check_circleStudy Completed

Neoplasms

Bayer Identifier:

15404

ClinicalTrials.gov Identifier:

NCT02485119

EudraCT Number:

Not Available

EU CT Number:

Not Available
Phase I dose escalation study of BAY94-9343 given by intravenous infusion every 3 weeks in Japanese subjects with advanced malignancies

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.

Key Participants Requirements

Sex

Both

Age

20 - N/A
  • - 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
  • - 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
August 2015 - July 2017
Phase
Phase 1
Could I Receive a placebo
No
Products
Anetumab ravtansine (BAY94-9343)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
National Cancer Center Hospital EastKashiwa, 277-8577, Japan
Completed
National Cancer Center HospitalTyuo, 104-0045, Japan

Primary Outcome

  • Number of Treatment-emergent Adverse Events (TEAEs) as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 9 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Intensity of TEAEs acc. to NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) v.4.03
    date_rangeTime Frame:
    Up to 9 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Cmax (maximum drug concentration in plasma after single dose administration ) for BAY94-9343, total antibody compound, DM4, metabolite DM4-Me
    date_rangeTime Frame:
    Cycle 1, 3 ,6: pre, 30, 60min, 1.5, 2, 3, 5, 8, 48, 96, 168 and 504 hours after the start of dosing; Cycle1,2 only: 336 hours; Cycle1 only: 24 hours (each cycle is 21 days)
    enhanced_encryption
    Safety Issue:
    No
  • Cmax,norm (Cmax divided by dose (mg) per kg body weight) for BAY94-9343, total antibody compound, DM4, metabolite DM4-Me
    date_rangeTime Frame:
    Cycle 1, 3 ,6: pre, 30, 60min, 1.5, 2, 3, 5, 8, 48, 96, 168 and 504 hours after the start of dosing; Cycle1,2 only: 336 hours; Cycle1 only: 24 hours (each cycle is 21 days)
    enhanced_encryption
    Safety Issue:
    No
  • Cmax/D (Cmax divided by dose (mg)) for BAY94-9343, total antibody compound, DM4, metabolite DM4-Me
    date_rangeTime Frame:
    Cycle 1, 3 ,6: pre, 30, 60min, 1.5, 2, 3, 5, 8, 48, 96, 168 and 504 hours after the start of dosing; Cycle1,2 only: 336 hours; Cycle1 only: 24 hours (each cycle is 21 days)
    enhanced_encryption
    Safety Issue:
    No
  • AUC(0-tlast) (area under the plasma concentration vs time curve from time 0 to the last data point) for BAY94-9343, total antibody compound, DM4, metabolite DM4-Me
    date_rangeTime Frame:
    Cycle 1, 3 ,6: pre, 30, 60min, 1.5, 2, 3, 5, 8, 48, 96, 168 and 504 hours after the start of dosing; Cycle1,2 only: 336 hours; Cycle1 only: 24 hours (each cycle is 21 days)
    enhanced_encryption
    Safety Issue:
    No
  • AUC(0-tlast)norm (AUC(0-tlast) divided by dose (mg) per kg body weight) for BAY94-9343, total antibody compound, DM4, metabolite DM4-Me
    date_rangeTime Frame:
    Cycle 1, 3 ,6: pre, 30, 60min, 1.5, 2, 3, 5, 8, 48, 96, 168 and 504 hours after the start of dosing; Cycle1,2 only: 336 hours; Cycle1 only: 24 hours (each cycle is 21 days)
    enhanced_encryption
    Safety Issue:
    No
  • AUC(0-tlast)/D (AUC(0-tlast) divided by dose (mg)) for BAY94-9343, total antibody compound, DM4, metabolite DM4-Me
    date_rangeTime Frame:
    Cycle 1, 3 ,6: pre, 30, 60min, 1.5, 2, 3, 5, 8, 48, 96, 168 and 504 hours after the start of dosing; Cycle1,2 only: 336 hours; Cycle1 only: 24 hours (each cycle is 21 days)
    enhanced_encryption
    Safety Issue:
    No
  • tmax (time to reach maximum drug concentration in plasma) for BAY94-9343, total antibody compound, DM4, metabolite DM4-Me
    date_rangeTime Frame:
    Cycle 1, 3 ,6: pre, 30, 60min, 1.5, 2, 3, 5, 8, 48, 96, 168 and 504 hours after the start of dosing; Cycle1,2 only: 336 hours; Cycle1 only: 24 hours (each cycle is 21 days)
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Tumor response based on RECIST (Response Evaluation Criteria in Solid Tumors)
    date_rangeTime Frame:
    Up to 9 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Level of mesothelin expression using IHC (Immunohistochemistry) staining for the tumor tissue obtained from fresh or archival tumor tissue
    date_rangeTime Frame:
    Up to 9 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Plasma levels of soluble mesothelin
    date_rangeTime Frame:
    Up to 9 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Immunogenicity evaluation based on anti-BAY94-9343 antibody count
    date_rangeTime Frame:
    Up to 9 weeks
    enhanced_encryption
    Safety Issue:
    No

Trial design

An open label, Phase I study to evaluate the safety, tolerability and pharmacokinetics of BAY94-9343 given by intravenous infusion every 3 weeks (Q3W) in Japanese subjects with advanced malignancies
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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