Japanese BAY86-9766 Monotherapy Phase I Study

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01179295
First received: August 10, 2010
Last updated: May 7, 2013
Last verified: May 2013
  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


Condition Intervention Phase
Neoplasms
Drug: BAY86-9766
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of Single Agent BAY86-9766 in Japanese Patients With Advanced or Refractory Solid Tumors

Resource links provided by NLM:


Further study details as provided by Bayer:

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

Secondary Outcome Measures:
  • Response rate [ Time Frame: On average 3 months ] [ Designated as safety issue: No ]
  • Disease control rate [ Time Frame: On average 3 months ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: November 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: BAY86-9766
BAY86-9766 30 mg twice a day (bid).
Experimental: Arm 2 Drug: BAY86-9766
BAY86-9766 50 mg twice a day (bid).
Experimental: Arm 3 Drug: BAY86-9766
BAY86-9766 100 mg once a day (od)
Experimental: Arm 4 Drug: BAY86-9766
BAY86-9766 60 mg once a day (od)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01179295

Locations
Japan
Kashiwa, Chiba, Japan, 277-8577
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Head Clinical Pharmacology, Bayer Yakuhin, Ltd
ClinicalTrials.gov Identifier: NCT01179295     History of Changes
Other Study ID Numbers: 15091
Study First Received: August 10, 2010
Last Updated: May 7, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Bayer:
MEK inhibitor
BAY86-9766
RDEA 119
Solid tumor

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014