- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02674152
Dose Finding Study of BI 836880 in Patients With Solid Tumors
September 7, 2021 updated by: Boehringer Ingelheim
A First-in Human Phase I, Non-randomised, Open-label, Multi-center Dose Escalation Trial of BI 836880 Administered by Repeated Intravenous Infusions in Patients With Solid Tumors.
This is a Phase I, non-randomized, uncontrolled, open-label, dose escalating study of BI 836880 administered intravenously.
The eligible patient population will be patients with advanced solid tumours.
At any time during the trial, it will not be permitted to escalate to a dose which does not fulfil the escalation with overdose control (EWOC) criterion
Study Overview
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Age >= 18 years
- Histologically or cytologically confirmed malignancy which is locally advanced or metastatic solid tumor, and either refractory after standard therapy for the disease or for which standard therapy is not reliably effective, e.g. they do not tolerate or have contraindications to otherwise available standard therapy and tumour lesions evaluable for Dynamic contrast-enhanced (DCE)-MRI at MTD.
- ECOG performance status <= 2
- Adequate hepatic, renal and bone marrow functions
- Signed written informed consent.
- Life expectancy min. 3 months in the opinion of the investigator
- Recovery from all reversible adverse events of previous anti-cancer therapies to baseline or CTCAE grade 1, except for alopecia (any grade) sensory peripheral neuropathy CTCAE grade <= 2 or considered not clinically significant.
- adequate contraception by male and female patient during the trial and for at least 6 months after end of treatment.
Exclusion criteria:
- Known hypersensitivity to the trial drugs or their excipients
- Current or prior treatment with any systemic anti-cancer therapy either within 28 days or a minimum of 5 half-lives, whichever is shorter of trial onset.
- Serious concomitant disease, especially those affecting compliance with trial requirements or which are considered relevant for the evaluation of the endpoints of the trial drug
- Major injuries and/or surgery or bone fracture within 4 weeks of start of treatment, or planned surgical procedures during the trial period.
- patients with personal or family history of QT prolongation and/or long QT syndrome, or prolonged QTcF at baseline (> 470 ms). QTcF will be calculated by Investigator as the mean of the 3 ECGs taken at screening.
- Significant cardiovascular/cerebrovascular diseases (i.e. uncontrolled hypertension, unstable angina, history of infarction within past 6 months, congestive heart failure > NYHA II). Uncontrolled hypertension defined as: blood pressure in rested and relaxed condition >=140 mmHg systolic, or >=90 mmHg diastolic (with or without medication), measured according to protocol.
- History of severe haemorrhagic or thromboembolic event in the past 12 months (excluding central venous catheter thrombosis and peripheral deep vein thrombosis).
- Known inherited predisposition to bleeding or to thrombosis in the opinion of the investigator.
- Patient with brain metastases that are symptomatic and/or require therapy.
- Patients who require full-dose anticoagulation (according to local guidelines).
- Active alcohol or drug abuse in the opinion of the investigator.
- Patients who are under judicial protection and patients who are legally institutionalized.
- Patients unable or unwilling to comply with protocol
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BI 836880
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary endpoint to assess the maximum tolerated dose (MTD) is based on the number of patients presenting dose-limiting toxicities (DLTs) using CTCAE v4.03, judged to be related to the study medication evaluated over the first cycle of treatment.
Time Frame: 3 weeks
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients experiencing drug related AE leading to dose reduction or discontinuation from start of treatment until end of treatment
Time Frame: up to 24 weeks
|
up to 24 weeks
|
Exposure measures (AUC0-tz) after the first dose
Time Frame: 36 weeks
|
36 weeks
|
Disposition kinetic measures (t1/2 ) after the first dose
Time Frame: 36 weeks
|
36 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 5, 2016
Primary Completion (Actual)
September 12, 2018
Study Completion (Actual)
November 4, 2020
Study Registration Dates
First Submitted
January 4, 2016
First Submitted That Met QC Criteria
February 2, 2016
First Posted (Estimate)
February 4, 2016
Study Record Updates
Last Update Posted (Actual)
September 8, 2021
Last Update Submitted That Met QC Criteria
September 7, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 1336.1
- 2014-005395-28 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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