Japanese BAY1000394 Monotherapy Phase I Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-19

Study Completion Date

2018-07-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BAY1000394

Approximately 12 subjects will be included: 3 to 6 evaluable subjects for each cohort. The cycle length will be 3 weeks (21 days).

Group Type EXPERIMENTAL

BAY1000394 (2.5mg)

Intervention Type DRUG

BAY1000934 2.5mg twice a day (bid) in a 3 days on and 4 days off schedule. (Cohort 1)

BAY1000394 (5mg)

Intervention Type DRUG

BAY1000934 5mg twice a day (bid) in a 3 days on and 4 days off schedule. (Cohort 2)

Interventions

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BAY1000394 (2.5mg)

BAY1000934 2.5mg twice a day (bid) in a 3 days on and 4 days off schedule. (Cohort 1)

Intervention Type DRUG

BAY1000394 (5mg)

BAY1000934 5mg twice a day (bid) in a 3 days on and 4 days off schedule. (Cohort 2)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No