BI 811283 in Various Solid Tumours
An Open Phase I Single Dose Escalation Study of Two Dosing Schedules of BI 811283 Administered Intravenously Over 24 h Continuous Infusion in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit
2 other identifiers
interventional
124
1 country
2
Brief Summary
The main objective of this trial is to provide safety data in terms of drug-related adverse events (AE) for the recommendation of the dose for further trials in the development of BI 811283. Secondary objectives are the collection of antitumour efficacy data and the determination of the pharmacokinetic profile of BI 811283.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2007
Longer than P75 for phase_1
2 active sites
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
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 18, 2008
CompletedFirst Posted
Study publicly available on registry
June 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedJuly 22, 2014
July 1, 2014
3.9 years
June 18, 2008
July 21, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Maximum tolerated dose
3-4 weeks
Secondary Outcomes (2)
Safety profile: incidence and intensity of AEs graded according to the common terminology criteria for AEs, incidence of DLT
throughout the study period
Progression free survival (PFS), Objective response, Response duration, Pharmacodynamic analysis, Basic pharmacokinetics
throughout the study period
Study Arms (2)
Arm A
EXPERIMENTALBI 811283, 24h infusion d1 and d15 every 4 weeks
Arm B
EXPERIMENTALBI 811283, 24h infusion d1 every 3 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Patients with confirmed diagnosis of advanced, non-resectable and/or metastatic solid 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 Evaluable tumour deposits Recovery from reversible toxicities of prior anti-cancer therapies Age \>= 18 years Life expectancy \>= 6 months Written informed consent in accordance with International Conference on Harmonisation (ICH) guideline for Good Clinical Practice (GCP) and local legislation Eastern Cooperative Oncology Group performance score \<= 2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
1247.1.49002 Boehringer Ingelheim Investigational Site
Essen, Germany
1247.1.49001 Boehringer Ingelheim Investigational Site
Freiburg/Breisgau, Germany
Related Publications (1)
Mross K, Richly H, Frost A, Scharr D, Nokay B, Graeser R, Lee C, Hilbert J, Goeldner RG, Fietz O, Scheulen ME. A phase I study of BI 811283, an Aurora B kinase inhibitor, in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2016 Aug;78(2):405-17. doi: 10.1007/s00280-016-3095-6. Epub 2016 Jun 27.
PMID: 27349901DERIVED
MeSH Terms
Conditions
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2008
First Posted
June 19, 2008
Study Start
June 1, 2007
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
July 22, 2014
Record last verified: 2014-07