Study Completed

Neoplasms

Bayer Identifier:

15200

ClinicalTrials.gov Identifier:

NCT02047890

EudraCT Number:

Not Available

EU CT Number:

Not Available

Japanese BAY1000394 monotherapy Phase I study

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.

Key Participants Requirements

Sex

Both

Age

20 - N/A

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

Trial Dates

May 2014 - July 2018

Phase

Phase 1

Could I Receive a placebo

Products

Roniciclib (BAY1000394)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Kashiwa, 277-8577, Japan
Completed		Fukuoka, 811-1395, Japan

Primary Outcome

Number of participants with adverse events as a measure of safety and tolerability
Time Frame:
6 months
Safety Issue:
Yes
Number of participants with abnormal lab parameters based on descriptive statistics
Time Frame:
6 months
Safety Issue:
Yes
Maximum observed drug concentration (Cmax) for BAY1000394 and its metabolite M-1
Time Frame:
Cycle 1 / Day 1: 0 (pre dose), 0.5, 1, 2, 4, 6, 8, 12 and 24 hours (Day 2, before morning dose). Cycle 1 / Day 10 : 0 (before morning dose), 0.5, 1, 2, 4, 6, 8 and 12 hours (before evening dose)
Safety Issue:
No
Cmax divided by dose per body weight (Cmax,norm) for BAY1000394 and its metabolite M-1
Time Frame:
Cycle 1 / Day 1: 0 (pre dose), 0.5, 1, 2, 4, 6, 8, 12 and 24 hours (Day 2, before morning dose). Cycle 1 / Day 10 : 0 (before morning dose), 0.5, 1, 2, 4, 6, 8 and 12 hours (before evening dose)
Safety Issue:
No
Cmax divided by dose (Cmax/D) for BAY1000394 and its metabolite M-1
Time Frame:
Cycle 1 / Day 1: 0 (pre dose), 0.5, 1, 2, 4, 6, 8, 12 and 24 hours (Day 2, before morning dose). Cycle 1 / Day 10 : 0 (before morning dose), 0.5, 1, 2, 4, 6, 8 and 12 hours (before evening dose)
Area under the concentration versus time curve from zero to infinity after single dose (AUC) for BAY1000394 and its metabolite M-1
Time Frame:
= Cycle 1 / Day 1: 0 (pre dose), 0.5, 1, 2, 4, 6, 8, 12 and 24 hours (Day 2, before morning dose)
AUC from time 0 to 12 hours after single dose (AUC(0-12) for BAY1000394 and its metabolite M-1
Time Frame:
Cycle 1 / Day 1: 0 (pre dose), 0.5, 1, 2, 4, 6, 8 and 12 hours
AUC divided by dose per body weight (AUCnorm) for BAY1000394 and its metabolite M-1
Time Frame:
Cycle 1 / Day 1: 0 (pre dose), 0.5, 1, 2, 4, 6, 8, 12 and 24 hours (Day 2, before morning dose)
AUCnorm from time 0 to 12 hours after single dose (AUC(0-12),norm) for BAY1000394 and its metabolite M-1
Time Frame:
Cycle 1 / Day 1: 0 (pre dose), 0.5, 1, 2, 4, 6, 8 and 12 hours
AUC divided by dose (AUC/D) for BAY1000394 and its metabolite M-1
Time Frame:
Cycle 1 / Day 1: 0 (pre dose), 0.5, 1, 2, 4, 6, 8, 12 and 24 hours (Day 2, before morning dose)
Time to reach Cmax (tmax) for BAY1000394 and its metabolite M-1
Time Frame:
Cycle 1 / Day 1: 0 (pre dose), 0.5, 1, 2, 4, 6, 8, 12 and 24 hours (Day 2, before morning dose). Cycle 1 / Day 10 : 0 (before morning dose), 0.5, 1, 2, 4, 6, 8 and 12 hours (before evening dose)
Terminal half-life (t½) for BAY1000394 and its metabolite M-1
Time Frame:
Cycle 1 / Day 1: 0 (pre dose), 0.5, 1, 2, 4, 6, 8, 12 and 24 hours (Day 2, before morning dose). Cycle 1 / Day 10 : 0 (before morning dose), 0.5, 1, 2, 4, 6, 8 and 12 hours (before evening dose)
Maximum observed drug concentration after multiple dosing (Cmax,md) for BAY1000394 and its metabolite M-1
Time Frame:
Cycle 1 / Day 10 : 0 (before morning dose), 0.5, 1, 2, 4, 6, 8 and 12 hours (before evening dose)
Cmax divided by dose per body weight after multiple dosing (Cmax,norm,md) for BAY1000394 and its metabolite M-1
Time Frame:
Cycle 1 / Day 10 : 0 (before morning dose), 0.5, 1, 2, 4, 6, 8 and 12 hours (before evening dose)
Cmax divided by dose (Cmax,md/D) for BAY1000394 and its metabolite M-1
Time Frame:
Cycle 1 / Day 10 : 0 (before morning dose), 0.5, 1, 2, 4, 6, 8 and 12 hours (before evening dose)
AUC from time 0 to 12 hours after multiple dosing (AUC(0-12),md) for BAY1000394 and its metabolite M-1
Time Frame:
Cycle 1 / Day 10 : 0 (before morning dose), 0.5, 1, 2, 4, 6, 8 and 12 hours (before evening dose)
AUCnorm from time 0 to 12 hours after multiple dosing (AUC(0-12),norm,md) for BAY1000394 and its metabolite M-1
Time Frame:
Cycle 1 / Day 10 : 0 (before morning dose), 0.5, 1, 2, 4, 6, 8 and 12 hours (before evening dose)
AUC from time 0 to 12 hours divided by dose after multiple dosing for BAY1000394 and its metabolite M-1
Time Frame:
Cycle 1 / Day 10 : 0 (before morning dose), 0.5, 1, 2, 4, 6, 8 and 12 hours (before evening dose)

Secondary Outcome

Tumor response
Time Frame:
Screening and on Day 21 of even numbered cycle
Safety Issue:
No

Trial design

An open-label, 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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

N/A

Blinding

Open Label

Assignment

Single Group Assignment

Trial Arms

Additional Information

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