Phase I Study of BI 831266 in Patients With Advanced Solid Tumours

NCT ID: NCT00756223

Last Updated: 2013-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30

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.

Conditions

Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

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

Group Type: EXPERIMENTAL

Arm A

Intervention Type: DRUG

Dose escalation Arm A (4 weeks)

Arm B

BI 831266 24h infusion on day 1 every 3 weeks

Group Type: EXPERIMENTAL

Arm B

Intervention Type: DRUG

Dose escalation Arm B (3 weeks)

Interventions

Arm A

Dose escalation Arm A (4 weeks)

Intervention Type: DRUG

Arm B

Dose escalation Arm B (3 weeks)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Boehringer Ingelheim

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1257.1.4303 Boehringer Ingelheim Investigational Site

Linz, , Austria

1257.1.4302 Boehringer Ingelheim Investigational Site

Salzburg, , Austria

1257.1.4301 Boehringer Ingelheim Investigational Site

Vienna, , Austria

Countries

Austria

References

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.

Reference Type: DERIVED

PMID: 25529193 (View on PubMed)

Other Identifiers

2008-001631-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1257.1

Identifier Type: -

Identifier Source: org_study_id