BAY86-9766 Plus Gemcitabine Phase I Study in Asian

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01764828
First received: January 8, 2013
Last updated: March 11, 2015
Last verified: March 2015
  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.


Condition Intervention Phase
Neoplasms
Drug: Refametinib (BAY86-9766)
Drug: Gemcitabine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Plasma concentration of BAY86-9766 [ Time Frame: Multiple time points up to 6 day ] [ Designated as safety issue: No ]
  • Plasma concentration of M17 and M11 [ Time Frame: Multiple time points up to 6 day ] [ Designated as safety issue: No ]
  • Plasma concentration of Gemcitabine [ Time Frame: Multiple time points up to 6 day ] [ Designated as safety issue: No ]
  • Plasma concentration of dFdU [ Time Frame: Multiple time points up to 6 day ] [ Designated as safety issue: No ]
  • Number of adverse events, or abnormal parameters as a measure of safety and tolerability [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
    Parameters are laboratory parameters, vital signs, ECG parameters, cardiac function, and parameters of ophthalmologic examinations


Secondary Outcome Measures:
  • Efficacy of BAY86-9766 shown by a discrete scale [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Elements of the scale are :Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD)


Enrollment: 23
Study Start Date: February 2013
Study Completion Date: February 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01764828

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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01764828     History of Changes
Other Study ID Numbers: 14747 
Study First Received: January 8, 2013
Last Updated: March 11, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency
China: Food and Drug Administration
South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Bayer:
Phase I
Pharmacokinetics
Safety measurements

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

ClinicalTrials.gov processed this record on August 29, 2016