Japanese BAY86-9766 Monotherapy Phase I Study

Study Overview
=================
Brief Summary
-----------------
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

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

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Drug: BAY86-9766
* Drug: BAY86-9766
* Drug: BAY86-9766
* Drug: BAY86-9766


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 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). |  | Cycle 1 Day 22 and Day 23 for Cohorts 1 & 2 and Cohorts 3 & 4, respectively. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | On average 3 months | 
| Disease control rate |  | On average 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MEK inhibitor, BAY86-9766, RDEA 119, Solid tumor