Phase I Study to Investigate Pharmacokinetics and Safety of BAY73-4506 in Asian (Japanese) Patients With Solid Tumors.

Bayer15 enrolled

Overview

This study is to define the pharmacokinetics and to evaluate the safety of BAY73-4506, 160 mg once daily administered orally as a single agent in Japanese patients with advanced solid tumors.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tumors

Interventions

Regorafenib (BAY73-4506)DRUG

The patients will be treated on Day 1 of the first week followed by 6 days off treatment (Cycle 0, single dosing period). After Cycle 0, the patients will be treated with BAY 73-4506 (160 mg once daily orally, 21 days on/ 7 days off schedule). Dose level : 160 mgDose level-1: 120 mgDose level-2: 60 mg

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female Japanese patients \>/= 18 years * Histologically or cytologically confirmed solid tumors * ECOG-PS 0 - 1 * Adequate bone marrow, liver and renal function Exclusion Criteria: * Uncontrolled hypertension * Patients with severe renal impairment or on dialysis * Patients with seizure disorder requiring anticonvulsant medication * Known or suspected allergy to the investigational agent.

Locations (4)

Unnamed facility

Kashiwa-shi, Chiba, Japan

Unnamed facility

Hidaka, Saitama, Japan

Unnamed facility

Chuo-ku, Tokyo, Japan

Unnamed facility

Mitaka, Tokyo, Japan

Outcomes

Primary Outcomes

Grade 4 neutropenia for >/= 7 days, febrile neutropenia with Grade 4 neutropenia, Grade 4 thrombocytopenia, Grade 3 or 4 non-hematologic toxicity, hypertension and skin toxicity of Grade 3 or 4 which are not manageable and pharmacokinetics

Time frame: After 5 weeks (after Cycle 1).

Secondary Outcomes

Biomarker

Time frame: At screening

Response rate

Time frame: Every 8 weeks for the first 6 cycles. After Cycle 6, every 12 weeks

Data from ClinicalTrials.gov

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