Japanese BAY80-6946 Monotherapy Phase I Study

December 13, 2017 updated by: Bayer

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1
Drug: BAY80-6946
0.4mg/ kg, iv, day 1,8 and 15, every 28 days
Drug: BAY80-6946
0.8mg/ kg, iv, day 1,8 and 15, every 28 days
Experimental: Arm 2
Drug: BAY80-6946
0.4mg/ kg, iv, day 1,8 and 15, every 28 days
Drug: BAY80-6946
0.8mg/ kg, iv, day 1,8 and 15, every 28 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of subjects with adverse events
Time Frame: 169 days
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
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
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
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
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
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
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
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
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
0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15, 0 - 8 hours in Cycle3 Day 15

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Area under the plasma concentration-time curve of (AUC) of BAY80-6946
Time Frame: 0 - 168 hours in Cycle1 Day1
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
0 - 168 hours in Cycle1 Day1
Mean residence time of drug in plasma (MRT)
Time Frame: 0 - 168 hours in Cycle1 Day1
0 - 168 hours in Cycle1 Day1
Total body clearance of drug from plasma (CL)
Time Frame: 0 - 168 hours in Cycle1 Day1
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
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
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
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
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
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
176 days
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
176 days
Time to progression of cancer growth
Time Frame: 176 days
176 days
Progression-free survival time
Time Frame: 176 days
176 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 18, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 22, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 12, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 14, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15205

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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