BAY86-9766 Plus Gemcitabine Phase I Study in Asian

This study is currently recruiting participants.
Verified March 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01764828
First received: January 8, 2013
Last updated: March 21, 2014
Last verified: March 2014
  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)


Estimated Enrollment: 22
Study Start Date: February 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764828

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01764828     History of Changes
Other Study ID Numbers: 14747
Study First Received: January 8, 2013
Last Updated: March 21, 2014
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:
Neoplasms
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on April 16, 2014