Japanese BAY86-9766 Monotherapy Phase I Study

NCT01179295 | Completed Phase 1 DMC

• 1 other identifier: 15091
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neoplasms

Keywords

MEK inhibitor; BAY86-9766; RDEA 119; Solid tumor

Outcome Measures

Primary Outcomes (2)

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

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

• Calculation of pharmacokinetic parameters of BAY86-9766 and its metabolite (M17).

  Cycle 1 Day 22 and Day 23 for Cohorts 1 & 2 and Cohorts 3 & 4, respectively.

Secondary Outcomes (2)

• Response rate

  On average 3 months

• Disease control rate

  On average 3 months

Study Arms (4)

Arm 1

EXPERIMENTAL

Drug: BAY86-9766

Arm 2

EXPERIMENTAL

Drug: BAY86-9766

Arm 3

EXPERIMENTAL

Drug: BAY86-9766

Arm 4

EXPERIMENTAL

Drug: BAY86-9766

Interventions

BAY86-9766 DRUG

BAY86-9766 30 mg twice a day (bid).

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Kashiwa, Chiba, 277-8577, Japan

Location

MeSH Terms

Conditions

Neoplasms

Interventions

N-(3,4-difluoro-2-(2-fluoro-4-iodophenylamino)-6-methoxyphenyl)-1-(2,3-dihydroxypropyl)cyclopropane-1-sulfonamide

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2010
• First Posted: August 11, 2010
• Study Start: November 19, 2010
• Primary Completion: April 27, 2012
• Study Completion: April 27, 2012
• Last Updated: June 20, 2017

Record last verified: 2017-06

Locations

JP (1)