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Phase I Dose Escalation Study of BAY94-9343 Given by Intravenous Infusion Every 3 Weeks in Japanese Subjects With Advanced Malignancies

Brief Summary

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.

Tracking Information
First Received DateJune 26, 2015
Last Changed DateJune 7, 2017
Start DateAugust 14, 2015
Actual Primary Completion DateApril 28, 2017
Primary Outcome Measures

Number of Treatment-emergent Adverse Events (TEAEs) as a measure of safety and tolerability [Time Frame: Up to 9 weeks]

Intensity of TEAEs acc. to NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) v.4.03 [Time Frame: Up to 9 weeks]

Cmax (maximum drug concentration in plasma after single dose administration ) for BAY94-9343, total antibody compound, DM4, metabolite DM4-Me [Time 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)]

Cmax,norm (Cmax divided by dose (mg) per kg body weight) for BAY94-9343, total antibody compound, DM4, metabolite DM4-Me [Time 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)]

Cmax/D (Cmax divided by dose (mg)) for BAY94-9343, total antibody compound, DM4, metabolite DM4-Me [Time 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)]

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 [Time 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)]

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 [Time 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)]

AUC(0-tlast)/D (AUC(0-tlast) divided by dose (mg)) for BAY94-9343, total antibody compound, DM4, metabolite DM4-Me [Time 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)]

tmax (time to reach maximum drug concentration in plasma) for BAY94-9343, total antibody compound, DM4, metabolite DM4-Me [Time 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)]

Secondary Outcome Measures

Tumor response based on RECIST (Response Evaluation Criteria in Solid Tumors) [Time Frame: Up to 9 weeks]

Level of mesothelin expression using IHC (Immunohistochemistry) staining for the tumor tissue obtained from fresh or archival tumor tissue [Time Frame: Up to 9 weeks]

Plasma levels of soluble mesothelin [Time Frame: Up to 9 weeks]

Immunogenicity evaluation based on anti-BAY94-9343 antibody count [Time Frame: Up to 9 weeks]

Descriptive Information
PhasePhase 1
Study TypeInterventional
Condition
  • Neoplasms
Intervention
  • Drug: BAY94-9343
Study Arms / Comparison Groups1 / 0
Recruitment Information
Recruitment StatusActive, not recruiting
Anticipated Enrollment15
GenderAll
Ages20 Years - N/A
Accepts Healthy VolunteersNo
Eligibility Criteria

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

Administrative Information
NCTIDNCT02485119
Responsible Party,
SponsorBayer
Verification DateJune 2017
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