NeoplasmsPhase 1NCT01145885

BI 6727 (Volasertib) Human ADME Trial in Various Solid Tumours

A Phase 1 study testing BI 6727 in people with Neoplasms, run by Boehringer Ingelheim at 1 site in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Investigation of absorption, distribution, metabolism and excretion (ADME) and assessment of safety, tolerability and preliminary therapeutic effects of [14C]volasertib in patients with advanced solid tumours. Read more about this study

Who is it for?: Ages 18 to 70 years, men only
Conditions the study is for: Neoplasms
What is being tested?: BI 6727
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteHungary
Study dates: Jun 2010to Nov 2010
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Inclusion Criteria 1. Patients with histologically or cytologically confirmed diagnosis of advanced, non resectable and / or metastatic solid tumour
Inclusion Criteria 5. Eastern Cooperative Oncology Group (ECOG) performance score =<2
Inclusion Criteria 6. Recovery from Common Terminology Criteria for Adverse Events (CTCAE) Grade >=2 therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapy

Who cannot join

Exclusion Criteria 1. Serious concomitant non-oncological disease considered by the investigator
Exclusion Criteria 3. Viral hepatitis, Human Immunodeficiency Virus (HIV) infection
Exclusion Criteria 4. Clinical evidence of active brain metastasis during the past 6 months
Exclusion Criteria 5. Second malignancy currently requiring active therapy
Exclusion Criteria 6. Absolute neutrophil count less than 1,500/mm3
Exclusion Criteria 7. Platelet count less than 100,000/mm3

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Exclusion Criteria 8. Total bilirubin greater than 1.5 mg/dL
Exclusion Criteria 9. Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)
Exclusion Criteria 10. Serum creatinine greater than 1.5x Upper Limit of Normal (ULN).
Exclusion Criteria 11. Known history of QT/QTcF-prolongation
Exclusion Criteria 12. Patients who are sexually active and having a partner with childbearing potential and unwilling to use a medically acceptable method of contraception
Exclusion Criteria 13. Treatment with other investigational drugs or participation in another clinical trial
Exclusion Criteria 14. Chemo-, radio- immuno-, or molecular-targeted cancer-therapy within the past four weeks prior to start of therapy or concomitantly with this trial. This restriction does not apply to steroids and bisphosphonates.
Exclusion Criteria 17. Potent Cytochrome P450 enzyme (CYP) 3A4 and P-glycoprotein inhibitors or inducers
Exclusion Criteria 18. History of allergy/hypersensitivity

Trial locations and contacts

1 site in 1 country.

Hungary1 site

1230.23.36001 Boehringer Ingelheim Investigational Site
Budapest

Other trials in Hungary

About this study

Official title: Investigation of the Metabolism, Excretion and Pharmacokinetics of an Openlabel Single Dose of 300 mg [14C]Volasertib Administered Intravenously in Patients With Various Solid Tumours With a Possible Extension Phase With Nonlabelled Drug

Conditions: Neoplasms
Being tested: BI 6727
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BI 6727Drug
PLK-1 inhibitor

Study groups in NCT01145885
Study group	Role	What they receive
BI 6727	Experimental	BI 6727 cycles in every 21 days Receives: Drug: BI 6727

What is being measured

The primary outcome is the main question the study is designed to answer.

Individual Time Course Profiles of 14C-radioactivity in Whole Blood and Plasma: Cmax of 14C Labelled Volasertib
Individual time course profiles of 14C-radioactivity in whole blood and plasma: Cmax of 14C labelled Volasertib.
Measured: 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.
Individual Time Course Profiles of 14C-radioactivity in Urine: Cumulative Fraction of 14C-ratioactivity Excreted in Urine
Percentage of administered dose excreted in urine as 14C-radioactivity over time
Measured: Every 24 hours, up to 504 hours
Individual Time Course Profiles of 14C-radioactivity in Faeces: Cumulative Fraction of 14C-radioactivity Excreted in Faeces
Percentage of administered dose excreted in faeces as 14C-radioactivity over time
Measured: Every 24 hours, up to 504 hours
Individual Time Course Profiles of Volasertib and CD 10899 in Plasma: Cmax of Volasertib and CD 10899 (a Metabolite of Volasertib).
Individual time course profiles of volasertib (BI 6727) and a metabolite of volasertib (CD 10899), in plasma: Cmax of Volasertib and CD 10899.
Measured: Plasma: Pre-dose (-0.5h) and 1.0h, 1.983h, 4h, 6h, 8h, 24h,48h. 96h, 168h and 336h after start of drug infusion.
Individual Time Course Profile of Volasertib in Urine:Cumulative Fraction of Volasertib Excreted in Urine
Percentage of administered dose excreted in urine as volasertib (BI 6727) over time
Measured: Every 24 hours, up to 504 hours
Individual Time Course Profile of CD 10899 in Urine: Cumulative Amount of CD 10899 Excreted in Urine
Cumulative amounts of CD 10899, a metabolite of volasertib, excreted in urine over time
Measured: Every 24 hours, up to 504 hours
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.
Cumulative Percentage of 14C-radioactivity excreted in urine and faeces at 504 hours after start of drug infusion related to total [14C] volasertib administered.
Measured: up to 504 hours
Cmax of Volasertib and CD 10899 in Plasma
Maximum measured concentration of volasertib and CD 10899, a metabolite of volasertib, in plasma (Cmax).
Measured: 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
AUC0-inf of Volasertib and CD10899 in Plasma
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).
Measured: 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
CL/R of Volasertib and CD 10899 in Urine
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.
Measured: Every 24 hours, up to 504 hours
Ae(0-tz) of Volasertib and CD 10899 in Urine
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.
Measured: Every 24 hours, up to 504 hours
AUC0-tz of 14C Radioactivity in Plasma and Whole Blood
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).
Measured: 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 blood
Ae(0-tz) of 14C Radioactivity in Urine
Amount of analyte eliminated in urine within the time interval 0 to to the last quantifiable data point (Ae(0-tz)) of 14C radioactivity
Measured: Every 24 hours, up to 504 hours
Ae,Faeces(0-tz) of 14C Radioactivity
Amount of analyte excreted in faeces within the time interval 0 to to the last quantifiable data point (Ae(0-tz)) of 14C radioactivity
Measured: Every 24 hours, up to 504 hours
Time Dependency of Cblood Cells/Cplasma Ratio and Cblood/Cplasma Ratio of 14C-radioactivity
Time dependency of Cblood cells/Cplasma ratio and Cblood/Cplasma ratio of 14C-radioactivity.
Measured: 1.983 hours and 6 hours
Elucidation of Metabolite Structures and Identification of Major Metabolites in Plasma, Urine, and Faeces
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.
Measured: 3 weeks

Secondary outcomes (3)

Percentage of Participants With Drug Related Adverse Events
Percentage of participants with drug related adverse events (AEs)
Measured: From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
Percentage of Participants With Clinically Relevant Abnormalities for Clinical Assessments, ECG, Vital Signs and Laboratory Tests
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.
Measured: From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
Percentage of Participants With Clinical Benefit
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).
Measured: 21, 42 and 63 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2010Nov 2010

First posted17 Jun 2010 (estimated)
Study startJun 2010
Primary completionNov 2010
Study completionNov 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for NeoplasmsStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01145885
Sponsor's protocol ID: 1230.23
Other IDs: 2009-018199-32, 2009
Status last verified: Aug 2018
First submitted: 16 Jun 2010
Last updated: 31 Jan 2019
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
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All Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of the Metabolism, Excretion and Pharmacokinetics of an Openlabel Single Dose of 300 mg [14C]Volasertib Administered Intravenously in Patients With Various Solid Tumours With a Possible Extension Phase With Nonlabelled Drug
ClinicalTrials.gov ID: NCT01145885
Acronym / sponsor ID: 1230.23
Conditions: Neoplasms
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 7 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jun 2010
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 17 Jun 2010 (estimated)
Results: Posted 31 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BI 6727	Experimental	Drug: BI 6727BI 6727 cycles in every 21 days

Who may qualify

Ages: 18 to 70 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Inclusion Criteria 1. Patients with histologically or cytologically confirmed diagnosis of advanced, non resectable and / or metastatic solid tumour
Inclusion Criteria 5. Eastern Cooperative Oncology Group (ECOG) performance score =<2
Inclusion Criteria 6. Recovery from Common Terminology Criteria for Adverse Events (CTCAE) Grade >=2 therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapy

Key exclusion criteria (15 listed)

Exclusion Criteria 1. Serious concomitant non-oncological disease considered by the investigator
Exclusion Criteria 3. Viral hepatitis, Human Immunodeficiency Virus (HIV) infection
Exclusion Criteria 4. Clinical evidence of active brain metastasis during the past 6 months
Exclusion Criteria 5. Second malignancy currently requiring active therapy
Exclusion Criteria 6. Absolute neutrophil count less than 1,500/mm3

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BI 6727PLK-1 inhibitor	Drug	BI 6727

Primary outcome

Individual Time Course Profiles of 14C-radioactivity in Whole Blood and Plasma: Cmax of 14C Labelled Volasertib
Time frame: 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.
Individual time course profiles of 14C-radioactivity in whole blood and plasma: Cmax of 14C labelled Volasertib.
Individual Time Course Profiles of 14C-radioactivity in Urine: Cumulative Fraction of 14C-ratioactivity Excreted in Urine
Time frame: Every 24 hours, up to 504 hours
Percentage of administered dose excreted in urine as 14C-radioactivity over time
Individual Time Course Profiles of 14C-radioactivity in Faeces: Cumulative Fraction of 14C-radioactivity Excreted in Faeces
Time frame: Every 24 hours, up to 504 hours
Percentage of administered dose excreted in faeces as 14C-radioactivity over time
Individual Time Course Profiles of Volasertib and CD 10899 in Plasma: Cmax of Volasertib and CD 10899 (a Metabolite of Volasertib).
Time frame: Plasma: Pre-dose (-0.5h) and 1.0h, 1.983h, 4h, 6h, 8h, 24h,48h. 96h, 168h and 336h after start of drug infusion.
Individual time course profiles of volasertib (BI 6727) and a metabolite of volasertib (CD 10899), in plasma: Cmax of Volasertib and CD 10899.
Individual Time Course Profile of Volasertib in Urine:Cumulative Fraction of Volasertib Excreted in Urine
Time frame: Every 24 hours, up to 504 hours
Percentage of administered dose excreted in urine as volasertib (BI 6727) over time
Individual Time Course Profile of CD 10899 in Urine: Cumulative Amount of CD 10899 Excreted in Urine
Time frame: Every 24 hours, up to 504 hours
Cumulative amounts of CD 10899, a metabolite of volasertib, excreted in urine over time
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.
Time frame: up to 504 hours
Cumulative Percentage of 14C-radioactivity excreted in urine and faeces at 504 hours after start of drug infusion related to total [14C] volasertib administered.
Cmax of Volasertib and CD 10899 in Plasma
Time frame: 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
Maximum measured concentration of volasertib and CD 10899, a metabolite of volasertib, in plasma (Cmax).
AUC0-inf of Volasertib and CD10899 in Plasma
Time frame: 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
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).
CL/R of Volasertib and CD 10899 in Urine
Time frame: Every 24 hours, up to 504 hours
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.
Ae(0-tz) of Volasertib and CD 10899 in Urine
Time frame: Every 24 hours, up to 504 hours
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.
AUC0-tz of 14C Radioactivity in Plasma and Whole Blood
Time frame: 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 blood
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).
Ae(0-tz) of 14C Radioactivity in Urine
Time frame: Every 24 hours, up to 504 hours
Amount of analyte eliminated in urine within the time interval 0 to to the last quantifiable data point (Ae(0-tz)) of 14C radioactivity
Ae,Faeces(0-tz) of 14C Radioactivity
Time frame: Every 24 hours, up to 504 hours
Amount of analyte excreted in faeces within the time interval 0 to to the last quantifiable data point (Ae(0-tz)) of 14C radioactivity
Time Dependency of Cblood Cells/Cplasma Ratio and Cblood/Cplasma Ratio of 14C-radioactivity
Time frame: 1.983 hours and 6 hours
Time dependency of Cblood cells/Cplasma ratio and Cblood/Cplasma ratio of 14C-radioactivity.
Elucidation of Metabolite Structures and Identification of Major Metabolites in Plasma, Urine, and Faeces
Time frame: 3 weeks
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.

3 secondary outcomes

Percentage of Participants With Drug Related Adverse Events
Time frame: From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
Percentage of Participants With Clinically Relevant Abnormalities for Clinical Assessments, ECG, Vital Signs and Laboratory Tests
Time frame: From first intake of study drug until 21 days after last intake of the study drug, up to 63 days
Percentage of Participants With Clinical Benefit
Time frame: 21, 42 and 63 days

Results and safety

Results posted to the registry on 31 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Volasertib	7	0

Primary outcome: Individual Time Course Profiles of 14C-radioactivity in Whole Blood and Plasma: Cmax of 14C Labelled Volasertib

Time frame: 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.. Geometric mean (Geometric Coefficient of Variation). Unit: nmol/L

Measure	Volasertib 14C 300 mg n = 6
Whole Blood	1746 (18.0)
Plasma	1150 (14.7)

Population analysed: 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.

Primary outcome: Individual Time Course Profiles of 14C-radioactivity in Urine: Cumulative Fraction of 14C-ratioactivity Excreted in Urine

Time frame: Every 24 hours, up to 504 hours. Geometric mean (Geometric Coefficient of Variation). Unit: Percentage of dose

Measure	Volasertib 14C 300 mg n = 6
0-24 hours	4.21 (33.8)
0-168 hours	11.7 (23.9)
0-336 hours	15.6 (22.5)
0-504 hours	18.1 (21.9)

Population analysed: PK set

Primary outcome: Individual Time Course Profiles of 14C-radioactivity in Faeces: Cumulative Fraction of 14C-radioactivity Excreted in Faeces

Time frame: Every 24 hours, up to 504 hours. Geometric mean (Geometric Coefficient of Variation). Unit: Percentage of dose

Measure	Volasertib 14C 300 mg n = 6
0-24 hours	0.680 (433)
0-168 hours	24.4 (46.2)
0-336 hours	36.7 (33.0)
0-504 hours	42.5 (29.3)

Population analysed: PK set

Primary outcome: Individual Time Course Profiles of Volasertib and CD 10899 in Plasma: Cmax of Volasertib and CD 10899 (a Metabolite of Volasertib).

Time frame: Plasma: Pre-dose (-0.5h) and 1.0h, 1.983h, 4h, 6h, 8h, 24h,48h. 96h, 168h and 336h after start of drug infusion.. Geometric mean (Geometric Coefficient of Variation). Unit: nmol/L

Measure	Volasertib 14C 300 mg n = 6
Volasertib (1.983 hours)	926 (17.8)
CD 10899 (6 hours)	9.92 (29.8)

Population analysed: PK set

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first intake of study drug until 21 days after last intake of the study drug, up to 63 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Volasertib 14C 300mg	0 of 7 (0%)	7 of 7 (100%)	Not reported
Volasertib 300mg	1 of 3 (33.3%)	3 of 3 (100%)	Not reported
Total_Volasertib 300	1 of 7 (14.3%)	7 of 7 (100%)	Not reported
Volasertib 250mg	0 of 2 (0%)	2 of 2 (100%)	Not reported
Volasertib	1 of 7 (14.3%)	7 of 7 (100%)	Not reported

Limitations and caveats (from the sponsor): Due to improper mixing of the infusion solution, the actual dose administered could not reliably be determined for one patient so the PK data for this patient were excluded from the analyses.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 6727 in people with Neoplasms, run by Boehringer Ingelheim at 1 site in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Individual Time Course Profiles of 14C-radioactivity in Whole Blood and Plasma: Cmax of 14C Labelled Volasertib (time frame: 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.). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01145885.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019; AzTrials last refreshed its copy on 6 Nov 2026.