Trial Condition(s):

Neoplasms

Phase I dose escalation study of BAY94-9343 given by intravenous infusion every 3 weeks in Japanese subjects with advanced malignancies

Bayer Identifier:

15404

ClinicalTrials.gov Identifier:

NCT02485119

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The primary objectives of the Phase I study 15404 are to evaluate the safety, tolerability and pharmacokinetics of BAY94-9343 given once every 3 weeks in Japanese subjects with advanced, refractory solid tumors.
The secondary objectives are to investigate the efficacy, biomarkers and immunogenicity.

Inclusion Criteria
- Japanese subjects ≥ 20 years of age 
 - ECOG Performance Status of 0 to 1
 - Life expectancy of at least 12 weeks
 - Subjects with advanced, histologically or cytologically confirmed solid tumors, not amenable to any standard therapy, have no standard therapy available
 - Subjects whose fresh or archival tumor tissues are available
 - Measurable disease with at least one lesion that can be accurately measured in at least one dimension according to RECIST criteria (Version 1.1 or modified version)
 - Adequate bone marrow, liver, and renal function
Exclusion Criteria
- Anticancer chemotherapy, experimental cancer therapy, or immunotherapy within 2 weeks of start of the first dose
 - Impaired cardiac function or clinically significant cardiac disease (i.e., congestive heart failure (CHF) NYHA Class III or IV)
 - Myocardial infarction or onset of unstable angina < 3 months prior to general screening
 - Cardiac arrhythmias in the electrocardiogram that would interfere with QT/QTc interval measurement (LBBB (left bundle branch block), AV block, atrial fibrillation)
 - QTc >470 ms, derived as the average of the 3 values measured by the ECG recorder’s algorithm on the ECG triplicate
 - LVEF (left ventricular ejection fraction) <50 %
 - Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 90 mmHg, despite optimal medical management
 - Known human immunodeficiency virus (HIV) infection
 - Subjects with an active hepatitis B or C infection requiring treatment
 - Personal or family history of Long QT Syndrome (LQTS)
 - Subject with clinically significant eye disorders

Trial Summary

Enrollment Goal
12
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Anetumab ravtansine (BAY94-9343)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

National Cancer Center Hospital East

Kashiwa, Japan, 277-8577

Status
Completed
 
Locations

National Cancer Center Hospital

Tyuo, Japan, 104-0045

Status
Completed
 

Trial Design