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NCT Number: NCT01764828

BAY86-9766 Plus Gemcitabine Phase I Study in Asian

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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Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Refametinib (BAY86-9766)

Drug

Gemcitabine

Drug

Primary outcomes

  1. Plasma concentration of BAY86-9766

    Time frame: Multiple time points up to 6 day

  2. Plasma concentration of M17 and M11

    Time frame: Multiple time points up to 6 day

  3. Plasma concentration of Gemcitabine

    Time frame: Multiple time points up to 6 day

  4. Plasma concentration of dFdU

    Time frame: Multiple time points up to 6 day

  5. Number of adverse events, or abnormal parameters as a measure of safety and tolerability

    Time frame: Up to 1 year

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

Secondary outcomes

  1. Efficacy of BAY86-9766 shown by a discrete scale

    Time frame: Up to 1 year

    Elements of the scale are :Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jan 10, 2013
Registry last updated
Nov 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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