Study 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

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

Trial summary

Enrollment Goal

Trial Dates

November 2010 - April 2012

Phase

Phase 1

Could I Receive a placebo

Products

Refametinib (BAY86-9766)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
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.
Time Frame:
At the end of 30-day follow up after discontinuation of study drug administration
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.
Safety Issue:
No

Secondary Outcome

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

Additional Information

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