Japanese BAY86-9766 Monotherapy Phase I Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-19

Study Completion Date

2012-04-27

Brief Summary

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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

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Detailed Description

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Conditions

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Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

BAY86-9766

Intervention Type DRUG

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

Arm 2

Group Type EXPERIMENTAL

BAY86-9766

Intervention Type DRUG

BAY86-9766 50 mg twice a day (bid).

Arm 3

Group Type EXPERIMENTAL

BAY86-9766

Intervention Type DRUG

BAY86-9766 100 mg once a day (od)

Arm 4

Group Type EXPERIMENTAL

BAY86-9766

Intervention Type DRUG

BAY86-9766 60 mg once a day (od)

Interventions

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BAY86-9766

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

Intervention Type DRUG

BAY86-9766

BAY86-9766 50 mg twice a day (bid).

Intervention Type DRUG

BAY86-9766

BAY86-9766 100 mg once a day (od)

Intervention Type DRUG

BAY86-9766

BAY86-9766 60 mg once a day (od)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No