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

Phase 1

Completed

• Conditions: Tumors
• Interventions: Drug: Regorafenib (BAY73-4506)

• Registration Number: NCT00960258
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-07-01
• Study First Submitted: 2009-07-03
• Study First Submitted QC: 2009-08-14
• Study First Posted: 2009-08-17
• Primary Completion: 2010-04-26
• Study Completion: 2013-11-11
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-26
• Last Update Posted: 2017-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Regorafenib (BAY73-4506)	-

Primary Outcome Measures

Name	Time	Method
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	After 5 weeks (after Cycle 1).

Secondary Outcome Measures

Name	Time	Method
Biomarker	At screening
Response rate	Every 8 weeks for the first 6 cycles. After Cycle 6, every 12 weeks