check_circleStudy Completed

Neoplasms

Bayer Identifier:

15091

ClinicalTrials.gov Identifier:

NCT01179295

EudraCT Number:

Not Available

EU CT Number:

Not Available
Japanese BAY86-9766 monotherapy Phase I study

Trial purpose

This is an uncontrolled, open-label, non-randomized phase I / pharmacokinetic study of oral BAY86-9766 to investigate the safety, tolerability, pharmacokinetics, and efficacy profiles in Japanese patients with advanced solid tumors

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Japanese patients, who are at least 18 years of age at the first screening examination/ visit, with advanced or refractory solid tumors not amenable to standard therapy.
    - Histological or cytological documentation of non-hematologic, malignant solid tumor, excluding primary brain or spinal tumors, with no current involvement in the central nervous system (CNS)
    - At least one measurable lesion or evaluable disease according to response evaluation criteria in solid tumors (RECIST) version 1.1
    - Eastern cooperative oncology group performance status (ECOG-PS) of 0 or 1
    - Life expectancy of at least 12 weeks
  • - Use of any anti-cancer therapy including chemotherapy, investigational agents or devices and immunotherapy within 4 weeks of the first dose of study medication
    - Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management
    - Known human immunodeficiency virus (HIV) infection or chronic active hepatitis B or C
    - Inadequate bone marrow, liver and renal function
    - Inability to swallow oral medications or any condition that could affect the absorption of orally administered drugs
    - Concomitant treatment with cytochrome P450 isoenzymes CYP3A4 inhibitors/inducers, and CYP2C19 inhibitors/ inducers

Trial summary

Enrollment Goal
12
Trial Dates
November 2010 - April 2012
Phase
Phase 1
Could I Receive a placebo
No
Products
Refametinib (BAY86-9766)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Kashiwa, 277-8577, Japan

Primary Outcome

  • Safety evaluation due to results of physical examinations, vital signs, AEs, abnormal laboratory tests and 12-lead ECG, cardiac function test and ophthalmological examination.
    date_rangeTime Frame:
    At the end of 30-day follow up after discontinuation of study drug administration
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    Safety Issue:
    Yes
  • Calculation of pharmacokinetic parameters of BAY86-9766 and its metabolite (M17).
    date_rangeTime Frame:
    Cycle 1 Day 22 and Day 23 for Cohorts 1 & 2 and Cohorts 3 & 4, respectively.
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    Safety Issue:
    No

Secondary Outcome

  • Response rate
    date_rangeTime Frame:
    On average 3 months
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    Safety Issue:
    No
  • Disease control rate
    date_rangeTime Frame:
    On average 3 months
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    Safety Issue:
    No

Trial design

Phase 1 study of single agent BAY86-9766 in Japanese patients with advanced or refractory solid tumors
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
4

Additional Information

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