Japanese BAY86-9766 Monotherapy Phase I Study

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: BAY86-9766

• Registration Number: NCT01179295
• Lead Sponsor: Bayer

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-10
• Study First Submitted QC: 2010-08-10
• Study First Posted: 2010-08-11
• Study Start: 2010-11-19
• Primary Completion: 2012-04-27
• Study Completion: 2012-04-27
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-19
• Last Update Posted: 2017-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 4	BAY86-9766	-
Arm 3	BAY86-9766	-
Arm 1	BAY86-9766	-
Arm 2	BAY86-9766	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Response rate	On average 3 months
Disease control rate	On average 3 months