BAY86-9766 Plus Gemcitabine Phase I Study in Asian

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-05

Study Completion Date

2015-02-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Refametinib (BAY86-9766)+ Gemcitabine

Single dose of BAY86-9766 on Cycle 1 Day -17; twice daily dosing every day starting on day -14, start dose 50mg bid ( 30mg or 20mg are possible based on adverse events need) in addition with Gemcitabine intravenous on day 1,8 and 15 1000mg/m2

Group Type EXPERIMENTAL

Refametinib (BAY86-9766)

Intervention Type DRUG

Gemcitabine

Intervention Type DRUG

Interventions

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Refametinib (BAY86-9766)

Intervention Type DRUG

Gemcitabine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No