Open Label Study of BAY1082439 in Patients With Advanced Cancer

NCT ID: NCT01728311

Last Updated: 2018-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-21
• Study Completion Date: 2017-02-06

Brief Summary

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

Conditions

Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

BAY1082439

Intervention Type: DRUG

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

Interventions

BAY1082439

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

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Singapore, , Singapore

Singapore, , Singapore

Seoul, , South Korea

Seoul, , South Korea

Taipei, , Taiwan

Countries

Singapore; South Korea; Taiwan

Other Identifiers

15734

Identifier Type: -

Identifier Source: org_study_id