NCT01764828

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2013

Typical duration for phase_1

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 10, 2013

Completed
26 days until next milestone

Study Start

First participant enrolled

February 5, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2015

Completed
Last Updated

November 1, 2018

Status Verified

October 1, 2018

Enrollment Period

1.9 years

First QC Date

January 8, 2013

Last Update Submit

October 31, 2018

Conditions

Neoplasms

Keywords

Phase IPharmacokineticsSafety measurements

Outcome Measures

Primary Outcomes (5)

  • Plasma concentration of BAY86-9766

    Multiple time points up to 6 day

  • Plasma concentration of M17 and M11

    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

    Parameters are laboratory parameters, vital signs, ECG parameters, cardiac function, and parameters of ophthalmologic examinations

    Up to 1 year

Secondary Outcomes (1)

  • Efficacy of BAY86-9766 shown by a discrete scale

    Up to 1 year

Study Arms (1)

Refametinib (BAY86-9766)+ Gemcitabine

EXPERIMENTAL

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

Drug: Refametinib (BAY86-9766)Drug: Gemcitabine

Interventions

Refametinib (BAY86-9766)DRUG
Refametinib (BAY86-9766)+ Gemcitabine
GemcitabineDRUG
Refametinib (BAY86-9766)+ Gemcitabine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Shanghai, 200032, China

Location

Unknown Facility

Kashiwa, Chiba, 277-8577, Japan

Location

Unknown Facility

Seoul, 03080, South Korea

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

N-(3,4-difluoro-2-(2-fluoro-4-iodophenylamino)-6-methoxyphenyl)-1-(2,3-dihydroxypropyl)cyclopropane-1-sulfonamideGemcitabine

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2013

First Posted

January 10, 2013

Study Start

February 5, 2013

Primary Completion

December 18, 2014

Study Completion

February 10, 2015

Last Updated

November 1, 2018

Record last verified: 2018-10

Locations

JP(1)CN(1)KR(1)