BAY86-9766 Plus Gemcitabine Phase I Study in Asian

A Multi-center, Phase Ib Study of MEK (Mitogen Activated Protein Kinase/ERK Kinase) Inhibitor BAY86-9766 Plus Gemcitabine in Asian Patients With Advanced or Refractory Solid Tumors

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01764828

Enrollment

Registered

2013-01-10

Start date

2013-02-05

Completion date

2015-02-10

Last updated

2018-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Keywords

Phase I, Pharmacokinetics, Safety measurements

Brief summary

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.

Interventions

DRUGRefametinib (BAY86-9766)

DRUGGemcitabine

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Plasma concentration of BAY86-9766	Multiple time points up to 6 day	—
Plasma concentration of M17 and M11	Multiple time points up to 6 day	—
Plasma concentration of Gemcitabine	Multiple time points up to 6 day	—
Plasma concentration of dFdU	Multiple time points up to 6 day	—
Number of adverse events, or abnormal parameters as a measure of safety and tolerability	Up to 1 year	Parameters are laboratory parameters, vital signs, ECG parameters, cardiac function, and parameters of ophthalmologic examinations

Secondary

Measure	Time frame	Description
Efficacy of BAY86-9766 shown by a discrete scale	Up to 1 year	Elements of the scale are :Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD)

Countries

China, Japan, South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026