check_circleStudy Completed
Neoplasms
Bayer Identifier:infoA unique number for a trial given by Bayer.
16443
ClinicalTrials.gov Identifier:infoA unique number for a trial given by United States government.
EudraCT Number:infoA unique reference for a trial given by European medical agency.
EU CT Number:infoA unique reference for a trial given by European medical agency under EU Clinical Trial Regulation
Not Available
Dose escalation pan-FGFR (fibroblast growth factor receptor) inhibitor (Rogaratinib)
Trial purpose
- This was the first study where BAY1163877 was given to humans. Impact of the study was to evaluate if patients with advanced solid cancers show advanced clinical benefit under the treatment with the pan FGFR inhibitor. Patients (all comers) received the study drug treatment in a dose-escalation scheme (no placebo group) to determine the safety, tolerability and maximum tolerated dose (MTD) of BAY1163877. The relative bioavailability of liquid service formulation and tablets was determined.
- After the MTD was defined patients with solid tumors (all comers), lung cancer (lung adenocarcinoma & squamous non-small cell lung cancer), head and neck cancer or bladder cancer was enrolled according to their FGFR expression profile (biomarker stratification).
- The study also assessed the pharmacokinetics, biomarker status, pharmacodynamic parameters and tumor response of BAY1163877.
- BAY1163877 was given twice daily as oral application. Treatment was stopped if the tumor continued to grow, if side effects, which the patient cannot tolerate, occurred or if the patient decided to exit treatment.
- After the MTD was defined patients with solid tumors (all comers), lung cancer (lung adenocarcinoma & squamous non-small cell lung cancer), head and neck cancer or bladder cancer was enrolled according to their FGFR expression profile (biomarker stratification).
- The study also assessed the pharmacokinetics, biomarker status, pharmacodynamic parameters and tumor response of BAY1163877.
- BAY1163877 was given twice daily as oral application. Treatment was stopped if the tumor continued to grow, if side effects, which the patient cannot tolerate, occurred or if the patient decided to exit treatment.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal info
168The overall number of participants needed for a trial.
Trial Dates info
December 2013 - January 2020Trial dates are when the trial starts and ends. If they are in the future, then they are estimates and can change before or during a trial.
Phase info
Phase 1A phase is a step in the research of a new treatment.
Could I Receive a placebo info
NoA “placebo” looks like a treatment but usually does not have any real treatment. A placebo is used to make sure the effects of a treatment that are seen in a trial are actually caused by that treatment.
Products info
Rogaratinib (BAY1163877)A “product” can be any kind of drug, medical device, vaccine, or other treatment that is being studied in a trial.
Accepts Healthy Volunteer info
NoA healthy volunteer is a person who takes part in a trial but does not have a disease or condition. Usually, healthy volunteers are in Phase 1 trials.
Where to participate
Status | Institution | Location |
---|---|---|
Completed | Würzburg, 97080, Germany | |
Completed | Essen, 45147, Germany | |
Completed | Seoul, 03722, Korea, Republic Of | |
Completed | St. Gallen, 9007, Switzerland | |
Completed | Singapore, 119228, Singapore | |
Completed | Singapore, 169610, Singapore | |
Completed | Seoul, 03080, Korea, Republic Of | |
Completed | Barcelona, 08035, Spain | |
Completed | Köln, 50937, Germany | |
Completed | LYON CEDEX, 69008, France | |
Completed | Heidelberg, 69120, Germany | |
Completed | Magdeburg, 39120, Germany | |
Completed | Dresden, 01307, Germany | |
Withdrawn | Jena, 07740, Germany | |
Withdrawn | Lübeck, 23538, Germany | |
Completed | Chicago, 60611-2908, United States | |
Completed | CRETEIL, 94010, France | |
Completed | LILLE CEDEX, 59020, France | |
Completed | DIJON, 21079, France | |
Completed | Chicago, United States | |
Completed | Weiden, 92637, Germany | |
Completed | Tübingen, 72076, Germany | |
Completed | Hamburg, 20246, Germany | |
Withdrawn | Bochum, 44791, Germany | |
Completed | BESANCON, 25030, France | |
Completed | Madrid, 28034, Spain | |
Completed | Chur, 7000, Switzerland | |
Completed | Seoul, 135-710, Korea, Republic Of | |
Completed | Pittsburgh, 15232, United States | |
Completed | Madrid, 28041, Spain | |
Completed | Valencia, 46014, Spain | |
Completed | Genève, 1205, Switzerland | |
Withdrawn | Bern, 3010, Switzerland |
Primary OutcomeinfoA primary outcome is the most important effect of a treatment that is measured in a trial. Most trials have one primary outcome measure, but some have more than one.
- Maximum tolerated dose (MTD), defined as maximum dose at which the incidence of Dose Limiting Toxicities (DLTs) during Cycle 1 is below 20%The MTD was defined as maximum dose at which the incidence of Dose Limiting Toxicities (DLTs) during Cycle 1 is below 20%. DLT was defined as any of the pre-defined adverse events occurring during Cycle 1 of a dose level and regarded by the investigators and/or sponsor to be related to the investigational drug. BID=twice daily.date_rangeTime Frame:Up to 21 days
- Number of DLTs during Cycle 1DLT was defined as any of the pre-defined adverse events occurring during Cycle 1 of a dose level and regarded by the investigators and/or sponsor to be related to the investigational drug.date_rangeTime Frame:Up to 21 days
- Cmax (maximum drug concentration in plasma) of BAY1163877 after single dose administration on Cycle 1, Day -3Maximum drug concentration in plasma (Cmax) of BAY1163877 after single dose administration on Cycle 1, Day -3. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day -2) and 48 hour(s) post-dose (Day -1)
- Cmax (maximum drug concentration in plasma) of BAY1163877 after single dose administration on Cycle 1, Day 1Maximum drug concentration in plasma (Cmax) of BAY1163877 after single dose administration on Cycle 1, Day 1. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day 1) and 48 hour(s) post-dose (Day 2)
- AUC(0-12) (area under the plasma concentration vs time curve from time zero to 12 hours) of BAY1163877 after single dose administration on Cycle 1, Day -3Area under the plasma concentration vs time curve from time zero to 12 hours (AUC(0-12)) of BAY1163877 after single dose administration on Cycle 1, Day -3. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day -2) and 48 hour(s) post-dose (Day -1)
- AUC(0-12) (area under the plasma concentration vs time curve from time zero to 12 hours) of BAY1163877 after single dose administration on Cycle 1, Day 1Area under the plasma concentration vs time curve from time zero to 12 hours (AUC(0-12)) of BAY1163877 after single dose administration on Cycle 1, Day 1. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day 1) and 48 hour(s) post-dose (Day 2)
- AUC(0-tlast) (area under the plasma concentration vs time curve from time zero to the last data point > LLOQ [lower limit of quantification]) of BAY1163877 after single dose administration on Cycle 1, Day -3Area under the plasma concentration vs time curve from time zero to the last data point > LLOQ [lower limit of quantification] (AUC(0-tlast)) of BAY1163877 after single dose administration on Cycle 1, Day -3. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day -2) and 48 hour(s) post-dose (Day -1)
- AUC(0-tlast) (area under the plasma concentration vs time curve from time zero to the last data point > LLOQ [lower limit of quantification]) of BAY1163877 after single dose administration on Cycle 1, Day 1Area under the plasma concentration vs time curve from time zero to the last data point > LLOQ [lower limit of quantification] (AUC(0-tlast)) of BAY1163877 after single dose administration on Cycle 1, Day 1. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day 1) and 48 hour(s) post-dose (Day 2)
- AUC (area under the plasma concentration vs time curve from zero to infinity) of BAY1163877 after single dose administration on Cycle 1, Day -3Area under the plasma concentration vs time curve from zero to infinity (AUC) of BAY1163877 after single dose administration on Cycle 1, Day -3. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day -2) and 48 hour(s) post-dose (Day -1)
- AUC (area under the plasma concentration vs time curve from zero to infinity) of BAY1163877 after single dose administration on Cycle 1, Day 1Area under the plasma concentration vs time curve from zero to infinity (AUC) of BAY1163877 after single dose administration on Cycle 1, Day 1. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day 1) and 48 hour(s) post-dose (Day 2)
- Cmax/D (maximum drug concentration in plasma divided by dose) of BAY1163877 after single dose administration on Cycle 1, Day -3Maximum drug concentration in plasma divided by dose (Cmax/D) of BAY1163877 after single dose administration on Cycle 1, Day -3. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day -2) and 48 hour(s) post-dose (Day -1)
- Cmax/D (maximum drug concentration in plasma divided by dose) of BAY1163877 after single dose administration on Cycle 1, Day 1Maximum drug concentration in plasma divided by dose (Cmax/D) of BAY1163877 after single dose administration on Cycle 1, Day 1. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day 1) and 48 hour(s) post-dose (Day 2)
- AUC(0-12)/D (area under the plasma concentration vs time curve from time zero to 12 hours divided by dose) of BAY1163877 after single dose administration on Cycle 1, Day -3Area under the plasma concentration vs time curve from time zero to 12 hours divided by dose (AUC(0-12)/D) of BAY1163877 after single dose administration on Cycle 1, Day -3. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day -2) and 48 hour(s) post-dose (Day -1)
- AUC(0-12)/D (area under the plasma concentration vs time curve from time zero to 12 hours divided by dose) of BAY1163877 after single dose administration on Cycle 1, Day 1Area under the plasma concentration vs time curve from time zero to 12 hours divided by dose (AUC(0-12)/D) of BAY1163877 after single dose administration on Cycle 1, Day 1. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day 1) and 48 hour(s) post-dose (Day 2)
- AUC(0-tlast)/D (area under the plasma concentration vs time curve from time zero to the last data point > LLOQ divided by dose) of BAY1163877 after single dose administration on Cycle 1, Day -3Area under the plasma concentration vs time curve from time zero to the last data point > LLOQ divided by dose (AUC(0-tlast)/D) of BAY1163877 after single dose administration on Cycle 1, Day -3. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day -2) and 48 hour(s) post-dose (Day -1)
- AUC(0-tlast)/D (area under the plasma concentration vs time curve from time zero to the last data point > LLOQ divided by dose) of BAY1163877 after single dose administration on Cycle 1, Day 1Area under the plasma concentration vs time curve from time zero to the last data point > LLOQ divided by dose (AUC(0-tlast)/D) of BAY1163877 after single dose administration on Cycle 1, Day 1. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day 1) and 48 hour(s) post-dose (Day 2)
- AUC/D (AUC divided by dose) of BAY1163877 after single dose administration on Cycle 1, Day -3AUC divided by dose (AUC/D) of BAY1163877 after single dose administration on Cycle 1, Day -3. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day -2) and 48 hour(s) post-dose (Day -1)
- AUC/D (AUC divided by dose) of BAY1163877 after single dose administration on Cycle 1, Day 1AUC divided by dose (AUC/D) of BAY1163877 after single dose administration on Cycle 1, Day 1. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day 1) and 48 hour(s) post-dose (Day 2)
- Cmax,md (Cmax after multiple-dose administration) of BAY1163877 on Cycle 1, Day 15Cmax,md (Cmax after multiple-dose administration) of BAY1163877. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:pre-dose (before morning dose), and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose
- Cmax/Dmd (Cmax divided by dose after multiple-dose administration) of BAY1163877 on Cycle 1, Day 15Cmax/Dmd (Cmax divided by dose after multiple-dose administration) of BAY1163877. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:pre-dose (before morning dose), and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose
- AUC(0-12)md (AUC(0-12) after multiple-dose administration) of BAY1163877 on Cycle 1, Day 15AUC(0-12)md (AUC(0-12) after multiple-dose administration) of BAY1163877. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:pre-dose (before morning dose), and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose
- AUC(0-12)/Dmd (AUC(0-12) divided by dose after multiple-dose administration) of BAY1163877 on Cycle 1, Day 15AUC(0-12)/Dmd (AUC(0-12) divided by dose after multiple-dose administration) of BAY1163877. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:pre-dose (before morning dose), and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose
- AUC(0-tlast)md (AUC(0-tlast) after multiple dose administration) of BAY1163877 on Cycle 1, Day 15AUC(0-tlast)md (AUC(0-tlast) after multiple dose administration) of BAY1163877. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:pre-dose (before morning dose), and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose
- AUC(0-tlast)/Dmd (AUC(0-tlast) divided by dose after multiple-dose administration) of BAY1163877 on Cycle 1, Day 15AUC(0-tlast)/Dmd (AUC(0-tlast) divided by dose after multiple-dose administration) of BAY1163877. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:pre-dose (before morning dose), and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose
- %AE,ur(0-12) (amount of drug excreted via urine during the collection interval 0 - 12 hours post administration) of BAY1163877%AE,ur(0-12) (amount of drug excreted via urine during the collection interval 0 - 12 hours post administration, also expressed as percent of dose administered) of BAY1163877.date_rangeTime Frame:On Cycle1, Day 1
- %AE,ur(0-24) (amount of drug excreted via urine during the collection interval 0 - 24 hours post administration) of BAY1163877%AE,ur(0-24) (amount of drug excreted via urine during the collection interval 0 - 24 hours post administration, also expressed as percent of dose administered) of BAY1163877.date_rangeTime Frame:On Cycle1, Day 1
- %AE,ur(12-24) (amount of drug excreted via urine during the collection interval 12 - 24 hours post administration) of BAY1163877%AE,ur(12-24) (amount of drug excreted via urine during the collection interval 12 - 24 hours post administration, also expressed as percent of dose administered) of BAY1163877.date_rangeTime Frame:On Cycle1, Day 1
Secondary OutcomeinfoA secondary outcome is an effect of a treatment that is measured in a trial. A secondary outcome is less important than a primary outcome. But secondary outcomes are still important since they help researchers learn more about the effects of a treatment. Most clinical trials have more than one secondary outcome measure.
- Response Rate as Defined by RECIST Version 1.1 Reported as Number of Participants With Different Response TypeResponse as defined by RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1: complete response (CR: disappearance of all target lesions), partial response (PR: at least a 30% decrease in the sum of diameters of target lesions taking as the reference the baseline sum of diameters), stable disease (SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference, the smallest sum of diameters while in the trial), progressive disease (PD: at least a 20% increase in the sum of diameters of the target lesions, taking as a references the smallest sum on study).date_rangeTime Frame:Up to 2 years
- Progression-free survival (PFS)PFS was defined as the time (days) from the date of the first dose of study drug to the date of the first observed disease progression (radiological or clinical) or death due to any cause, if death occurred before progression was documented. PFS for participants without tumor progression at the time of analysis was censored at their last date of tumor evaluation.date_rangeTime Frame:Up to 2 years
- Time to progression (TTP)TTP was defined as the time from start of study treatment until first observed disease progression (radiological or clinical). Progression is defined using RECIST v1.0, as at least a 20% increase in the sum of diameters of the target lesions, taking as a references the smallest sum on study.date_rangeTime Frame:Up to 2 years
- Duration of response (DOR)DOR (for partial and complete response (PR/CR)) was defined as the time (days) from the first documented objective response of PR or CR, whichever was noted earlier, to disease progression or death (if death occurred before progression was documented). DOR was calculated for responders only, i.e. participants with complete or partial response. Therefore, the dose escalation group is not displayed.date_rangeTime Frame:Up to 2 years
- Duration of treatment (DOT)date_rangeTime Frame:Up to 2 years
- Evaluation of biomarker status –change in serum FGF23 (Fibroblast Growth Factor 23) levels from baseline to C2D1Change in serum FGF23 levels from baseline to C2D1 was reported as ratio to baseline (%).date_rangeTime Frame:From baseline to C2D1
- Evaluation of Pharmacodynamic Parameters (PD) – change of heart rate (HR) from baseline to end of studydate_rangeTime Frame:From baseline up to 2 years
- Evaluation of Pharmacodynamic Parameters (PD) – change of blood pressure (BP) from baseline to end of studydate_rangeTime Frame:From baseline up to 2 years
- Evaluation of Pharmacodynamic Parameters (PD) - Change of QT Intervals From Baseline up to Cycle 1, Day 15date_rangeTime Frame:From baseline up to Cycle 1, Day 15
- Evaluation of relative bioavailability of the tablet formulation in comparison to the solution formulation of BAY1163877In order to evaluate the relative bioavailability of the tablet formulation, tablet Cmax/D, AUC(0-tlast)/D, and AUC/D on Cycle 1, Day -3 were compared to solution Cmax/D, AUC(0-tlast)/D, AUC/D on Cycle 1, Day 1 for all analytes. The logarithms of the PK parameters were analyzed using analysis of variance (ANOVA) including participant and formulation effects. Based on these analyses, point estimates (LS-means) and exploratory 90% confidence intervals for the ratios (tablet/solution) of Cmax/D, AUC(0- tlast)/D, and AUC/D were calculated by re-transformation of the logarithmic data using the intra-individual standard deviation of the ANOVA.date_rangeTime Frame:On Cycle 1, Day -3 and Cycle 1, Day 1
- Tmax (time to reach maximum drug concentration in plasma) of BAY1163877 after single dose administration on Cycle 1, Day -3 and Cycle 1, Day 1Tmax (time to reach maximum drug concentration in plasma) of BAY1163877 after single dose administration on Cycle 1, Day -3 and Cycle 1, Day 1. Median and full range were reported.date_rangeTime Frame:pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hour(s) post-dose
- Tlast (time of last plasma concentration above LLOQ) of BAY1163877 after single dose administration on Cycle 1, Day -3 and Cycle 1, Day 1Tlast (time of last plasma concentration above LLOQ) of BAY1163877 after single dose administration on Cycle 1, Day -3 and Cycle 1, Day 1. Median and full range were reported.date_rangeTime Frame:pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hour(s) post-dose
- T1/2 (half-life associated with the terminal slope) of BAY1163877 after single dose administration on Cycle 1, Day -3 and Cycle 1, Day 1T1/2 (half-life associated with the terminal slope) of BAY1163877 after single dose administration on Cycle 1, Day -3 and Cycle 1, Day 1. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame:pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hour(s) post-dose
- Tmax,md (time to reach maximum drug concentration in plasma after multiple-dose administration) of BAY1163877 on Cycle 1, Day 15Tmax,md (time to reach maximum drug concentration in plasma after multiple-dose administration) of BAY1163877. Median and full range were reported.date_rangeTime Frame:pre-dose (before morning dose), and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose
- Tlast,md (time of last plasma concentration above LLOQ after multiple-dose administration) of BAY1163877 on Cycle 1, Day 15Tlast,md (time of last plasma concentration above LLOQ after multiple-dose administration) of BAY1163877. Median and full range were reported.date_rangeTime Frame:pre-dose (before morning dose), and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose
Trial design
Trial Type info
InterventionalDescribes the nature of the clinical study.
Intervention Type info
DrugAn intervention is a drug, medical device, vaccine, or other treatment that is being studied in a trial or is already approved for all patients to use. An intervention can also include treatments like changing diet and exercise, or educating people about a health topic.
Trial Purpose info
TreatmentThe main reason the clinical trial is being done.
Allocation info
Non-randomizedAllocation is the way treatments are assigned to the people in the trial.
Blinding info
Open Label“Blinding” means a person in a trial does not know what treatment they are using. Everyone in the trial knows which treatments they might get if they join the trial, but they do not always know which treatment they use during the trial.
Assignment info
Single Group AssignmentAn “assignment” is the way that people in a trial are assigned to use a treatment.
Trial Arms info
5A “trial arm” is a group of people in a trial. Each trial arm is assigned to use a specific treatment. Types of trial arms are: Experimental arm is a group assigned to use the treatment being studied in the trial Active comparator arm is a group assigned to use a treatment considered to be effective. The results of this group are compared to the results of the experimental arm. Placebo arm is a group assigned to use a placebo. A “placebo” looks like a treatment but usually does not have any real treatment. The results of this group are compared to the experimental arm. This helps make sure any effects that are seen in the experimental arm are actually caused by the main treatment being studied. No intervention arm is a group that is not assigned to use a treatment. The people in this group do not use any treatment during the trial.