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
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: 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

ClinicalTrials.gov processed this record on October 23, 2014