Clinical trial NCT00756223: Phase I Study of BI 831266 in Patients With Advanced Solid Tumours
Official title: An Open-label Phase I Single Dose Escalation Trial of Two Dosing Schedules of BI 831266 Administered Intravenously Over 24 h Continuously in Patients With Advanced Solid Tumours
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-09-22
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion criteria:

1. 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
2. Secure central venous access
3. Measurable and/or non-measurable tumour deposits
4. Recovery from toxicities of prior anti-cancer therapies at least to CTCAE grade 1
5. Age \>= 18 years
6. Life expectancy \>= 3 months
7. Written informed consent in accordance with International Conference on Harmonisation guideline for Good Clinical Practice and local legislation
8. Eastern Cooperative Oncology Group performance score \<= 2

Exclusion criteria:

1. 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
2. Pregnancy or breastfeeding
3. Symptomatic brain metastases and/or leptomeningeal disease requiring therapy
4. Second malignancy requiring therapy
5. Left ventricular ejection fraction (LVEF) \< 50% in echocardiography
6. 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
7. Absolute neutrophil count less than 1500 / mm3
8. Platelet count less than 100 000 / mm3
9. Bilirubin greater than 1.5 mg / dl (\> 26 micromol / L, SI unit equivalent)
10. 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)
11. Serum creatinine greater than 1.5 mg / dl (\> 132 micromol / L, SI unit equivalent)
12. Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
13. Treatment with other investigational drugs or in another clinical trial within the past two weeks before start of therapy or concomitantly with this trial
14. Chemo-, hormone, radio- or immunotherapy within the past two weeks before start of therapy or concomitantly with this trial
15. Patients unable to comply with the protocol
16. Active alcohol or drug abuse

Primary outcomes:
measure: Maximum tolerated dose
timeFrame: 3-4 weeks
Secondary outcomes:
measure: Safety parameters (incidence and intensity of AEs graded according to the common terminology criteria for AEs and incidence of DLT)
timeFrame: throughout the study period
measure: Pharmacokinetic parameters
timeFrame: throughout the study period
measure: Pharmacodynamic analysis
timeFrame: 3-4 weeks
measure: Efficacy data (progression free survival, objective response rate, response duration)
timeFrame: throughout the study period
Other outcomes:
Locations:
city: Linz
country: Austria
facility: 1257.1.4303 Boehringer Ingelheim Investigational Site
city: Salzburg
country: Austria
facility: 1257.1.4302 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 1257.1.4301 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.