BAY86-9766 Plus Gemcitabine Phase I Study in Asian

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: Refametinib (BAY86-9766); Drug: Gemcitabine

• Registration Number: NCT01764828
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-08
• Study First Submitted QC: 2013-01-09
• Study First Posted: 2013-01-10
• Study Start: 2013-02-05
• Primary Completion: 2014-12-18
• Study Completion: 2015-02-10
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-31
• Last Update Posted: 2018-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Refametinib (BAY86-9766)+ Gemcitabine	Refametinib (BAY86-9766)	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
Refametinib (BAY86-9766)+ Gemcitabine	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

Primary Outcome Measures

Name	Time	Method
Plasma concentration of M17 and M11	Multiple time points up to 6 day
Plasma concentration of BAY86-9766	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 Outcome Measures

Name	Time	Method
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)