BAY86-9766 Plus Gemcitabine Phase I Study in Asian

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01764828
Recruitment Status : Completed
First Posted : January 10, 2013
Last Update Posted : March 12, 2015
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: Refametinib (BAY86-9766) Drug: Gemcitabine Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Study Start Date : February 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Refametinib (BAY86-9766)+ 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
Drug: Refametinib (BAY86-9766) Drug: Gemcitabine

Primary Outcome Measures :
  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 Outcome Measures :
  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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01764828

Shanghai, China, 200032
Kashiwa, Chiba, Japan, 277-8577
Korea, Republic of
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 110-744
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer Identifier: NCT01764828     History of Changes
Other Study ID Numbers: 14747
First Posted: January 10, 2013    Key Record Dates
Last Update Posted: March 12, 2015
Last Verified: March 2015

Keywords provided by Bayer:
Phase I
Safety measurements

Additional relevant MeSH terms:
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs