Trial Condition(s):

Neoplasms

Open label Phase I dose escalation study with BAY1143572 in patients with advanced cancer

Bayer Identifier:

16519

ClinicalTrials.gov Identifier:

NCT01938638

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
80
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Atuveciclib (BAY1143572)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Seoul, South Korea, 110-744

Status
Completed
Locations

Investigative Site

Singapore, Singapore, 119228

Status
Completed
Locations

Investigative Site

Singapore, Singapore, 169610

Status
Completed
Locations

Investigative Site

Seoul, South Korea, 120-752

Status
Completed
Locations

Investigative Site

New York, United States, 10032

Status
Completed
Locations

Investigative Site

Boston, United States, 02215

Status
Terminated
Locations

Investigative Site

Taipei, Taiwan, China, 10002

Status
Terminated
Locations

Investigative Site

Seoul, South Korea, 05505

Status
Completed
Locations

Investigative Site

Hackensack, United States, 07601

Status
Completed
Locations

Investigative Site

Charleston, United States, 29425

Status
Terminated
Locations

Investigative Site

Ann Arbor, United States, 48109

Status
Completed
Locations

Investigative Site

Fayetteville, United States, 72703

Status
Completed

Trial Design