Trial Outcomes & Findings for BI 6727 (Volasertib) Human ADME Trial in Various Solid Tumours (NCT NCT01145885)
NCT ID: NCT01145885
Last Updated: 2019-01-31
Results Overview
Individual time course profiles of 14C-radioactivity in whole blood and plasma: Cmax of 14C labelled Volasertib.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
7 participants
Primary outcome timeframe
Whole blood: Pre-dose (-0.5 hours (h)) and 1.0h, 1.983h, 4h, 6h, 8h and 24h after start of the 2h drug infusion.Plasma: Pre-dose (-0.5h) and 1.0h, 1.983h, 4h, 6h, 8h, 24h,48h. 96h, 168h and 336h after start of drug infusion.
Results posted on
2019-01-31
Participant Flow
All participants entered the first treatment cycle, if they experienced clinical benefit from the first treatment course they could continue into further treatment courses.
Participant milestones
| Measure |
Volasertib
Participants received 300mg 14C volasertib ((14C) BI 6727) as a single dose via intravenous infusion on day 1 of the the first treatment cycle (21 days).
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Volasertib
Participants received 300mg 14C volasertib ((14C) BI 6727) as a single dose via intravenous infusion on day 1 of the the first treatment cycle (21 days).
|
|---|---|
|
Overall Study
Progressive Disease
|
7
|
Baseline Characteristics
BI 6727 (Volasertib) Human ADME Trial in Various Solid Tumours
Baseline characteristics by cohort
| Measure |
Volasertib
n=7 Participants
Participants received 300mg 14C volasertib ((14C) BI 6727) as a single dose via intravenous infusion on day 1 of the the first treatment cycle (21 days).
|
|---|---|
|
Age, Continuous
|
60.9 Years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Whole blood: Pre-dose (-0.5 hours (h)) and 1.0h, 1.983h, 4h, 6h, 8h and 24h after start of the 2h drug infusion.Plasma: Pre-dose (-0.5h) and 1.0h, 1.983h, 4h, 6h, 8h, 24h,48h. 96h, 168h and 336h after start of drug infusion.Population: Pharmacokinetic (PK) set which included all evaluable patients in the treated set who provided at least 1 observation for at least 1 primary PK endpoint and did not undergo important protocol violations relevant to the evaluation of PK parameters.
Individual time course profiles of 14C-radioactivity in whole blood and plasma: Cmax of 14C labelled Volasertib.
Outcome measures
| Measure |
Volasertib 14C 300 mg
n=6 Participants
Participants received 300mg 14C volasertib ((14C) BI 6727) as a single dose via intravenous infusion on day 1 of the the first treatment cycle (21 days).
|
Volasertib 300mg
Participants received 300mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
Volasertib 250mg
Participants received 250mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
|---|---|---|---|
|
Individual Time Course Profiles of 14C-radioactivity in Whole Blood and Plasma: Cmax of 14C Labelled Volasertib
Whole Blood
|
1746 nmol/L
Geometric Coefficient of Variation 18.0
|
—
|
—
|
|
Individual Time Course Profiles of 14C-radioactivity in Whole Blood and Plasma: Cmax of 14C Labelled Volasertib
Plasma
|
1150 nmol/L
Geometric Coefficient of Variation 14.7
|
—
|
—
|
PRIMARY outcome
Timeframe: Every 24 hours, up to 504 hoursPopulation: PK set
Percentage of administered dose excreted in urine as 14C-radioactivity over time
Outcome measures
| Measure |
Volasertib 14C 300 mg
n=6 Participants
Participants received 300mg 14C volasertib ((14C) BI 6727) as a single dose via intravenous infusion on day 1 of the the first treatment cycle (21 days).
|
Volasertib 300mg
Participants received 300mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
Volasertib 250mg
Participants received 250mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
|---|---|---|---|
|
Individual Time Course Profiles of 14C-radioactivity in Urine: Cumulative Fraction of 14C-ratioactivity Excreted in Urine
0-24 hours
|
4.21 Percentage of dose
Geometric Coefficient of Variation 33.8
|
—
|
—
|
|
Individual Time Course Profiles of 14C-radioactivity in Urine: Cumulative Fraction of 14C-ratioactivity Excreted in Urine
0-168 hours
|
11.7 Percentage of dose
Geometric Coefficient of Variation 23.9
|
—
|
—
|
|
Individual Time Course Profiles of 14C-radioactivity in Urine: Cumulative Fraction of 14C-ratioactivity Excreted in Urine
0-336 hours
|
15.6 Percentage of dose
Geometric Coefficient of Variation 22.5
|
—
|
—
|
|
Individual Time Course Profiles of 14C-radioactivity in Urine: Cumulative Fraction of 14C-ratioactivity Excreted in Urine
0-504 hours
|
18.1 Percentage of dose
Geometric Coefficient of Variation 21.9
|
—
|
—
|
PRIMARY outcome
Timeframe: Every 24 hours, up to 504 hoursPopulation: PK set
Percentage of administered dose excreted in faeces as 14C-radioactivity over time
Outcome measures
| Measure |
Volasertib 14C 300 mg
n=6 Participants
Participants received 300mg 14C volasertib ((14C) BI 6727) as a single dose via intravenous infusion on day 1 of the the first treatment cycle (21 days).
|
Volasertib 300mg
Participants received 300mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
Volasertib 250mg
Participants received 250mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
|---|---|---|---|
|
Individual Time Course Profiles of 14C-radioactivity in Faeces: Cumulative Fraction of 14C-radioactivity Excreted in Faeces
0-24 hours
|
0.680 Percentage of dose
Geometric Coefficient of Variation 433
|
—
|
—
|
|
Individual Time Course Profiles of 14C-radioactivity in Faeces: Cumulative Fraction of 14C-radioactivity Excreted in Faeces
0-168 hours
|
24.4 Percentage of dose
Geometric Coefficient of Variation 46.2
|
—
|
—
|
|
Individual Time Course Profiles of 14C-radioactivity in Faeces: Cumulative Fraction of 14C-radioactivity Excreted in Faeces
0-336 hours
|
36.7 Percentage of dose
Geometric Coefficient of Variation 33.0
|
—
|
—
|
|
Individual Time Course Profiles of 14C-radioactivity in Faeces: Cumulative Fraction of 14C-radioactivity Excreted in Faeces
0-504 hours
|
42.5 Percentage of dose
Geometric Coefficient of Variation 29.3
|
—
|
—
|
PRIMARY outcome
Timeframe: Plasma: Pre-dose (-0.5h) and 1.0h, 1.983h, 4h, 6h, 8h, 24h,48h. 96h, 168h and 336h after start of drug infusion.Population: PK set
Individual time course profiles of volasertib (BI 6727) and a metabolite of volasertib (CD 10899), in plasma: Cmax of Volasertib and CD 10899.
Outcome measures
| Measure |
Volasertib 14C 300 mg
n=6 Participants
Participants received 300mg 14C volasertib ((14C) BI 6727) as a single dose via intravenous infusion on day 1 of the the first treatment cycle (21 days).
|
Volasertib 300mg
Participants received 300mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
Volasertib 250mg
Participants received 250mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
|---|---|---|---|
|
Individual Time Course Profiles of Volasertib and CD 10899 in Plasma: Cmax of Volasertib and CD 10899 (a Metabolite of Volasertib).
Volasertib (1.983 hours)
|
926 nmol/L
Geometric Coefficient of Variation 17.8
|
—
|
—
|
|
Individual Time Course Profiles of Volasertib and CD 10899 in Plasma: Cmax of Volasertib and CD 10899 (a Metabolite of Volasertib).
CD 10899 (6 hours)
|
9.92 nmol/L
Geometric Coefficient of Variation 29.8
|
—
|
—
|
PRIMARY outcome
Timeframe: Every 24 hours, up to 504 hoursPopulation: PK set
Percentage of administered dose excreted in urine as volasertib (BI 6727) over time
Outcome measures
| Measure |
Volasertib 14C 300 mg
n=6 Participants
Participants received 300mg 14C volasertib ((14C) BI 6727) as a single dose via intravenous infusion on day 1 of the the first treatment cycle (21 days).
|
Volasertib 300mg
Participants received 300mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
Volasertib 250mg
Participants received 250mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
|---|---|---|---|
|
Individual Time Course Profile of Volasertib in Urine:Cumulative Fraction of Volasertib Excreted in Urine
0-24 hours
|
3.24 Percentage of dose
Geometric Coefficient of Variation 31.6
|
—
|
—
|
|
Individual Time Course Profile of Volasertib in Urine:Cumulative Fraction of Volasertib Excreted in Urine
0-168 hours
|
7.57 Percentage of dose
Geometric Coefficient of Variation 28.4
|
—
|
—
|
|
Individual Time Course Profile of Volasertib in Urine:Cumulative Fraction of Volasertib Excreted in Urine
0-336 hours
|
9.14 Percentage of dose
Geometric Coefficient of Variation 28.7
|
—
|
—
|
|
Individual Time Course Profile of Volasertib in Urine:Cumulative Fraction of Volasertib Excreted in Urine
0-504 hours
|
9.89 Percentage of dose
Geometric Coefficient of Variation 29.2
|
—
|
—
|
PRIMARY outcome
Timeframe: Every 24 hours, up to 504 hoursPopulation: PK set
Cumulative amounts of CD 10899, a metabolite of volasertib, excreted in urine over time
Outcome measures
| Measure |
Volasertib 14C 300 mg
n=6 Participants
Participants received 300mg 14C volasertib ((14C) BI 6727) as a single dose via intravenous infusion on day 1 of the the first treatment cycle (21 days).
|
Volasertib 300mg
Participants received 300mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
Volasertib 250mg
Participants received 250mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
|---|---|---|---|
|
Individual Time Course Profile of CD 10899 in Urine: Cumulative Amount of CD 10899 Excreted in Urine
0-24 hours
|
1240 nmol
Geometric Coefficient of Variation 54.9
|
—
|
—
|
|
Individual Time Course Profile of CD 10899 in Urine: Cumulative Amount of CD 10899 Excreted in Urine
0-168 hours
|
5670 nmol
Geometric Coefficient of Variation 37.3
|
—
|
—
|
|
Individual Time Course Profile of CD 10899 in Urine: Cumulative Amount of CD 10899 Excreted in Urine
0-336 hours
|
7580 nmol
Geometric Coefficient of Variation 34.4
|
—
|
—
|
|
Individual Time Course Profile of CD 10899 in Urine: Cumulative Amount of CD 10899 Excreted in Urine
0-504 hours
|
8490 nmol
Geometric Coefficient of Variation 33.6
|
—
|
—
|
PRIMARY outcome
Timeframe: up to 504 hoursPopulation: PK set
Cumulative Percentage of 14C-radioactivity excreted in urine and faeces at 504 hours after start of drug infusion related to total \[14C\] volasertib administered.
Outcome measures
| Measure |
Volasertib 14C 300 mg
n=6 Participants
Participants received 300mg 14C volasertib ((14C) BI 6727) as a single dose via intravenous infusion on day 1 of the the first treatment cycle (21 days).
|
Volasertib 300mg
Participants received 300mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
Volasertib 250mg
Participants received 250mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
|---|---|---|---|
|
Rate and Extent of Excretion Mass Balance Based on the Total Radioactivity in Urine and Faeces: Cumulative Fraction of Excretion 504 Hours After Start of Drug Infusion.
Urine
|
18.1 Percentage of dose
Geometric Coefficient of Variation 21.9
|
—
|
—
|
|
Rate and Extent of Excretion Mass Balance Based on the Total Radioactivity in Urine and Faeces: Cumulative Fraction of Excretion 504 Hours After Start of Drug Infusion.
Faeces
|
42.5 Percentage of dose
Geometric Coefficient of Variation 29.3
|
—
|
—
|
PRIMARY outcome
Timeframe: 30 minutes (min) before start of infusion and 1 hour (h), 1h 59min, 4h, 6h, 8h, 24h, 48h, 96h, 168h and 336h after start of infusionPopulation: PK set
Maximum measured concentration of volasertib and CD 10899, a metabolite of volasertib, in plasma (Cmax).
Outcome measures
| Measure |
Volasertib 14C 300 mg
n=6 Participants
Participants received 300mg 14C volasertib ((14C) BI 6727) as a single dose via intravenous infusion on day 1 of the the first treatment cycle (21 days).
|
Volasertib 300mg
Participants received 300mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
Volasertib 250mg
Participants received 250mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
|---|---|---|---|
|
Cmax of Volasertib and CD 10899 in Plasma
Volasertib
|
926 nmol/L
Geometric Coefficient of Variation 17.8
|
—
|
—
|
|
Cmax of Volasertib and CD 10899 in Plasma
CD 10899
|
11.1 nmol/L
Geometric Coefficient of Variation 24.5
|
—
|
—
|
PRIMARY outcome
Timeframe: 30 minutes (min) before start of infusion and 1 hour (h), 1h 59min, 4h, 6h, 8h, 24h, 48h, 96h, 168h and 336h after start of infusionPopulation: PK set
Area under the concentration-time curve of volasertib and CD 10899, a metabolite of volasertib, in plasma over the time interval from 0 to infinity (AUC0-inf).
Outcome measures
| Measure |
Volasertib 14C 300 mg
n=6 Participants
Participants received 300mg 14C volasertib ((14C) BI 6727) as a single dose via intravenous infusion on day 1 of the the first treatment cycle (21 days).
|
Volasertib 300mg
Participants received 300mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
Volasertib 250mg
Participants received 250mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
|---|---|---|---|
|
AUC0-inf of Volasertib and CD10899 in Plasma
Volasertib
|
11400 nmol*h/L
Geometric Coefficient of Variation 22.3
|
—
|
—
|
|
AUC0-inf of Volasertib and CD10899 in Plasma
CD 10899
|
1500 nmol*h/L
Geometric Coefficient of Variation 16.8
|
—
|
—
|
PRIMARY outcome
Timeframe: Every 24 hours, up to 504 hoursPopulation: PK set
Renal clearance of the analyte in urine (CL/R) within the time interval 0 hours to 504 hours of volasertib and CD 10899, a metabolite of volasertib.
Outcome measures
| Measure |
Volasertib 14C 300 mg
n=6 Participants
Participants received 300mg 14C volasertib ((14C) BI 6727) as a single dose via intravenous infusion on day 1 of the the first treatment cycle (21 days).
|
Volasertib 300mg
Participants received 300mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
Volasertib 250mg
Participants received 250mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
|---|---|---|---|
|
CL/R of Volasertib and CD 10899 in Urine
Volasertib
|
68.5 mL/min
Geometric Coefficient of Variation 23.2
|
—
|
—
|
|
CL/R of Volasertib and CD 10899 in Urine
CD 10899
|
102 mL/min
Geometric Coefficient of Variation 26.8
|
—
|
—
|
PRIMARY outcome
Timeframe: Every 24 hours, up to 504 hoursPopulation: PK set
Amount of analyte eliminated in urine within the time interval 0 hours to last quantifiable data point (Ae(0-tz)) for volasertib and CD 10899, a metabolite of volasertib.
Outcome measures
| Measure |
Volasertib 14C 300 mg
n=6 Participants
Participants received 300mg 14C volasertib ((14C) BI 6727) as a single dose via intravenous infusion on day 1 of the the first treatment cycle (21 days).
|
Volasertib 300mg
Participants received 300mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
Volasertib 250mg
Participants received 250mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
|---|---|---|---|
|
Ae(0-tz) of Volasertib and CD 10899 in Urine
CD 10899
|
8490 nmol
Geometric Coefficient of Variation 33.6
|
—
|
—
|
|
Ae(0-tz) of Volasertib and CD 10899 in Urine
Volasertib
|
45800 nmol
Geometric Coefficient of Variation 29.3
|
—
|
—
|
PRIMARY outcome
Timeframe: 30 minutes (min) before start of infusion and 1 hour (h), 1h 59min, 4h, 6h, 8h, 24h, 48h, 96h, 168h and 336h after start of infusion for plasma; 30 min before start of infusion and 1h, 1h 59min, 4h, 6h, 8h and 24h after start of infusion for whole bloodPopulation: PK set
Area under the concentration-time curve of 14C radioactivity in plasma and whole blood over the time interval from 0 to the last quantifiable data point (AUC0-tz).
Outcome measures
| Measure |
Volasertib 14C 300 mg
n=6 Participants
Participants received 300mg 14C volasertib ((14C) BI 6727) as a single dose via intravenous infusion on day 1 of the the first treatment cycle (21 days).
|
Volasertib 300mg
Participants received 300mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
Volasertib 250mg
Participants received 250mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
|---|---|---|---|
|
AUC0-tz of 14C Radioactivity in Plasma and Whole Blood
Plasma
|
4450 nmol*h/L
Geometric Coefficient of Variation 57.6
|
—
|
—
|
|
AUC0-tz of 14C Radioactivity in Plasma and Whole Blood
Whole blood
|
8810 nmol*h/L
Geometric Coefficient of Variation 26.5
|
—
|
—
|
PRIMARY outcome
Timeframe: Every 24 hours, up to 504 hoursPopulation: PK set
Amount of analyte eliminated in urine within the time interval 0 to to the last quantifiable data point (Ae(0-tz)) of 14C radioactivity
Outcome measures
| Measure |
Volasertib 14C 300 mg
n=6 Participants
Participants received 300mg 14C volasertib ((14C) BI 6727) as a single dose via intravenous infusion on day 1 of the the first treatment cycle (21 days).
|
Volasertib 300mg
Participants received 300mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
Volasertib 250mg
Participants received 250mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
|---|---|---|---|
|
Ae(0-tz) of 14C Radioactivity in Urine
|
84000 nmol
Geometric Coefficient of Variation 22.1
|
—
|
—
|
PRIMARY outcome
Timeframe: Every 24 hours, up to 504 hoursPopulation: PK set
Amount of analyte excreted in faeces within the time interval 0 to to the last quantifiable data point (Ae(0-tz)) of 14C radioactivity
Outcome measures
| Measure |
Volasertib 14C 300 mg
n=6 Participants
Participants received 300mg 14C volasertib ((14C) BI 6727) as a single dose via intravenous infusion on day 1 of the the first treatment cycle (21 days).
|
Volasertib 300mg
Participants received 300mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
Volasertib 250mg
Participants received 250mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
|---|---|---|---|
|
Ae,Faeces(0-tz) of 14C Radioactivity
|
197000 nmol
Geometric Coefficient of Variation 29.1
|
—
|
—
|
PRIMARY outcome
Timeframe: 1.983 hours and 6 hoursPopulation: PK set
Time dependency of Cblood cells/Cplasma ratio and Cblood/Cplasma ratio of 14C-radioactivity.
Outcome measures
| Measure |
Volasertib 14C 300 mg
n=6 Participants
Participants received 300mg 14C volasertib ((14C) BI 6727) as a single dose via intravenous infusion on day 1 of the the first treatment cycle (21 days).
|
Volasertib 300mg
Participants received 300mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
Volasertib 250mg
Participants received 250mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
|---|---|---|---|
|
Time Dependency of Cblood Cells/Cplasma Ratio and Cblood/Cplasma Ratio of 14C-radioactivity
Cblood/Cplasma ratio: 1.983 hours
|
1.52 Ratio
Geometric Coefficient of Variation 9.67
|
—
|
—
|
|
Time Dependency of Cblood Cells/Cplasma Ratio and Cblood/Cplasma Ratio of 14C-radioactivity
Cblood/Cplasma ratio: 6 hours
|
1.54 Ratio
Geometric Coefficient of Variation 9.30
|
—
|
—
|
|
Time Dependency of Cblood Cells/Cplasma Ratio and Cblood/Cplasma Ratio of 14C-radioactivity
Cblood cells/Cplasma ratio: 1.983 hours
|
2.66 Ratio
Geometric Coefficient of Variation 13.8
|
—
|
—
|
|
Time Dependency of Cblood Cells/Cplasma Ratio and Cblood/Cplasma Ratio of 14C-radioactivity
Cblood cells/Cplasma ratio: 6 hours
|
2.76 Ratio
Geometric Coefficient of Variation 18.8
|
—
|
—
|
PRIMARY outcome
Timeframe: 3 weeksPopulation: This endpoint was not analyzed. Please refer to the description for the explanation.
Elucidation of mb structures and identification of major metabolites in plasma, urine, and faeces. This endpoint was not analysed in the study report. The contribution of volasertib and the metabolite CD 10899 to total radioactivity in plasma in the time interval 0 to 8 h after drug administration supports the suggestion that other metabolites in addition to CD 10899 are present in plasma. However, different methods used for the quantification of volasertib and CD 10899 (HPLC MS/MS) and total 14C-radioactivity (liquid scintillation counting) have to be taken into account for the interpretation of the difference between total 14C-radioactivity and analysis of volasertib and CD 10899 in plasma and the plasma metabolite pattern remains to be categorized.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first intake of study drug until 21 days after last intake of the study drug, up to 63 daysPopulation: Treated set
Percentage of participants with drug related adverse events (AEs)
Outcome measures
| Measure |
Volasertib 14C 300 mg
n=7 Participants
Participants received 300mg 14C volasertib ((14C) BI 6727) as a single dose via intravenous infusion on day 1 of the the first treatment cycle (21 days).
|
Volasertib 300mg
n=3 Participants
Participants received 300mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
Volasertib 250mg
n=2 Participants
Participants received 250mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
|---|---|---|---|
|
Percentage of Participants With Drug Related Adverse Events
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From first intake of study drug until 21 days after last intake of the study drug, up to 63 daysPopulation: Treated set
Percentage of participants with clinically relevant abnormalities for clinical assessments, electrocardiogram (ECG), vital signs and clinical laboratory test parameters. New abnormal findings or worsening of baseline conditions were reported as adverse events.
Outcome measures
| Measure |
Volasertib 14C 300 mg
n=7 Participants
Participants received 300mg 14C volasertib ((14C) BI 6727) as a single dose via intravenous infusion on day 1 of the the first treatment cycle (21 days).
|
Volasertib 300mg
n=3 Participants
Participants received 300mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
Volasertib 250mg
n=2 Participants
Participants received 250mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
|---|---|---|---|
|
Percentage of Participants With Clinically Relevant Abnormalities for Clinical Assessments, ECG, Vital Signs and Laboratory Tests
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: 21, 42 and 63 daysPopulation: Treated set
The endpoint tumour response was was analysed as the percentage of participants with clinical benefit after each treatment cycle based on the Investigator's response assessment (with clinical assessment being conducted after every cycle and radiological assessment at the Investigator's discretion).
Outcome measures
| Measure |
Volasertib 14C 300 mg
n=7 Participants
Participants received 300mg 14C volasertib ((14C) BI 6727) as a single dose via intravenous infusion on day 1 of the the first treatment cycle (21 days).
|
Volasertib 300mg
n=3 Participants
Participants received 300mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
Volasertib 250mg
n=2 Participants
Participants received 250mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
|---|---|---|---|
|
Percentage of Participants With Clinical Benefit
End of cycle 1 (21 days): Clinical Benefit=No
|
42.9 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Clinical Benefit
End of cycle 1 (21 days): Clinical Benefit=Yes
|
57.1 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Clinical Benefit
End of cycle 2 (42 days): Clinical Benefit=No
|
0.0 Percentage of participants
|
66.7 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants With Clinical Benefit
End of cycle 2 (42 days): Clinical Benefit=Yes
|
0.0 Percentage of participants
|
33.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Clinical Benefit
End of cycle 3 (63 days): Clinical Benefit=No
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants With Clinical Benefit
End of cycle 3 (63 days): Clinical Benefit=Yes
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
Adverse Events
Volasertib 14C 300mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Volasertib 300mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Total_Volasertib 300
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Volasertib 250mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Volasertib
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Volasertib 14C 300mg
n=7 participants at risk
Participants received 300mg 14C volasertib ((14C) BI 6727) as a single dose via intravenous infusion on day 1 of the the first treatment cycle (21 days).
|
Volasertib 300mg
n=3 participants at risk
Participants received 300mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
Total_Volasertib 300
n=7 participants at risk
Participants received 300mg 14C volasertib ((14C) BI 6727) as a single dose via intravenous infusion on day 1 of the the first treatment cycle (21 days) and patient who continued into further treatment cycles and received 300mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle.
|
Volasertib 250mg
n=2 participants at risk
Participants received 300mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
Volasertib
n=7 participants at risk
Participants received 300mg 14C volasertib ((14C) BI 6727) as a single dose via intravenous infusion on day 1 of the the first treatment cycle (21 days).
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
33.3%
1/3 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
14.3%
1/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
0.00%
0/2 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
14.3%
1/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
Other adverse events
| Measure |
Volasertib 14C 300mg
n=7 participants at risk
Participants received 300mg 14C volasertib ((14C) BI 6727) as a single dose via intravenous infusion on day 1 of the the first treatment cycle (21 days).
|
Volasertib 300mg
n=3 participants at risk
Participants received 300mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
Total_Volasertib 300
n=7 participants at risk
Participants received 300mg 14C volasertib ((14C) BI 6727) as a single dose via intravenous infusion on day 1 of the the first treatment cycle (21 days) and patient who continued into further treatment cycles and received 300mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle.
|
Volasertib 250mg
n=2 participants at risk
Participants received 300mg non-radiolabelled volasertib (BI 6727) via intravenous infusion on day 1 of each 21-day treatment cycle, in treatment cycles 2 or 3.
|
Volasertib
n=7 participants at risk
Participants received 300mg 14C volasertib ((14C) BI 6727) as a single dose via intravenous infusion on day 1 of the the first treatment cycle (21 days).
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
57.1%
4/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
100.0%
3/3 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
71.4%
5/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
50.0%
1/2 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
71.4%
5/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
|
Blood and lymphatic system disorders
Leukopenia
|
71.4%
5/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
100.0%
3/3 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
85.7%
6/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
100.0%
2/2 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
85.7%
6/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
|
Blood and lymphatic system disorders
Neutropenia
|
42.9%
3/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
100.0%
3/3 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
57.1%
4/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
50.0%
1/2 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
57.1%
4/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
85.7%
6/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
100.0%
3/3 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
85.7%
6/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
100.0%
2/2 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
85.7%
6/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
|
Eye disorders
Vision blurred
|
0.00%
0/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
33.3%
1/3 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
14.3%
1/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
0.00%
0/2 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
14.3%
1/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.3%
1/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
33.3%
1/3 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
28.6%
2/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
0.00%
0/2 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
28.6%
2/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
0.00%
0/3 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
14.3%
1/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
0.00%
0/2 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
14.3%
1/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
|
General disorders
Oedema peripheral
|
0.00%
0/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
33.3%
1/3 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
14.3%
1/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
0.00%
0/2 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
14.3%
1/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
14.3%
1/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
33.3%
1/3 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
14.3%
1/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
0.00%
0/2 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
14.3%
1/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
0.00%
0/3 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
14.3%
1/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
0.00%
0/2 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
14.3%
1/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
33.3%
1/3 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
14.3%
1/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
0.00%
0/2 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
14.3%
1/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
14.3%
1/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
0.00%
0/3 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
14.3%
1/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
0.00%
0/2 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
14.3%
1/7 • From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER