BAY86-9766 Plus Gemcitabine Phase I Study in Asian

Bayer23 enrolled

Overview

This is an open-label, uncontrolled, Phase Ib study designed to evaluate the safety, tolerability, and pharmacokinetics of BAY86-9766 when given as a single agent and in combination with gemcitabine in Asian patients with advanced or refractory solid tumors.Blood samples for PK (pharmacokinetics) analyses will be collected after a single dose of BAY86-9766, multiple doses of BAY86-9766, and combination treatment of gemcitabine and BAY86-9766. Safety evaluation will include adverse events assessment, vital signs, laboratory tests, 12-lead ECG ECG (electrocardiography), cardiac function test, and ophthalmologic examination at various time points during the study.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Neoplasms

Interventions

Refametinib (BAY86-9766)DRUG

GemcitabineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female patients \>/= 18 years of age, with histologically or cytologically documented advanced or refractory solid tumors not amenable to standard therapy * Patients must have at least one measurable or evaluable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 * Patients must have a life expectancy of at least 12 weeks, and an Eastern Cooperative Oncology Group Performance Status (ECOG PS) \</=1. Exclusion Criteria: * History of cardiac disease * Active clinically serious infections \> Common Terminology Criteria for Adverse Events (CTCAE) grade 2 * Known human immunodeficiency virus (HIV) infection * Uncontrolled seizure disorder * Undergoing renal dialysis * Known bleeding diathesis * History of organ allograft * Pregnant or breast feeding women

Locations (3)

Unnamed facility

Shanghai, China

Unnamed facility

Kashiwa, Chiba, Japan

Unnamed facility

Seoul, South Korea

Outcomes

Primary Outcomes

Plasma concentration of BAY86-9766

Time frame: Multiple time points up to 6 day

Plasma concentration of M17 and M11

Time frame: Multiple time points up to 6 day

Plasma concentration of Gemcitabine

Time frame: Multiple time points up to 6 day

Plasma concentration of dFdU

Time frame: Multiple time points up to 6 day

Number of adverse events, or abnormal parameters as a measure of safety and tolerability

Parameters are laboratory parameters, vital signs, ECG parameters, cardiac function, and parameters of ophthalmologic examinations

Time frame: Up to 1 year

Secondary Outcomes

Efficacy of BAY86-9766 shown by a discrete scale

Elements of the scale are :Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD)

Time frame: Up to 1 year

Data from ClinicalTrials.gov

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