Japanese BAY1000394 Monotherapy Phase I Study

Study Description

Brief Summary

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 Date	January 27, 2014
Last Update Posted Date	February 13, 2018
Actual Start Date	May 19, 2014
Anticipated Completion Date	April 26, 2019
Actual Primary Completion Date	January 06, 2015
Results First Submitted Date	N/A
Received Results Disposit Date	N/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

Current Secondary Outcome Measures

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

Original Secondary Outcome Measures

Study Design

Brief Title	Japanese BAY1000394 Monotherapy Phase I Study
Official Title	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
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 Type	Interventional
Study Phase	Phase 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 Method	N/A
Study Population	N/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) 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)

Recruitment Information

Recruitment Status:	Active, not recruiting
Enrollment	12
Completion Date	April 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
Gender	All
Age	20 Years to N/A
Accepts Healthy Volunteers	No
Contacts	Not Available
Listed Location Countries	Japan

Administrative Information

NCT Number:	NCT02047890
Other Study ID Numbers	15200
Has Data Monitoring Committee	No
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