NCT00756223

Brief Summary

The main objective of this trial is to provide safety data in terms of drug-related adverse events for the recommendation of the dose for further trials in the development of BI 831266. Secondary objectives are the collection of antitumour efficacy data and the determination of the pharmacokinetic and pharmacodynamic profile of BI 831266.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Last Updated

November 21, 2013

Status Verified

November 1, 2013

Enrollment Period

1.9 years

First QC Date

September 19, 2008

Last Update Submit

November 20, 2013

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose

    3-4 weeks

Secondary Outcomes (4)

  • Safety parameters (incidence and intensity of AEs graded according to the common terminology criteria for AEs and incidence of DLT)

    throughout the study period

  • Pharmacokinetic parameters

    throughout the study period

  • Pharmacodynamic analysis

    3-4 weeks

  • Efficacy data (progression free survival, objective response rate, response duration)

    throughout the study period

Study Arms (2)

Arm A

EXPERIMENTAL

BI 831266 24h infusion on day 1 and day 15 every 4 weeks

Drug: Arm A

Arm B

EXPERIMENTAL

BI 831266 24h infusion on day 1 every 3 weeks

Drug: Arm B

Interventions

Arm ADRUG

Dose escalation Arm A (4 weeks)

Arm A
Arm BDRUG

Dose escalation Arm B (3 weeks)

Arm B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with confirmed diagnosis of advanced, non-resectable and/or metastatic solid malignant tumours, who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not amenable to established treatment options
  • Secure central venous access
  • Measurable and/or non-measurable tumour deposits
  • Recovery from toxicities of prior anti-cancer therapies at least to CTCAE grade 1
  • Age \>= 18 years
  • Life expectancy \>= 3 months
  • Written informed consent in accordance with International Conference on Harmonisation guideline for Good Clinical Practice and local legislation
  • Eastern Cooperative Oncology Group performance score \<= 2

You may not qualify if:

  • Serious illness, concomitant non-oncological disease (e.g. active infectious disease), or ongoing toxicity of prior therapies considered by the investigator to potentially compromise patients' safety in this trial
  • Pregnancy or breastfeeding
  • Symptomatic brain metastases and/or leptomeningeal disease requiring therapy
  • Second malignancy requiring therapy
  • Left ventricular ejection fraction (LVEF) \< 50% in echocardiography
  • Clinically significant (i.e. active) cardiovascular disease: CVA/stroke (\<= 6 months prior to randomisation), myocardial infarction (\<= 6 months prior to randomisation), unstable angina, New York Heart Association Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
  • Absolute neutrophil count less than 1500 / mm3
  • Platelet count less than 100 000 / mm3
  • Bilirubin greater than 1.5 mg / dl (\> 26 micromol / L, SI unit equivalent)
  • 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)
  • Serum creatinine greater than 1.5 mg / dl (\> 132 micromol / L, SI unit equivalent)
  • Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
  • Treatment with other investigational drugs or in another clinical trial within the past two weeks before start of therapy or concomitantly with this trial
  • Chemo-, hormone, radio- or immunotherapy within the past two weeks before start of therapy or concomitantly with this trial
  • Patients unable to comply with the protocol
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

1257.1.4303 Boehringer Ingelheim Investigational Site

Linz, Austria

Location

1257.1.4302 Boehringer Ingelheim Investigational Site

Salzburg, Austria

Location

1257.1.4301 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

Related Publications (1)

  • Dittrich C, Fridrik MA, Koenigsberg R, Lee C, Goeldner RG, Hilbert J, Greil R. A phase 1 dose escalation study of BI 831266, an inhibitor of Aurora kinase B, in patients with advanced solid tumors. Invest New Drugs. 2015 Apr;33(2):409-22. doi: 10.1007/s10637-014-0201-7. Epub 2014 Dec 23.

    PMID: 25529193DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 19, 2008

First Posted

September 22, 2008

Study Start

November 1, 2008

Primary Completion

October 1, 2010

Last Updated

November 21, 2013

Record last verified: 2013-11

Locations

AU(3)