Trial Condition(s):

Neoplasms

Japanese BAY1000394 monotherapy Phase I study

Bayer Identifier:

15200

ClinicalTrials.gov Identifier:

NCT02047890

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
12
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Roniciclib (BAY1000394)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Kashiwa, Japan, 277-8577

Status
Completed
 
Locations

Investigative Site

Fukuoka, Japan, 811-1395

Status
Completed
 

Trial Design