Text Size

Japanese BAY80-6946 Monotherapy Phase I Study

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01404390
First received: July 27, 2011
Last updated: July 23, 2012
Last verified: July 2012
History of Changes
  Purpose

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
Neoplasms
 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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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

  Eligibility

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

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

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

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

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 23, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:
Phase I
Japanese

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 19, 2013