Overview

This trial has been completed.

Condition neoplasms
Treatment bay1143572
Phase phase 1
Sponsor Bayer
Start date September 2013
End date August 2016
Trial size 80 participants
Trial identifier NCT01938638, 16519

Summary

The purpose of this study Part A is to determine the safety, tolerability and the pharmacokinetics of BAY1143572 in subjects with advanced malignancies, which are either refractory to or ineligible for treatment with standard agents.

The purpose of this study Part B is:

Determine the safety, tolerability, pharmacokinetics (PK) and maximum tolerated dose (MTDG-CSF) of BAY1143572 with concurrent administration of the granulocyte colony-stimulating factors (G-CSF) in an intermittent and continuous dosing schedule in subjects with advanced malignancies.

United States Massachusetts, Michigan, New York, and South Carolina
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
BAY1143572 will be administered from cycle 1, day 1 (C1D1) onwards once daily continuously
bay1143572
(Experimental)
BAY1143572 will be administered from C1D1 in a 3 days on/4 days off schedule
bay1143572

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 (MTD) of BAY1143572
time frame: Up to 1 years

Secondary Outcomes

Measure
Maximum total bound drug concentration (Cmax) in plasma after single dose administration
time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on day 1 and day 15

Eligibility Criteria

Male or female participants at least 21 years old.

Inclusion Criteria: - Male or female subjects aged >/=21 years - Dose escalation and expansion phase: Subjects with histologically or cytologically confirmed advanced malignancies (gastric cancer, triple negative breast cancer [TNBC] or diffuse large B-cell lymphoma [DLBCL]), who are refractory to or have exhausted all available therapies. Subjects should have evaluable or measurable disease (as per RECIST 1.1,or Cheson 2007 criteria). - Archival tumor tissue to conduct molecular and / or genetic studies must be collected from all study subjects enrolled in this study. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 - Life expectancy of at least 12 weeks - Adequate bone marrow, liver, and renal functions as assessed by laboratory analysis to be conducted within 7 days prior to the first dose of study drug - International normalized ratio (INR) and partial thromboplastin time (PTT) New York Heart Association (NYHA) Class II, unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6 months) or myocardial infarction within the past 6 months and cardiac arrhythmias requiring anti-arrhythmic therapy except for beta-blockers and digoxin; evidence for uncontrolled coronary artery disease (e.g. angina pectoris, myocardial infarction within 6 months prior to study entry, major regional wall motion abnormalities upon baseline echocardiography) - Previous pulmonary embolism within 12 months prior to study entry - Uncontrolled hypertension defined as systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg on 2 or more consecutive blood pressure readings, despite optimal medical management - Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C - Known history of human immunodeficiency virus (HIV) infection - Chronic or active hepatitis B or C, requiring antiviral therapy - Active clinically serious infections of > Grade 2 and/or active infections that require treatment with systemic agent - Uncontrolled seizure disorder requiring therapy (such as steroids or anti-epileptics with significant CYP interaction) - Evidence or history of bleeding disorder, i.e. any hemorrhage / bleeding event of > Grade 2 within 4 weeks prior to the first dose of study drug

Additional Information

Official title An Open-label Phase I Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of BAY1143572 Given in a Once-daily or an Intermittent Dosing Schedule in Subjects With Advanced Malignancies
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Bayer.