Japanese BAY80-6946 Monotherapy Phase I Study

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: July 27, 2011
Last updated: July 10, 2013
Last verified: July 2013

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.

Condition Intervention Phase
Drug: BAY80-6946
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Single Centre, Phase I Study of PI3K Inhibitor BAY80-6946 to Evaluate the Safety, Tolerability and Pharmacokinetics in Japanese Patients With Advanced or Refractory Solid Tumours

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Number of subjects with adverse events by the administration of BAY80-6946 [ Time Frame: In Cycle 1 which consists of 28 days. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Area under the plasma concentration-time curve of (AUC) of BAY80-6946 [ Time Frame: In Cycle 1 which consists of 28 days ] [ Designated as safety issue: No ]
  • Plasma RACmax(Accumulation ratio calculated from maximum drug concentration) of BAY80-6946 [ Time Frame: In Cycle 3 which consists of 28 days ] [ Designated as safety issue: No ]
  • Plasma RAAUC( Accumulation ratio calculated from area under the plasma concentration-time curve) of BAY80-6946 [ Time Frame: In Cycle 3 which consists of 28 days ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: August 2011
Study Completion Date: July 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: BAY80-6946
0.4mg/ kg, iv, day 1,8 and 15, every 28 days
Experimental: Arm 2 Drug: BAY80-6946
0.8mg/ kg, iv, day 1,8 and 15, every 28 days


Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01404390

Kashiwa, Chiba, Japan, 277-8577
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Head Medical Development Japan, Bayer Yakuhin, Ltd.
ClinicalTrials.gov Identifier: NCT01404390     History of Changes
Other Study ID Numbers: 15205
Study First Received: July 27, 2011
Last Updated: July 10, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:
Phase I

Additional relevant MeSH terms:

ClinicalTrials.gov processed this record on April 22, 2014