Status:
COMPLETED
Japanese BAY80-6946 Monotherapy Phase I Study
Lead Sponsor:
Bayer
Conditions:
Neoplasms
Eligibility:
All Genders
20-80 years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 18 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01404390
Start Date
August 18 2011
End Date
July 12 2012
Last Update
December 14 2017
Active Locations (1)
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1
Kashiwa, Chiba, Japan, 277-8577