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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Neoplasms

Intervention / Treatment
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* Drug: Arm A
* Drug: Arm B


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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 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 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 Active alcohol or drug abuse

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>BI 831266 24h infusion on day 1 and day 15 every 4 weeks | Drug: Arm A<br>* Dose escalation Arm A (4 weeks)<br>|
| Experimental: Arm B<br>BI 831266 24h infusion on day 1 every 3 weeks | Drug: Arm B<br>* Dose escalation Arm B (3 weeks)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose |  | 3-4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |