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Japanese BAY80-6946 Monotherapy Phase I Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01404390
First Posted: July 28, 2011
Last Update Posted: December 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  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
Intervention Model: Factorial Assignment
Masking: None (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

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Number of subjects with adverse events [ Time Frame: 169 days ]
  • Maximum drug concentration in plasma after single dose administration (Cmax) [ Time Frame: 0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15, 0 - 8 hours in Cycle3 Day15 ]
  • Cmax divided by dose (mg) per kg body weight (Cmax,norm) [ Time Frame: 0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15, 0 - 8 hours in Cycle3 Day15 ]
  • Cmax divided by dose (mg) (Cmax/D) [ Time Frame: 0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15, 0 - 8 hours in Cycle3 Day15 ]
  • Area under the concentration-time curve time 0 to 8 hours (AUC(0-8)) [ Time Frame: 0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15, 0 - 8 hours in Cycle3 Day15 ]
  • Area under the concentration-time curve from time 0 to 25 hours (AUC(0-25)) [ Time Frame: 0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15 ]
  • AUC(0-25) divided by dose (mg) per kg body weight (AUC(0-25)norm) [ Time Frame: 0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15 ]
  • AUC(0-25) divided by dose (mg) (AUC(0-25)/D) [ Time Frame: 0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15 ]
  • AUC from time 0 to last data point (AUC(0-tlast)) [ Time Frame: 0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15 ]
  • Time to maximum drug concentration in plasma (tmax) [ Time Frame: 0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15, 0 - 8 hours in Cycle3 Day 15 ]

Secondary Outcome Measures:
  • Area under the plasma concentration-time curve of (AUC) of BAY80-6946 [ Time Frame: 0 - 168 hours in Cycle1 Day1 ]
  • Half-life associated with terminal slope of drug in plasma (t1/2) [ Time Frame: 0 - 168 hours in Cycle1 Day1 ]
  • Mean residence time of drug in plasma (MRT) [ Time Frame: 0 - 168 hours in Cycle1 Day1 ]
  • Total body clearance of drug from plasma (CL) [ Time Frame: 0 - 168 hours in Cycle1 Day1 ]
  • Volume of drug distribution during terminal phase after single dose administration (Vz) [ Time Frame: 0 - 168 hours in Cycle1 Day1 ]
  • Volume of drug distribution during steady state after single dose administration (Vss) [ Time Frame: 0 - 168 hours in Cycle1 Day1 ]
  • Accumulation ratio calculated from AUC(0-8) after multiple dosing and AUC(0-8) after single dosing (RAAUC(0-8)) [ Time Frame: 0 - 8 hours in Cycle3 Day15 ]
  • Accumulation ratio calculated from AUC(0-25) after multiple dosing and AUC(0-25) after single dosing (RAAUC(0-25)) [ Time Frame: 0 - 25 hours in Cycle1 Day15 ]
  • Accumulation ration calculated from Cmax after multiple dosing and Cmax after single dosing (RACmax) [ Time Frame: 0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15 ]
  • Overall tumor response rate [ Time Frame: 176 days ]
    Proportion of subjects with confirmed complete and partial response

  • Overall disease control rate [ Time Frame: 176 days ]
    Proportion of subjects who had a best response rating of complete response, partial response or stable disease

  • Time to progression of cancer growth [ Time Frame: 176 days ]
  • Progression-free survival time [ Time Frame: 176 days ]

Enrollment: 10
Actual Study Start Date: August 18, 2011
Study Completion Date: July 12, 2012
Primary Completion Date: March 22, 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01404390


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