Trial · NCT01853046
Pharmacokinetics and Safety of Regorafenib (BAY73-4506) in Cancer Subjects With Severe Renal Impairment
NCT01853046, Phase 1, Completed, Bayer; results first posted 2017-02-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pharmacokinetics and Safety of Regorafenib (BAY73-4506) in Cancer Subjects With Severe Renal Impairment. Trials, record NCT01853046. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01853046
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacokinetics and Safety of Regorafenib (BAY73-4506) in Cancer Subjects With Severe Renal Impairment
- NCT number
- NCT01853046
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 24 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Neoplasms
- Interventions
- Regorafenib (Stivarga, BAY73-4506)
- First posted
- 2013-05-14
- Last updated
- 2017-02-20
- Results first posted
- 2017-02-20
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | AUC(0-tlast) [Area Under the Concentration-time Curve After Single (First) Dose From Time Zero to the Last Data Point >LLOQ (Lower Limit of Quantification)] for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5 | Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose | Based on non-compartmental PK evaluation. The AUC(0-tlast) \[Area Under the Concentration-time Curve After Single (First) Dose From Time Zero to the Last Data Point \>LLOQ (Lower Limit of Quantification)\] is a measure of systemic drug exposure from time 0 up to the time point at which the last measurable drug could be detectable, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. |
| Primary | AE,ur(0-24) (Amount of Drug Excreted Via Urine During the Collection Interval 0-24 Hours Post Administration) for Metabolites M-7 and M-8 | Days 1-2: 0-24 hours | Amount of drug excreted into urine during the collection interval 0-24 hours post dose was expressed as percentage of administered dose. |
| Secondary | AUC (Area Under the Plasma Concentration vs. Time Curve From Zero to Infinity After Single (First) Dose) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5 | Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose | Based on non-compartmental PK evaluation. AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. |
| Secondary | AUC(0-24) (AUC From Time Zero to 24 Hours p.a. After Single (First) Dose Administration) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5 | Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10 and 24 hours post-dose | Based on non-compartmental PK evaluation. The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; AUC(0-24) is defined as AUC divided from zero to 24 hours after single (first) dose. |
| Secondary | Cmax (Maximum Drug Concentration in Plasma After Single (First) Dose Administration) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5 | Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose | Based on non-compartmental PK evaluation.Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. |
| Secondary | Tmax (Time to Reach Maximum Drug Concentration in Plasma After Single (First) Dose) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5 | Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose | Based on non-compartmental PK evaluation.Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content. |
| Secondary | Tlast (Time of Last Data Point >LLOQ) After Single (First) Dose for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5 | Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose | based on non-compartmental PK evaluation. |
| Secondary | t1/2 (Half-life Associated With the Terminal Slope) After Single (First) Dose for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5 | Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose | Based on non-compartmental PK evaluation. t1/2 refers to the elimination of the drug. It is the time taken for the blood plasma concentration to reach half the concentration in the terminal phase of elimination. It is expressed in hours (h) and derived from the terminal slope of the concentration versus time curve. |
| Secondary | CL/F (Total Body Clearance of Drug After Extravascular Administration) After Single (First) Dose for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5 | Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose | Based on non-compartmental PK evaluation.Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. |
| Secondary | Vz/F (Apparent Volume of Distribution During Terminal Phase After Single (First) Oral Administration) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5 | Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose | Based on non-compartmental PK evaluation.Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | AUC(0-tlast) [Area Under the Concentration-time Curve After Single (First) Dose From Time Zero to the Last Data Point >LLOQ (Lower Limit of Quantification)] for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5 | Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose | mg*h/L | GEOMETRIC_MEAN | |
| PRIMARY | AE,ur(0-24) (Amount of Drug Excreted Via Urine During the Collection Interval 0-24 Hours Post Administration) for Metabolites M-7 and M-8 | Days 1-2: 0-24 hours | Participants with a valid pharmacokinetic profile for non compartmental analysis were reported. | percentage of dose | MEAN |
| SECONDARY | AUC (Area Under the Plasma Concentration vs. Time Curve From Zero to Infinity After Single (First) Dose) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5 | Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose | Participants with a valid pharmacokinetic profile for non compartmental analysis were reported. | mg*h/L | GEOMETRIC_MEAN |
| SECONDARY | AUC(0-24) (AUC From Time Zero to 24 Hours p.a. After Single (First) Dose Administration) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5 | Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10 and 24 hours post-dose | In Normal/mild renal impairment group, participants analyzed for regorafenib, M-2 and M-5 are n=18, 18, and 17 respectively. In Severe renal impairment group, participants analyzed for regorafenib, M-2 and M-5 are n=6, 6, and 5 respectively. Participants with a valid pharmacokinetic profile for non compartmental analysis were reported. | mg*h/L | GEOMETRIC_MEAN |
| SECONDARY | Cmax (Maximum Drug Concentration in Plasma After Single (First) Dose Administration) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5 | Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose | mg/L | GEOMETRIC_MEAN | |
| SECONDARY | Tmax (Time to Reach Maximum Drug Concentration in Plasma After Single (First) Dose) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5 | Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose | h | MEDIAN | |
| SECONDARY | Tlast (Time of Last Data Point >LLOQ) After Single (First) Dose for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5 | Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose | h | MEDIAN | |
| SECONDARY | t1/2 (Half-life Associated With the Terminal Slope) After Single (First) Dose for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5 | Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose | Participants with a valid pharmacokinetic profile for non compartmental analysis were reported. | h | GEOMETRIC_MEAN |
| SECONDARY | CL/F (Total Body Clearance of Drug After Extravascular Administration) After Single (First) Dose for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5 | Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose | Participants with a valid pharmacokinetic profile for non compartmental analysis were reported. | L/H | GEOMETRIC_MEAN |
| SECONDARY | Vz/F (Apparent Volume of Distribution During Terminal Phase After Single (First) Oral Administration) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5 | Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose | Participants with a valid pharmacokinetic profile for non compartmental analysis were reported. | L | GEOMETRIC_MEAN |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group138
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
AUC(0-tlast) [Area Under the Concentration-time Curve After Single (First) Dose From Time Zero to the Last Data Point >LLOQ (Lower Limit of Quantification)] for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5 | Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment | Regorafenib | 67.2 | Geometric Coefficient of Variation 45.5 | mg*h/L |
AUC(0-tlast) [Area Under the Concentration-time Curve After Single (First) Dose From Time Zero to the Last Data Point >LLOQ (Lower Limit of Quantification)] for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5 | Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment | Regorafenib | 76.6 | Geometric Coefficient of Variation 50.3 | mg*h/L |
AUC(0-tlast) [Area Under the Concentration-time Curve After Single (First) Dose From Time Zero to the Last Data Point >LLOQ (Lower Limit of Quantification)] for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5 | Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment | Regorafenib metabolites M-2 | 27.8 | Geometric Coefficient of Variation 80.4 | mg*h/L |
AUC(0-tlast) [Area Under the Concentration-time Curve After Single (First) Dose From Time Zero to the Last Data Point >LLOQ (Lower Limit of Quantification)] for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5 | Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment | Regorafenib metabolites M-2 | 19.0 | Geometric Coefficient of Variation 58.7 | mg*h/L |
AUC(0-tlast) [Area Under the Concentration-time Curve After Single (First) Dose From Time Zero to the Last Data Point >LLOQ (Lower Limit of Quantification)] for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5 | Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment | Regorafenib metabolites M-5 | 5.25 | Geometric Coefficient of Variation 145 | mg*h/L |
AUC(0-tlast) [Area Under the Concentration-time Curve After Single (First) Dose From Time Zero to the Last Data Point >LLOQ (Lower Limit of Quantification)] for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5 | Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment | Regorafenib metabolites M-5 | 2.34 | Geometric Coefficient of Variation 79.8 | mg*h/L |
| AE,ur(0-24) (Amount of Drug Excreted Via Urine During the Collection Interval 0-24 Hours Post Administration) for Metabolites M-7 and M-8 | Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment | Regorafenib metabolites M-7 | 3.607 | Standard Deviation 1.124 | percentage of dose |
| AE,ur(0-24) (Amount of Drug Excreted Via Urine During the Collection Interval 0-24 Hours Post Administration) for Metabolites M-7 and M-8 | Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment | Regorafenib metabolites M-7 | 1.309 | Standard Deviation 0.649 | percentage of dose |
| AE,ur(0-24) (Amount of Drug Excreted Via Urine During the Collection Interval 0-24 Hours Post Administration) for Metabolites M-7 and M-8 | Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment | Regorafenib metabolites M-8 | 1.120 | Standard Deviation 0.737 | percentage of dose |
| AE,ur(0-24) (Amount of Drug Excreted Via Urine During the Collection Interval 0-24 Hours Post Administration) for Metabolites M-7 and M-8 | Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment | Regorafenib metabolites M-8 | 0.184 | Standard Deviation 0.229 | percentage of dose |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment | 18 | |
| Overall Study | STARTED | Regorafenib (Stivarga, BAY73-4506)-Severe Renal Impairment | 6 | |
| Overall Study | Received Treatment | Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment | 18 | |
| Overall Study | Received Treatment | Regorafenib (Stivarga, BAY73-4506)-Severe Renal Impairment | 6 | |
| Overall Study | COMPLETED | Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment | 0 | |
| Overall Study | COMPLETED | Regorafenib (Stivarga, BAY73-4506)-Severe Renal Impairment | 0 | |
| Overall Study | NOT COMPLETED | Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment | 18 | |
| Overall Study | NOT COMPLETED | Regorafenib (Stivarga, BAY73-4506)-Severe Renal Impairment | 6 |
Source ClinicalTrials.gov
Adverse events330
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Impairment | 2 | 18 | 6 |
| other | Anaemia | Blood and lymphatic system disorders | Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment | 2 | 6 | 5 |
| other | Neutropenia | Blood and lymphatic system disorders | Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Impairment | 1 | 18 | 2 |
| other | Neutropenia | Blood and lymphatic system disorders | Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment | 0 | 6 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Impairment | 1 | 18 | 1 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment | 2 | 6 | 3 |
| other | Angina pectoris | Cardiac disorders | Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Impairment | 1 | 18 | 1 |
| other | Angina pectoris | Cardiac disorders | Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment | 0 | 6 | 0 |
| other | Tachycardia | Cardiac disorders | Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Impairment | 2 | 18 | 2 |
| other | Tachycardia | Cardiac disorders | Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment | 0 | 6 | 0 |
1 to 10 of 330Source ClinicalTrials.gov
See all 330 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Impairment | ||
| Total, all-cause mortality | Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment | ||
| Total, other adverse events | Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Impairment | 18 | 18 |
| Total, other adverse events | Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment | 6 | 6 |
| Total, serious adverse events | Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Impairment | 9 | 18 |
| Total, serious adverse events | Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment | 2 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Impairment vs Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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Read this trial from software.
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