Overview

This trial is active, not recruiting.

Condition neoplasms
Treatment bay1082439
Phase phase 1
Sponsor Bayer
Start date November 2012
End date June 2016
Trial size 60 participants
Trial identifier NCT01728311, 15734

Summary

The purpose of this study is to determine the safety, tolerability and the pharmacokinetics of BAY1082439

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)
bay1082439
BAY1082439 will be given orally once daily with a 21 days cycle. Dose will be started from 15mg.

Primary Outcomes

Measure
Number of participants with adverse events as a measure of safety and tolerability
time frame: Up to 2 years
Maximum tolerated dose of BAY1082439
time frame: Up to 1 year
Maximum observed plasma concentration (Cmax) of BAY1082439 after a single dose
time frame: Serial PK samples will be selected during cycle 1 day 1 (pre-dose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose) and sparse samples during the rest of the cycle as well as in cycle 2
Time to Cmax (tmax) of BAY1082439 after a single dose
time frame: Serial PK samples will be selected during cycle 1 day 1 (pre-dose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose) and sparse samples during the rest of the cycle as well as in cycle 2
Area under the plasma concentration-time curve (AUC[0-t]) of BAY1082439 after a single dose
time frame: Serial PK samples will be selected during cycle 1 day 1 (pre-dose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose) and sparse samples during the rest of the cycle as well as in cycle 2

Secondary Outcomes

Measure
Area under the concentration-time curve over the dosing interval (AUC[0-tau])
time frame: PK parameters following single and repeat-dose administration in cycle 1
Maximum observed concentration (Cmax)
time frame: PK parameters following single and repeat-dose administration in cycle 1
Time of occurrence of Cmax (tmax)
time frame: PK parameters following single and repeat-dose administration in cycle 1
Terminal phase half-life (t1/2)
time frame: PK parameters following single and repeat-dose administration in cycle 1

Eligibility Criteria

Male or female participants at least 21 years old.

Inclusion Criteria: - Subjects with advanced, histologically or cytologically confirmed solid tumors, refractory to any standard therapy, have no standard therapy available, or subjects must have actively refused any treatment which would be regarded standard, and / or if in the judgment of the investigator, experimental treatment is clinically and ethically acceptable - Expansion phase only: Subjects with histologically or cytologically confirmed, locally advanced or metastatic endometrial cancer or breast cancer or iNHL, who are refractory to or have exhausted all available therapies - International normalized ratio (INR) and partial thromboplastin time (PTT) <1.5 x ULN [Subjects on anticoagulation with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.] For subjects on warfarin, close monitoring of at least weekly evaluations will be performed until INR is stable based on a measurement at pre-dose, as defined by the local standard of care - Measurable or evaluable disease - Life expectancy of at least 12 weeks - Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 - Adequate bone marrow, liver and renal function Exclusion Criteria: - History of cardiac disease: congestive heart failure > New York Heart Association (NYHA) Class II, unstable angina (anginal symptoms at rest), new-onset angina (within the past 3 months prior to the first dose of study drug), myocardial infarction within the past 6 months prior to the first dose of study drug, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) - Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management - History of diabetes mellitus or gestational diabetes mellitus - Fasting blood glucose level >125 mg/dL or HbA1c 7% at screening - Active clinically serious infections > Grade 2 - History of organ allograft - Seizure disorder requiring therapy (such as steroids or anti-epileptics)

Additional Information

Official title An Open-label Phase I Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of BAY 1082439 Given Once Daily Continuously or in an Intermittent Dosing Schedule in 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.