Japanese BAY1000394 Monotherapy Phase I Study

Bayer

Status and phase

Completed

Phase 1

Conditions

Neoplasms

Treatments

Drug: BAY1000394 (5mg)

Drug: BAY1000394 (2.5mg)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02047890

15200

Details and patient eligibility

About

This is an open-label, non-randomized, dose-escalating Phase I study to evaluate the safety, tolerability, pharmacokinetics of BAY1000394 given in a 3 days on / 4 days off schedule in Japanese subjects with advanced malignancies.

Enrollment

12 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Japanese male or female subjects aged ≥20 years
Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 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, or subjects must have actively refused any treatment which would be regarded standard, and if in the judgment of the investigator, experimental treatment is clinically and ethically acceptable
At least 1 tumor lesion evaluable by computer tomography (CT) or scan or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Adequate bone marrow, liver, and renal functions

Exclusion criteria

Anticancer chemotherapy or immunotherapy within 4 weeks of study entry. Mitomycin C or nitrosoureas should not be given within 6 weeks of study entry.
Radiotherapy to target lesions within 3 weeks prior to the first dose of study drug.
Use of biological response modifiers, such as granulocyte colony-stimulating factor (G-CSF), within 3 weeks prior to the first dose of study drug.
Symptomatic metastatic brain or meningeal tumors.
Investigational drug treatment outside of this study during or within 4 weeks prior to study entry.
Blood pressure <100/60 mmHg or pulse >100 BPM