check_circleStudy 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
  • - 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)
  • - 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
23
Trial Dates
February 2013 - February 2015
Phase
Phase 1
Could I Receive a placebo
No
Products
Refametinib (BAY86-9766)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Kashiwa, 277-8577, Japan
Completed
shanghai, 200032, China
Completed
Seoul, 03080, Korea, Republic Of

Primary Outcome

  • Plasma concentration of BAY86-9766
    date_rangeTime Frame:
    Multiple time points up to 6 day
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of M17 and M11
    date_rangeTime Frame:
    Multiple time points up to 6 day
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of Gemcitabine
    date_rangeTime Frame:
    Multiple time points up to 6 day
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of dFdU
    date_rangeTime Frame:
    Multiple time points up to 6 day
    enhanced_encryption
    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
    date_rangeTime Frame:
    Up to 1 year
    enhanced_encryption
    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)
    date_rangeTime Frame:
    Up to 1 year
    enhanced_encryption
    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
1

Additional Information

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