BAY86-9766 Plus Gemcitabine Phase I Study in Asian

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01764828
• Other study ID #: 14747
• Status: Completed
• Phase: Phase 1
• Start date: February 5, 2013
• Est. completion date: February 10, 2015

Study information

• Verified date: October 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 10, 2015
• Est. primary completion date: December 18, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• Refametinib (BAY86-9766)

• Gemcitabine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

China,  Japan,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration of BAY86-9766		Multiple time points up to 6 day
Primary	Plasma concentration of M17 and M11		Multiple time points up to 6 day
Primary	Plasma concentration of Gemcitabine		Multiple time points up to 6 day
Primary	Plasma concentration of dFdU		Multiple time points up to 6 day
Primary	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	Up to 1 year
Secondary	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)	Up to 1 year

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