BI 811283 in Various Solid Tumours

NCT ID: NCT00701324

Last Updated: 2014-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2011-05-31

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.

Conditions

Neoplasms

Study Design

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

Study Groups

Arm A

BI 811283, 24h infusion d1 and d15 every 4 weeks

Group Type: EXPERIMENTAL

BI 811283

Intervention Type: DRUG

dose escalation BI 811283, Arm A (day 1)

BI 811283

Intervention Type: DRUG

dose escalation BI 811283, Arm A (day 15)

Arm B

BI 811283, 24h infusion d1 every 3 weeks

Group Type: EXPERIMENTAL

BI 811283

Intervention Type: DRUG

dose escalation BI 811283, Arm B (3 weeks)

Interventions

BI 811283

dose escalation BI 811283, Arm B (3 weeks)

Intervention Type: DRUG

BI 811283

dose escalation BI 811283, Arm A (day 1)

Intervention Type: DRUG

BI 811283

dose escalation BI 811283, Arm A (day 15)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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 Known brain metastases Second malignancy requiring therapy Left ventricular ejection fraction (LVEF) < 50% in echocardiography or clinical congestive heart failure New York Heart Association grade III - IV Myocardial infarction within the last 6 months prior to inclusion or symptomatic coronary artery disease Absolute neutrophil count less than 1500 / mm3 Platelet count less than 100 000 / mm3 Bilirubin greater than 1.5 mg / dl (> 26 mcmol / 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 mcmol / 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 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

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1247.1.49002 Boehringer Ingelheim Investigational Site

Essen, , Germany

1247.1.49001 Boehringer Ingelheim Investigational Site

Freiburg/Breisgau, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 27349901 (View on PubMed)

Other Identifiers

2007-000191-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1247.1

Identifier Type: -

Identifier Source: org_study_id