Open Label Phase I Dose Escalation Study With BAY1143572 in Patients With Advanced Cancer

Bayer

Status and phase

Completed

Phase 1

Conditions

Neoplasms

Treatments

Drug: BAY1143572

Study type

Interventional

Funder types

Industry

Identifiers

NCT01938638

16519

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female subjects aged >/=21 years
Dose escalation phase: Subjects with histologically or cytologically confirmed advanced malignancies (solid tumors and malignant lymphomas) who were refractory to or had exhausted all available therapies. Subjects had to have evaluable or measurable disease (as per RECIST 1.1 or Cheson 2007 criteria).
Expansion phase only: Subjects with advanced, histologically or cytologically confirmed gastric cancer, triple negative breast cancer (TNBC), or diffuse large B-cell lymphoma (DLBCL), who were refractory to or had exhausted all available therapies. Subjects had to 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) </=1.5 times ULN (upper limit of normal)

Exclusion criteria

Known hypersensitivity to the study drug or excipients of the preparation or any agent given in association with this study
History of cardiac disease including congestive heart failure > 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