- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02145741
Weekly Intravenous Administrations of BI 836845 in Japanese Patients With Advanced Solid Tumours
An Open-label Phase I Dose Escalation Trial of Weekly Intravenous Administrations of BI 836845 in Japanese Patients With Advanced Solid Tumours
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Chiba, Kashiwa, Japan, 277-8577
- National Cancer Center Hospital East
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria:
Patients who meet all of the following inclusion criteria by the judgment of investigator are eligible to receive the study treatment:
- 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
- Age >=20 years old
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- 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:
- Active infectious disease to be incompatible with the study treatment
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)
- 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
- History of thrombosis (except tumour invading great vessels) within 1 year before start of study treatment or if concurrent anticoagulation required
- 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
- Patients who have not recovered from any previous surgery and major surgery within the last 4 weeks before start of study treatment
- Patients with untreated or symptomatic brain metastases.
- 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.
- Patients who have used any investigational drug within 4 weeks before start of study treatment or who have planned concomitantly use with the trial.
- Patients unable to comply with the clinical trial protocol (CTP)
Study Plan
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: Xentuzumab
Patients to receive low, middle, and high doses of Xentuzumab intravenously (IV)
|
Patient to receive low dose of Xentuzumab IV
Patient to receive middle dose of Xentuzumab IV
Patient to receive high dose of Xentuzumab IV
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
21 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Boehringer Ingelheim, Boehringer Ingelheim
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1280.15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:
- studies in products where Boehringer Ingelheim is not the license holder;
- studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
- studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).
For more details refer to: https://www.mystudywindow.com/msw/datasharing
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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