Overview

This trial is active, not recruiting.

Condition neoplasms
Treatments bay1000394 (2.5mg), bay1000394 (5mg)
Phase phase 1
Sponsor Bayer
Start date May 2014
End date January 2015
Trial size 12 participants
Trial identifier NCT02047890, 15200

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Approximately 12 subjects will be included: 3 to 6 evaluable subjects for each cohort. The cycle length will be 3 weeks (21 days).
bay1000394 (2.5mg)
BAY1000934 2.5mg twice a day (bid) in a 3 days on and 4 days off schedule. (Cohort 1)
bay1000394 (5mg)
BAY1000934 5mg twice a day (bid) in a 3 days on and 4 days off schedule. (Cohort 2)

Primary Outcomes

Measure
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)

Secondary Outcomes

Measure
Tumor response
time frame: Screening and on Day 21 of even numbered cycle

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Bayer.