Japanese BAY86-9766 Monotherapy Phase I Study

June 19, 2017 updated by: Bayer

Phase 1 Study of Single Agent BAY86-9766 in Japanese Patients With Advanced or Refractory Solid Tumors

This is an uncontrolled, open-label, non-randomized phase I / pharmacokinetic study of oral BAY86-9766 to investigate the safety, tolerability, pharmacokinetics, and efficacy profiles in Japanese patients with advanced solid tumors

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • 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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Japanese patients, who are at least 18 years of age at the first screening examination/ visit, with advanced or refractory solid tumors not amenable to standard therapy.
  • Histological or cytological documentation of non-hematologic, malignant solid tumor, excluding primary brain or spinal tumors, with no current involvement in the central nervous system (CNS)
  • At least one measurable lesion or evaluable disease according to response evaluation criteria in solid tumors (RECIST) version 1.1
  • Eastern cooperative oncology group performance status (ECOG-PS) of 0 or 1
  • Life expectancy of at least 12 weeks

Exclusion Criteria:

  • Use of any anti-cancer therapy including chemotherapy, investigational agents or devices and immunotherapy within 4 weeks of the first dose of study medication
  • Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management
  • Known human immunodeficiency virus (HIV) infection or chronic active hepatitis B or C
  • Inadequate bone marrow, liver and renal function
  • Inability to swallow oral medications or any condition that could affect the absorption of orally administered drugs
  • Concomitant treatment with cytochrome P450 isoenzymes CYP3A4 inhibitors/inducers, and CYP2C19 inhibitors/ inducers

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: BAY86-9766
BAY86-9766 30 mg twice a day (bid).
Drug: BAY86-9766
BAY86-9766 50 mg twice a day (bid).
Drug: BAY86-9766
BAY86-9766 100 mg once a day (od)
Drug: BAY86-9766
BAY86-9766 60 mg once a day (od)
Experimental: Arm 2
Drug: BAY86-9766
BAY86-9766 30 mg twice a day (bid).
Drug: BAY86-9766
BAY86-9766 50 mg twice a day (bid).
Drug: BAY86-9766
BAY86-9766 100 mg once a day (od)
Drug: BAY86-9766
BAY86-9766 60 mg once a day (od)
Experimental: Arm 3
Drug: BAY86-9766
BAY86-9766 30 mg twice a day (bid).
Drug: BAY86-9766
BAY86-9766 50 mg twice a day (bid).
Drug: BAY86-9766
BAY86-9766 100 mg once a day (od)
Drug: BAY86-9766
BAY86-9766 60 mg once a day (od)
Experimental: Arm 4
Drug: BAY86-9766
BAY86-9766 30 mg twice a day (bid).
Drug: BAY86-9766
BAY86-9766 50 mg twice a day (bid).
Drug: BAY86-9766
BAY86-9766 100 mg once a day (od)
Drug: BAY86-9766
BAY86-9766 60 mg once a day (od)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety evaluation due to results of physical examinations, vital signs, AEs, abnormal laboratory tests and 12-lead ECG, cardiac function test and ophthalmological examination.
Time Frame: At the end of 30-day follow up after discontinuation of study drug administration
At the end of 30-day follow up after discontinuation of study drug administration
Calculation of pharmacokinetic parameters of BAY86-9766 and its metabolite (M17).
Time Frame: Cycle 1 Day 22 and Day 23 for Cohorts 1 & 2 and Cohorts 3 & 4, respectively.
Cycle 1 Day 22 and Day 23 for Cohorts 1 & 2 and Cohorts 3 & 4, respectively.

Secondary Outcome Measures

Outcome Measure
Time Frame
Response rate
Time Frame: On average 3 months
On average 3 months
Disease control rate
Time Frame: On average 3 months
On average 3 months

Collaborators and Investigators

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

Sponsor

Bayer

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)

November 19, 2010

Primary Completion (Actual)

April 27, 2012

Study Completion (Actual)

April 27, 2012

Study Registration Dates

First Submitted

August 10, 2010

First Submitted That Met QC Criteria

August 10, 2010

First Posted (Estimate)

August 11, 2010

Study Record Updates

Last Update Posted (Actual)

June 20, 2017

Last Update Submitted That Met QC Criteria

June 19, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 15091

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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