Overview

This trial is active, not recruiting.

Condition neoplasms
Treatments bi 836845, low dose, every week (qw), bi 836845, middle dose, qw, bi 836845, high dose, qw
Phase phase 1
Sponsor Boehringer Ingelheim
Start date June 2014
End date June 2015
Trial size 21 participants
Trial identifier NCT02145741, 1280.15

Summary

This open-label dose escalation phase I trial, 1280.15, is with the first administration of BI 836845 in Japanese patients with various types of advanced solid tumours. The rationale behind this study is to identify the maximum tolerated dose (MTD) of BI 836845 in Japanese patients with advanced solid tumours as weekly intravenous administration.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients to receive low, middle, and high doses of BI 836845 intravenously (IV)
bi 836845, low dose, every week (qw)
Patient to receive low dose of BI 836845 IV
bi 836845, middle dose, qw
Patient to receive middle dose of BI 836845 IV
bi 836845, high dose, qw
Patient to receive high dose of BI 836845 IV

Primary Outcomes

Measure
Maximum tolerated dose (MTD) of BI 836845 in Japanese patients with advanced solid tumours (as identified by the number of patients with dose-limiting toxicities(DLTs))
time frame: 21 days

Eligibility Criteria

Male or female participants at least 20 years old.

Inclusion criteria: Patients who meet all of the following inclusion criteria by the judgment of investigator are eligible to receive the study treatment: 1. Patients with cytologically or histologically confirmed solid tumours that are refractory to standard therapy, for whom no standard therapy of proven efficacy exists, or who are not amenable to establish treatment options 2. Age >=20 years old 3. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 4. Written informed consent that is consistent with Good Clinical Practice (GCP) guidelines Exclusion criteria: Patients who apply any of the following exclusion criteria by the judgment of investigator are not eligible to receive the study treatment: 1. Active infectious disease to be incompatible with the study treatment 2. Patients who do not have sufficient major organ function and meet any of the following test results at screening period - Cardiac left ventricular function with resting ejection fraction <=50% as determined by echocardiography (ECHO) or multiple-gated acquisition scan (MUGA) - Absolute neutrophil count <1500/µL - Platelets <100 000/µL - Total bilirubin >1.5 × the upper limit of normal (ULN) - Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2.5 × ULN (in case of known liver metastases, AST and/or ALT >5 × ULN) - Creatinine >1.5 × ULN - Haemoglobin <9 g/dL - HbA1c >=8% and fasting glucose >8.9 mmol/L (>160 mg/dL) 3. Serious illness or concomitant non-oncological disease including severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that may compromise the safety of the patient during the study, affect the patient's ability to complete the study, or interfere with interpretation of study results considered by the investigator to be incompatible with the study treatment 4. History of thrombosis (except tumour invading great vessels) within 1 year before start of study treatment or if concurrent anticoagulation required 5. Patients not recovered from any therapy-related toxicities from previous chemotherapies, hormonal therapies, immunotherapies, molecular-targeted therapies, or radiotherapies to Common Terminology Criteria for Adverse Events (CTCAE) grade <=1 6. Patients who have not recovered from any previous surgery and major surgery within the last 4 weeks before start of study treatment 7. Patients with untreated or symptomatic brain metastases. 8. Patients who have been treated with any of the following within 4 weeks before start of study treatment: chemotherapies, immunotherapies, radiotherapies (within 2 weeks before start of study treatment for local palliative radiotherapies for the treatment of brain metastasis or extremities), biological therapies, molecular-targeted therapies, hormonal therapies for breast cancer within 2 weeks before start of study treatment, or treatment with other investigational drugs. 9. Patients who have used any investigational drug within 4 weeks before start of study treatment or who have planned concomitantly use with the trial. 10. Patients unable to comply with the clinical trial protocol (CTP)

Additional Information

Official title An Open-label Phase I Dose Escalation Trial of Weekly Intravenous Administrations of BI 836845 in Japanese Patients With Advanced Solid Tumours
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.