Japanese BAY80-6946 Monotherapy Phase I Study

Bayer

Status and phase

Completed

Phase 1

Conditions

Neoplasms

Treatments

Drug: BAY80-6946

Study type

Interventional

Funder types

Industry

Identifiers

NCT01404390

15205

Details and patient eligibility

About

This study will be conducted as an open label, single centre, Phase I study of PI3K (phosphatidyl inositol 3 kinase) inhibitor BAY80-6946 in Japanese patients with advanced or refractory solid tumours. The eligible subjects will be dosed intravenously at Day 1, Day 8 and Day 15 with three weeks on and one week off in each treatment cycle.

Enrollment

10 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Cancer patients
Japanese patients, who are at least 20 years of age
Histological or cytological documentation of non-hematologic, malignant solid tumours, excluding primary brain or spinal tumours, with no past or current involvement in the central nervous system (CNS)
At least one measurable lesion or evaluable disease according to RECIST (version 1.1)
Eastern Cooperative Oncology performance status (ECOG-PS) of 0 or 1
Life expectancy of at least 12 weeks
Advanced or refractory solid tumours not amenable to standard therapy, at the first screening examination/visit

Exclusion criteria

Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of first study treatment. Patients must have recovered from the toxic effects of the previous anti-cancer chemotherapy or immunotherapy by the investigator (with the exception of alopecia).
Radiotherapy to target lesions during study or within 4 weeks of first study treatment
Investigational drug therapy outside of this trial during or within 4 weeks of first study treatment
Current diagnosis of Type I or II diabetes mellitus or fasting blood glucose level >125 mg/dL at screening, and/or HbA1c>/= 6.5%
Past and current histories of cardiac disease congestive heart failure > New York Heart Association (NYHA) Class II; active coronary artery disease, myocardial infarction within 6 months prior to study entry; new onset of angina within 3 months prior to study entry or unstable angina or ventricular cardiac arrhythmias requiring anti-arrhythmic therapy
Active and clinically serious infections >Grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 4.03)
Uncontrolled hypertension defined as systolic blood pressure >150 mm Hg or diastolic pressure > 90 mm Hg, despite optimal medical management
Patients undergoing renal dialysis
Pregnant or breast feeding women