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Phase 1 Study of Single Agent BAY86-9766 in Japanese Patients With Advanced or Refractory Solid Tumors

Phase 1
18 Years
Not Enrolling

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Trial Information

Phase 1 Study of Single Agent BAY86-9766 in Japanese Patients With Advanced or Refractory Solid Tumors

Inclusion Criteria:

- 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

- 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

Exclusion Criteria:

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety evaluation due to results of physical examinations, vital signs, AEs, abnormal laboratory tests and 12-lead ECG, cardiac function test and ophthalmological examination.

Outcome Time Frame:

At the end of 30-day follow up after discontinuation of study drug administration

Safety Issue:


Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:



Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

November 2010

Completion Date:

April 2012

Related Keywords:

  • Neoplasms
  • MEK inhibitor
  • BAY86-9766
  • RDEA 119
  • Solid tumor
  • Neoplasms