A Phase 1 interventional study of BI 6727 in Neoplasms, sponsored by Boehringer Ingelheim. Completed at 2 sites in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-26.
Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment
The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI 6727 in Asian cancer patients, and to provide safety data in terms of drug-related adverse events.
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Exclusion criteria:
Schedule A
Drug: BI 6727
Dose level 1
Percentage of Participants With Dose Limiting Toxicities (DLT) in Cycle 1 for the Determination of the Maximum Tolerated Dose (MTD) of Volasertib
Primary objective for this trial was to identify the MTD of volasertib for 2 dosing schedules. The MTD was defined as the highest volasertib dose studied for which the incidence of DLT was less than 2/6 patients. The MTD was defined on the basis of DLTs observed during the first treatment course only. In this outcome measure the percentage of participants with DLTs in cycle 1 is presented.
Time frame: From first administration of study drug up to 3 weeks
MTD of Volasertib
Primary objective for this trial was to identify the MTD of volasertib for 2 dosing schedules. The MTD was defined as the highest volasertib dose studied for which the incidence of DLT was less than 2/6 patients. This outcome measure shows the MTD.
Time frame: From the first administration of study drug up to 3 weeks
Percentage of Participants With Incidence and Intensity of Drug-related AEs According to CTCAE v.3.0
Percentage of participants with incidence and intensity of drug-related AEs according to Common Terminology Criteria for Adverse Events (CTCAE) v.3.0. This endpoint will be presented as a percentage of patients with adverse event by treatment and the highest CTCAE grade of the related AE.
Time frame: From first administration of volasertib to 21 days after the last dose, up to 548 days
Change From Baseline to Last Value on Treatment in Platelets
This endpoint will be presented as a change from baseline to last value on treatment in platelets.
Time frame: Baseline (Visit 1, prior to first administration of volasertib) and up to 21 days after last observation on treatment (up to 548 days)
Change From Baseline to Last Value on Treatment in Neutrophils
This endpoint will be presented as a change from baseline to last value on treatment in neutrophils.
Time frame: Baseline (Visit 1, prior to first administration of volasertib) and up to 21 days after last observation on treatment (up to 548 days)
Patient Performance
This endpoint will present the best clinical assessment. The investigator will perform a clinical assessment. An evaluation will be done whether the patient appears to be clinically improved, unchanged, or deteriorated. The presented numbers show the percentage of patients.
Time frame: From first administration of volasertib to the last dose, up to 527 days
Vital Signs (Blood Pressure)
This endpoint will be presented as a change from baseline at last observation of systolic blood pressure (SBP), diastolic blood pressure (DBP) in millimeter of mercury (mmHg) and pulse rate (PR) in beats per minute (bpm). In this outcome measure SBP and DBP are presented.
Time frame: Baseline (Visit 1, prior to the first administration of volasertib), up to 21 days after last observation on treatment (up to 548 days)
Vital Signs (Pulse Rate)
This endpoint will be presented as a change from baseline at last observation of systolic blood pressure (SBP), diastolic blood pressure (DBP) in millimeter of mercury (mmHg) and pulse rate (PR) in beats per minute (bpm). In this outcome measure the pulse rate is presented.
Time frame: Baseline (Visit 1, prior to the first administration of volasertib), up to 21 days after last observation on treatment (up to 548 days)
ECG
This endpoint will be presented as a change from individual baseline in QT interval, corrected according to Fridericias formula (QTcF) to end of infusion (2 hours) and 24 hours after first infusion in Cycle 1.
Time frame: Baseline, 2 hours (before the end of infusion of volasertib) and 24 hours after first infusion in Cycle 1
Objective Response
The objective response (OR) was defined as complete response (CR; disappearance of all target lesions) or partial response (PR; at least a 30 percent decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest) assessed by tumour measurement and evaluated according to the Response Evaluation Criteria in solid tumours (RECIST), version 1.0. The data represents the percentage of patients.
Time frame: At screening and at the end of every other treatment course up to 527 days (= longest treatment exposure)
Progression-free Survival
Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death. PFS was assessed by tumour measurement and evaluated according to RECIST, version 1.0.
Time frame: At screening and at the end of every other treatment course up to 527 days (= longest treatment exposure)
Response Duration
The duration of overall response was measured from the time measurement criteria were met for complete response (CR) or partial response (PR), whichever was recorded first, until the first date that recurrent or progressive disease was objectively documented. The duration of overall CR was measured from the time measurement criteria were first met for CR until the first date that recurrent disease was objectively documented.
Time frame: From first drug administration up to at 3 month interval after final End of treatment visit until disease progression, death, or lost to follow-up, up to 548 days
Disease Control
The disease control (DC) presented are the percentage of patients with CR, PR or stable disease as best response throughout the study assessed by tumour measurement and evaluated according to RECIST, version 1.0.
Time frame: At screening and at the end of every other treatment course up to 527 days (= longest treatment exposure)
Sum of the Largest Diameters of Target Lesions
The individual time profile of the sum of the largest diameters of target lesions (LD) is presented graphically for each patient in the Clinical Trial Report (CTR) only. No descriptive statistics were planned.
Time frame: At screening and at the end of every other treatment course up to 527 days (= longest treatment exposure)
Pharmacokinetics (PK) AUC0-∞ of Volasertib
The PK of volasertib will be presented for the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) for the population attending the D1 schedule, the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 168 hours (AUC0-168) for the population attending the D1+ D8 schedule and the maximum measured concentration of volasertib in plasma (Cmax). In this outcome measure AUC0-∞ is presented.
Time frame: Both schedules: 10 minutes prior to first drug administration and 1 hour (h), 2, 2:30, 3, 4, 8, 24, 336h thereafter; additional planned times in schedule D1+D8: 167:50, 169, 170, 170:30, 171, 172, 176, 192h; additional planned time in D1 schedule: 168h
Pharmacokinetics (PK) AUC0-168 of Volasertib
The PK of volasertib will be presented for the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) for the population attending the D1 schedule, the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 168 hours (AUC0-168) for the population attending the D1+ D8 schedule and the maximum measured concentration of volasertib in plasma (Cmax). In this outcome measure AUC0-168 is presented.
Time frame: Both schedules: 10 minutes prior to first drug administration and 1 hour (h), 2, 2:30, 3, 4, 8, 24, 336h thereafter; additional planned times in schedule D1+D8: 167:50, 169, 170, 170:30, 171, 172, 176, 192h; additional planned time in D1 schedule: 168h
Pharmacokinetics (PK) Cmax of Volasertib
The PK of volasertib will be presented for the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) for the population attending the D1 schedule, the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 168 hours (AUC0-168) for the population attending the D1+ D8 schedule and the maximum measured concentration of volasertib in plasma (Cmax). In this outcome measure Cmax is presented.
Time frame: Both schedules: 10 minutes prior to first drug administration and 1 hour (h), 2, 2:30, 3, 4, 8, 24, 336h thereafter; additional planned times in schedule D1+D8: 167:50, 169, 170, 170:30, 171, 172, 176, 192h; additional planned time in D1 schedule: 168h
A Phase I single dose escalation study of two dosing schedules of Volasertib administered intravenously in Asian patients with various solid cancers with repeated administration in patients with clinical benefit
| Milestone | V 100 mg D1 | V 200 mg D1 | V 250 mg D1 | V 300 mg D1 | V 350 mg D1 | V 50 mg D1, D8 | V 100 mg D1, D8 | V 150 mg D1, D8 | V 200 mg D1, D8 |
|---|---|---|---|---|---|---|---|---|---|
| Started | 3 | 3 | 6 | 17 | 3 | 4 | 4 | 16 | 3 |
| Completed | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 2 | 0 |
| Not completed | 3 | 3 | 6 | 16 | 3 | 4 | 4 | 14 | 3 |
| Withdrew: Progressive disease (pd) | 2 | 2 | 6 | 9 | 2 | 4 | 2 | 12 | 3 |
| Withdrew: Dose limiting toxicity (dlt) | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Other adverse event | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Refused cont. medication | 1 | 1 | 0 | 2 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Not specified above | 0 | 0 | 0 | 4 | 0 | 0 | 1 | 1 | 0 |
Primary objective for this trial was to identify the MTD of volasertib for 2 dosing schedules. The MTD was defined as the highest volasertib dose studied for which the incidence of DLT was less than 2/6 patients. The MTD was defined on the basis of DLTs observed during the first treatment course only. In this outcome measure the percentage of participants with DLTs in cycle 1 is presented.
| percentage of participants | V100 D1 | V200 D1 | V250 D1 | V300 D1 | V350 D1 | V50 D1, D8 | V100 D1, D8 | V150 D1, D8 | V200 D1, D8 |
|---|---|---|---|---|---|---|---|---|---|
| Percentage of Participants With Dose Limiting Toxicities (DLT) in Cycle 1 for the Determination of the Maximum Tolerated Dose (MTD) of Volasertib | 0.0 | 0.0 | 16.7 | 23.5 | 100 | 0.0 | 0.0 | 0.0 | 66.7 |
Primary objective for this trial was to identify the MTD of volasertib for 2 dosing schedules. The MTD was defined as the highest volasertib dose studied for which the incidence of DLT was less than 2/6 patients. This outcome measure shows the MTD.
| milligram (mg) | Volasertib D1 Schedule | Volasertib D1 and D 8 Schedule |
|---|---|---|
| MTD of Volasertib | 300 | 150 |
Percentage of participants with incidence and intensity of drug-related AEs according to Common Terminology Criteria for Adverse Events (CTCAE) v.3.0. This endpoint will be presented as a percentage of patients with adverse event by treatment and the highest CTCAE grade of the related AE.
| Percentage of participants | V100 D1 | V200 D1 | V250 D1 | V300 D1 | V350 D1 | V50 D1, D8 | V100 D1, D8 | V150 D1, D8 | V200 D1, D8 |
|---|---|---|---|---|---|---|---|---|---|
| CTCAE Grade 1 | 0.0 | 0.0 | 0.0 | 5.9 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| CTCAE Grade 2 | 0.0 | 66.7 | 33.3 | 11.8 | 0.0 | 25.0 | 50.0 | 43.8 | 0.0 |
| CTCAE Grade 3 | 33.3 | 0.0 | 16.7 | 35.3 | 0.0 | 0.0 | 0.0 | 18.8 | 33.3 |
| CTCAE Grade 4 | 0.0 | 0.0 | 33.3 | 29.4 | 100.0 | 0.0 | 0.0 | 6.3 | 66.7 |
| CTCAE Grade 5 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
This endpoint will be presented as a change from baseline to last value on treatment in platelets.
| 10^9 platelets/ Litre (L) | V100 D1 | V200 D1 | V250 D1 | V300 D1 | V350 D1 | V50 D1, D8 | V100 D1, D8 | V150 D1, D8 | V200 D1, D8 |
|---|---|---|---|---|---|---|---|---|---|
| Change From Baseline to Last Value on Treatment in Platelets | -30 ± 48 | -62 ± 30 | -5 ± 114 | -10 ± 173 | -55 ± 150 | -18 ± 29 | -69 ± 29 | -94 ± 111 | 42 ± 119 |
This endpoint will be presented as a change from baseline to last value on treatment in neutrophils.
| 10^9 neutrophils / Litre (L) | V100 D1 | V200 D1 | V250 D1 | V300 D1 | V350 D1 | V50 D1, D8 | V100 D1, D8 | V150 D1, D8 | V200 D1, D8 |
|---|---|---|---|---|---|---|---|---|---|
| Change From Baseline to Last Value on Treatment in Neutrophils | 0.9 ± 3.4 | -1.4 ± 1.1 | -1.3 ± 1.9 | -0.8 ± 3.2 | -0.7 ± 3.2 | 1.3 ± 1.4 | 1.0 ± 4.4 | -1.4 ± 2.6 | 3.1 ± 6.4 |
This endpoint will present the best clinical assessment. The investigator will perform a clinical assessment. An evaluation will be done whether the patient appears to be clinically improved, unchanged, or deteriorated. The presented numbers show the percentage of patients.
| percentage of participants | V100 D1 | V200 D1 | V250 D1 | V300 D1 | V350 D1 | V50 D1, D8 | V100 D1, D8 | V150 D1, D8 | V200 D1, D8 |
|---|---|---|---|---|---|---|---|---|---|
| Unknown | 0 ± 48 | 0 ± 30 | 0 ± 114 | 6 ± 173 | 0 ± 150 | 0 ± 29 | 0 ± 29 | 0 ± 111 | 0 ± 119 |
| Improved | 0 | 0 | 0 | 6 | 67 | 25 | 0 | 13 | 0 |
| Unchanged | 100 | 100 | 100 | 88 | 33 | 50 | 75 | 81 | 100 |
| Deteriorated | 0 | 0 | 0 | 0 | 0 | 25 | 25 | 6 | 0 |
This endpoint will be presented as a change from baseline at last observation of systolic blood pressure (SBP), diastolic blood pressure (DBP) in millimeter of mercury (mmHg) and pulse rate (PR) in beats per minute (bpm). In this outcome measure SBP and DBP are presented.
| mmHg | V100 D1 | V200 D1 | V250 D1 | V300 D1 | V350 D1 | V50 D1, D8 | V100 D1, D8 | V150 D1, D8 | V200 D1, D8 |
|---|---|---|---|---|---|---|---|---|---|
| SBP, chg from baseline at last observation | -19.0 ± 19.5 | 4.7 ± 14.2 | 0.0 ± 8.3 | -1.0 ± 19.1 | -12.3 ± 10.8 | 6.0 ± 12.7 | 1.5 ± 11.0 | -8.9 ± 16.9 | -3.3 ± 7.6 |
| DBP, chg from baseline at last observation | -4.0 ± 9.0 | 2.0 ± 5.0 | -1.3 ± 11.3 | -1.9 ± 11.3 | -7.7 ± 10.0 | 10.3 ± 9.0 | 2.3 ± 10.4 | -2.9 ± 8.2 | 1.0 ± 6.2 |
This endpoint will be presented as a change from baseline at last observation of systolic blood pressure (SBP), diastolic blood pressure (DBP) in millimeter of mercury (mmHg) and pulse rate (PR) in beats per minute (bpm). In this outcome measure the pulse rate is presented.
| bpm | V100 D1 | V200 D1 | V250 D1 | V300 D1 | V350 D1 | V50 D1, D8 | V100 D1, D8 | V150 D1, D8 | V200 D1, D8 |
|---|---|---|---|---|---|---|---|---|---|
| Vital Signs (Pulse Rate) | 18.3 ± 10.3 | 9.7 ± 15.5 | 16.5 ± 5.8 | 10.4 ± 16.5 | 2.7 ± 12.1 | 13.5 ± 7.0 | 10.0 ± 5.0 | 5.1 ± 18.9 | 12.7 ± 8.5 |
This endpoint will be presented as a change from individual baseline in QT interval, corrected according to Fridericias formula (QTcF) to end of infusion (2 hours) and 24 hours after first infusion in Cycle 1.
| milliseconds (ms) | V300 D1 | V150 D1, D8 |
|---|---|---|
| Change from baseline after 2 hours | 21.0 ± 10.6 | 13.9 ± 7.7 |
| Change from baseline after 24 hours | 5.2 ± 10.4 | 6.3 ± 9.7 |
The objective response (OR) was defined as complete response (CR; disappearance of all target lesions) or partial response (PR; at least a 30 percent decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest) assessed by tumour measurement and evaluated according to the Response Evaluation Criteria in solid tumours (RECIST), version 1.0. The data represents the percentage of patients.
| percentage of patients | V100 D1 | V200 D1 | V250 D1 | V300 D1 | V350 D1 | V50 D1, D8 | V100 D1, D8 | V150 D1, D8 | V200 D1, D8 |
|---|---|---|---|---|---|---|---|---|---|
| OR: no or unknown | 100 | 100 | 100 | 100 | 67 | 100 | 100 | 94 | 100 |
| OR: yes | 0 | 0 | 0 | 0 | 33 | 0 | 0 | 6 | 0 |
Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death. PFS was assessed by tumour measurement and evaluated according to RECIST, version 1.0.
| days | V100 D1 | V200 D1 | V250 D1 | V300 D1 | V350 D1 | V50 D1, D8 | V100 D1, D8 | V150 D1, D8 | V200 D1, D8 |
|---|---|---|---|---|---|---|---|---|---|
| Progression-free Survival | 83.0 (48 to 211) | 62.0 (37 to 84) | 48.0 (43 to 82) | 49.0 (30 to 139) | 274.0 (49 to 274) | 42.5 (8 to 254) | 92.0 (8 to 267) | 58.0 (8 to 499) | 45.0 (43 to 56) |
The duration of overall response was measured from the time measurement criteria were met for complete response (CR) or partial response (PR), whichever was recorded first, until the first date that recurrent or progressive disease was objectively documented. The duration of overall CR was measured from the time measurement criteria were first met for CR until the first date that recurrent disease was objectively documented.
No measurements were reported for this outcome.
The disease control (DC) presented are the percentage of patients with CR, PR or stable disease as best response throughout the study assessed by tumour measurement and evaluated according to RECIST, version 1.0.
| percentage of patients | V100 D1 | V200 D1 | V250 D1 | V300 D1 | V350 D1 | V50 D1, D8 | V100 D1, D8 | V150 D1, D8 | V200 D1, D8 |
|---|---|---|---|---|---|---|---|---|---|
| DC: no or unknown | 33 | 33 | 67 | 59 | 33 | 75 | 50 | 38 | 100 |
| DC: yes | 67 | 67 | 33 | 41 | 67 | 25 | 50 | 63 | 0 |
The individual time profile of the sum of the largest diameters of target lesions (LD) is presented graphically for each patient in the Clinical Trial Report (CTR) only. No descriptive statistics were planned.
No measurements were reported for this outcome.
The PK of volasertib will be presented for the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) for the population attending the D1 schedule, the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 168 hours (AUC0-168) for the population attending the D1+ D8 schedule and the maximum measured concentration of volasertib in plasma (Cmax). In this outcome measure AUC0-∞ is presented.
| in nanogram*hours/millilitre (ng*h/mL) | V100 D1 | V200 D1 | V250 D1 | V300 D1 | V350 D1 |
|---|---|---|---|---|---|
| Pharmacokinetics (PK) AUC0-∞ of Volasertib | 2140 ± 15.9 | 3280 ± 28.6 | 6140 ± 38.9 | 6260 ± 40.3 | 9790 ± 14.6 |
The PK of volasertib will be presented for the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) for the population attending the D1 schedule, the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 168 hours (AUC0-168) for the population attending the D1+ D8 schedule and the maximum measured concentration of volasertib in plasma (Cmax). In this outcome measure AUC0-168 is presented.
| in nanogram*hours/millilitre (ng*h/mL) | V50 D1, D8 | V100 D1, D8 | V150 D1, D8 | V200 D1, D8 |
|---|---|---|---|---|
| AUC0-168, 1st infusion | 590 ± 20.8 | 1380 ± 1.01 | 1890 ± 54.4 | 3320 ± 0.317 |
| AUC0-168, 2nd infusion | 847 ± 16.7 | 1870 ± 19.8 | 2620 ± 67.1 | 4300 ± 16.0 |
The PK of volasertib will be presented for the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) for the population attending the D1 schedule, the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 168 hours (AUC0-168) for the population attending the D1+ D8 schedule and the maximum measured concentration of volasertib in plasma (Cmax). In this outcome measure Cmax is presented.
| ng/mL | V100 D1 | V200 D1 | V250 D1 | V300 D1 | V350 D1 | V50 D1, D8 | V100 D1, D8 | V150 D1, D8 | V200 D1, D8 |
|---|---|---|---|---|---|---|---|---|---|
| After infusion Day 1 | 186 ± 7.87 | 540 ± 31.5 | 540 ± 37.0 | 489 ± 33.1 | 675 ± 3.19 | 106 ± 67.3 | 234 ± 2.99 | 235 ± 32.5 | 410 ± 22.1 |
| After infusion Day 8 | — | — | — | — | — | 104 ± 47.6 | 212 ± 31.9 | 240 ± 49.4 | 431 ± 1.15 |
Collected over From inclusion into the study to 21 days after last drug administration (up to 548 days). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| V100 D1 | — | 1/3 (33.3%) | 3/3 (100%) |
| V200 D1 | — | 0/3 (0%) | 3/3 (100%) |
| V250 D1 | — | 2/6 (33.3%) | 6/6 (100%) |
| V300 D1 | — | 7/17 (41.2%) | 17/17 (100%) |
| V350 D1 | — | 1/3 (33.3%) | 3/3 (100%) |
| V50 D1, D8 | — | 0/4 (0%) | 3/4 (75%) |
| V100 D1, D8 | — | 2/4 (50%) | 4/4 (100%) |
| V150 D1, D8 | — | 7/16 (43.8%) | 16/16 (100%) |
| V200 D1, D8 | — | 2/3 (66.7%) | 3/3 (100%) |
| Event | V100 D1 | V200 D1 | V250 D1 | V300 D1 | V350 D1 | V50 D1, D8 | V100 D1, D8 | V150 D1, D8 | V200 D1, D8 |
|---|---|---|---|---|---|---|---|---|---|
| IleusGastrointestinal disorders | 0/3 | 0/3 | 1/6 | 0/17 | 0/3 | 0/4 | 0/4 | 0/16 | 2/3 |
| Febrile neutropeniaBlood and lymphatic system disorders | 0/3 | 0/3 | 0/6 | 2/17 | 1/3 | 0/4 | 0/4 | 0/16 | 0/3 |
| NeutropeniaBlood and lymphatic system disorders | 0/3 | 0/3 | 0/6 | 0/17 | 1/3 | 0/4 | 0/4 | 0/16 | 0/3 |
| Upper gastrointestinal haemorrhageGastrointestinal disorders | 1/3 | 0/3 | 0/6 | 0/17 | 0/3 | 0/4 | 0/4 | 0/16 | 0/3 |
| FatigueGeneral disorders | 0/3 | 0/3 | 0/6 | 0/17 | 0/3 | 0/4 | 0/4 | 0/16 | 1/3 |
| InfectionInfections and infestations | 0/3 | 0/3 | 0/6 | 1/17 | 0/3 | 0/4 | 0/4 | 0/16 | 1/3 |
| C-reactive protein increasedInvestigations | 0/3 | 0/3 | 0/6 | 0/17 | 0/3 | 0/4 | 0/4 | 0/16 | 1/3 |
| Decreased appetiteMetabolism and nutrition disorders | 0/3 | 0/3 | 0/6 | 0/17 | 0/3 | 0/4 | 0/4 | 0/16 | 1/3 |
| Oesophageal stenosisGastrointestinal disorders | 0/3 | 0/3 | 0/6 | 1/17 | 0/3 | 0/4 | 1/4 | 0/16 | 0/3 |
| HaemoptysisRespiratory, thoracic and mediastinal disorders | 0/3 | 0/3 | 0/6 | 0/17 | 0/3 | 0/4 | 1/4 | 0/16 | 0/3 |
| Event | V100 D1 | V200 D1 | V250 D1 | V300 D1 | V350 D1 | V50 D1, D8 | V100 D1, D8 | V150 D1, D8 | V200 D1, D8 |
|---|---|---|---|---|---|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 1/3 | 0/3 | 5/6 | 7/17 | 3/3 | 1/4 | 1/4 | 6/16 | 3/3 |
| NeutropeniaBlood and lymphatic system disorders | 1/3 | 1/3 | 2/6 | 12/17 | 3/3 | 1/4 | 1/4 | 6/16 | 2/3 |
| ThrombocytopeniaBlood and lymphatic system disorders | 1/3 | 1/3 | 3/6 | 12/17 | 3/3 | 0/4 | 1/4 | 1/16 | 2/3 |
| LeukopeniaBlood and lymphatic system disorders | 1/3 | 0/3 | 3/6 | 13/17 | 2/3 | 0/4 | 2/4 | 6/16 | 2/3 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/3 | 0/3 | 1/6 | 1/17 | 0/3 | 1/4 | 3/4 | 3/16 | 0/3 |
| Abdominal painGastrointestinal disorders | 1/3 | 0/3 | 0/6 | 3/17 | 0/3 | 0/4 | 0/4 | 4/16 | 2/3 |
| Abdominal pain upperGastrointestinal disorders | 0/3 | 2/3 | 2/6 | 1/17 | 0/3 | 1/4 | 0/4 | 0/16 | 0/3 |
| NauseaGastrointestinal disorders | 0/3 | 1/3 | 1/6 | 4/17 | 2/3 | 0/4 | 1/4 | 4/16 | 0/3 |
| Upper gastrointestinal haemorrhageGastrointestinal disorders | 0/3 | 0/3 | 0/6 | 0/17 | 0/3 | 0/4 | 0/4 | 1/16 | 2/3 |
| AstheniaGeneral disorders | 0/3 | 0/3 | 1/6 | 1/17 | 1/3 | 0/4 | 0/4 | 0/16 | 2/3 |
The treated set consisted of all patients who received at least one dose of volasertib.
| Age, Continuous(years) | V100 D1 | V200 D1 | V250 D1 | V300 D1 | V350 D1 | V50 D1, D8 | V100 D1, D8 | V150 D1, D8 | V200 D1, D8 | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 69.7 ± 8.0 | 55.7 ± 9.3 | 52.0 ± 4.7 | 53.4 ± 11.4 | 52.3 ± 9.1 | 48.5 ± 8.5 | 51.5 ± 18.2 | 60.2 ± 10.0 | 66.7 ± 3.1 | 56.2 ± 11.1 |
| Sex: Female, Male(Participants) | V100 D1 | V200 D1 | V250 D1 | V300 D1 | V350 D1 | V50 D1, D8 | V100 D1, D8 | V150 D1, D8 | V200 D1, D8 | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Female | 1 | 1 | 3 | 5 | 2 | 2 | 2 | 7 | 1 | 24 |
| Male | 2 | 2 | 3 | 12 | 1 | 2 | 2 | 9 | 2 | 35 |
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: BI 6727