Study Completed

Neoplasms

Bayer Identifier:

14747

ClinicalTrials.gov Identifier:

NCT01764828

EudraCT Number:

Not Available

EU CT Number:

Not Available

BAY86-9766 plus gemcitabine Phase I study in Asian

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 Years

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)
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

Trial summary

Enrollment Goal

Trial Dates

February 2013 - February 2015

Phase

Phase 1

Could I Receive a placebo

Products

Refametinib (BAY86-9766)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Kashiwa, 277-8577, Japan
Completed		shanghai, 200032, China
Completed		Seoul, 03080, Korea, Republic Of

Primary Outcome

Plasma concentration of BAY86-9766
Time Frame:
Multiple time points up to 6 day
Safety Issue:
No
Plasma concentration of M17 and M11
Time Frame:
Multiple time points up to 6 day
Safety Issue:
No
Plasma concentration of Gemcitabine
Time Frame:
Multiple time points up to 6 day
Safety Issue:
No
Plasma concentration of dFdU
Time Frame:
Multiple time points up to 6 day
Safety Issue:
No
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
Safety Issue:
Yes

Secondary Outcome

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
Safety Issue:
No

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Other

Allocation

N/A

Blinding

Open Label

Assignment

Single Group Assignment

Trial Arms

Additional Information

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