Japanese BAY1000394 Monotherapy Phase I Study

ID: NCT02047890
Status: Active, not recruiting
Phase: Phase 1
Start Date: May 19, 2014
First Submitted: January 27, 2014
Last Updated: February 13, 2018
Results: N/A
Organization: Bayer
Sponsors & Collaborators: Bayer
Location: Japan
Conditions: Neoplasms
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Study Description

Brief Summary

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.

Detailed Description

Condition or disease Intervention/treatment Phase

Neoplasms

Drug: BAY1000394 (2.5mg)
Other Names
Drug: BAY1000394 (5mg)
Other Names
Phase 1

Tracking Information

First Submitted DateJanuary 27, 2014
Last Update Posted DateFebruary 13, 2018
Actual Start DateMay 19, 2014
Anticipated Completion DateApril 26, 2019
Actual Primary Completion DateJanuary 06, 2015
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Number of participants with adverse events as a measure of safety and tolerability [Time Frame: 6 months]

  • Number of participants with abnormal lab parameters based on descriptive statistics [Time Frame: 6 months]

  • Plasma concentration of BAY1000394 [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)]

  • Plasma concentration of the metabolite M1 (BAY107-7746) [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)]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Tumor response [Time Frame: Screening and on Day 21 of even numbered cycle]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleJapanese BAY1000394 Monotherapy Phase I Study
Official TitleAn 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
Brief Summary

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.

Detailed Description

Study TypeInterventional
Study PhasePhase 1
Estimated Enrollment
12
Allocation
Not Available
Interventional Model
Single Group Assignment
Masking
None (Open Label)
Primary Purpose
Treatment
Conditions
Neoplasms
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: BAY1000394 (2.5mg)

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

Other Names
Drug: BAY1000394 (5mg)

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

Other Names
Study Groups/Cohorts
BAY1000394
Approximately 12 subjects will be included: 3 to 6 evaluable subjects for each cohort. The cycle length will be 3 weeks (21 days).

Study Arms
Experimental BAY1000394
Approximately 12 subjects will be included: 3 to 6 evaluable subjects for each cohort. The cycle length will be 3 weeks (21 days).
Drug : BAY1000394 (2.5mg)
BAY1000934 2.5mg twice a day (bid) in a 3 days on and 4 days off schedule. (Cohort 1)

Experimental BAY1000394
Approximately 12 subjects will be included: 3 to 6 evaluable subjects for each cohort. The cycle length will be 3 weeks (21 days).
Drug : BAY1000394 (5mg)
BAY1000934 5mg twice a day (bid) in a 3 days on and 4 days off schedule. (Cohort 2)

Arm Intervention/Treatment
Experimental BAY1000394
Approximately 12 subjects will be included: 3 to 6 evaluable subjects for each cohort. The cycle length will be 3 weeks (21 days).
Drug : BAY1000394 (2.5mg)
Experimental BAY1000394
Approximately 12 subjects will be included: 3 to 6 evaluable subjects for each cohort. The cycle length will be 3 weeks (21 days).
Drug : BAY1000394 (5mg)

Recruitment Information

Recruitment Status:Active, not recruiting
Enrollment12
Completion DateApril 26, 2019
Eligibility Criteria: 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
GenderAll
Age20 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Japan

Administrative Information

NCT Number:NCT02047890
Other Study ID Numbers
15200
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Bayer
Collaborators
Not Available
Investigators
Study Director
Bayer Study Director
Bayer