 0 to 24 h (AUC(0-24)) after single (first) dose for Regorafenib and its metabolites M-2 and M-5Area under the plasma concentration-time curve from 0 to 24 h after single (first) dose for Regorafenib and its metabolites M-2 and M-5. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:Cycle 1 Day 1 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 24 hours post-doseenhanced_encryptionNoSafety Issue:
- Time to reach maximum drug concentration in plasma after multiple dose (tmax,md) for Regorafenib and its metabolites M-2 and M-5Time to reach maximum drug concentration in plasma after multiple dose for Regorafenib and its metabolites M-2 and M-5. Median and full range were reported.date_rangeTime Frame:Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-doseenhanced_encryptionNoSafety Issue:
- Tumor response during Phase 1b as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1Tumor Response was defined as the best tumor response (Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappeareance of all target and non-target tumor lesions, PR was defined as a decrease of at least 30% in the sum of diameters of target lesions, SD was defined neither sufficient shrinkage for PR nor sufficient increase for PD, PD was defined as an increase of at least 20% in the sum of diameters of target lesions.date_rangeTime Frame:From start of treatment until progression is documentedenhanced_encryptionNoSafety Issue:
- Overall survival during Phase 2Overall survival (OS) was defined as the time (days) from the treatment start date to the date of death due to any cause. For participants who were still alive or who were lost to follow-up as of the database cutoff date for the primary completion, OS was censored at the last known alive date on or prior to the database cutoff date.date_rangeTime Frame:Up to 12 months after last patient first visitenhanced_encryptionNoSafety Issue:
- Time to progression during Phase 2Time to progression was defined as the time (days) from the treatment start date to the disease progression on or following the start date. Participants not experiencing progression at the database cutoff date for primary completion were censored at the last assessment.date_rangeTime Frame:From start of treatment until progression is documentedenhanced_encryptionNoSafety Issue:
- Progression-free survival during Phase 2Progression-free survival was defined as the time from date of treatment assignment to date of first observed disease progression or death due to any cause, if death occurred while the participant was in the study and before progression was observed.date_rangeTime Frame:From start of treatment until progression is documentedenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
3Additional Information
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