Phase I Study of BAY73-4506 in Chinese Patients With Advanced, Refractory Solid Tumors

Study Overview
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Brief Summary
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This will be an uncontrolled, open-label, non-randomized, phase I study. The primary objectives of this study are to define the pharmacokinetics (PK) and to evaluate the safety and tolerability of Regorafenib administered orally as a single agent in Chinese patients with advanced solid tumors. The secondary objectives are to evaluate tumor response of patients treated with Regorafenib.

Official Title
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Uncontrolled, Open-label, Non-randomized, Phase 1 Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of BAY73-4506 in Chinese Patients With Advanced, Refractory Solid Tumors

Conditions
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Neoplasms

Intervention / Treatment
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* Drug: Regorafenib (Stivarga, BAY73-4506)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female Chinese subjects >/- 18 years Advanced, histologically or cytologically confirmed solid tumors Subjects malignancies must be refractory to standard treatment or have no standard therapy available, or the subject actively refused any treatment that would be regarded standard, and/or if, in the judgment of the investigator or his/her designated associate(s), experimental treatment is clinically and ethically acceptable. Eastern Cooperative Oncology Group performance status (ECOG-PS) 0-1; Adequate bone marrow, liver and renal function Life expectancy of at least 3 months Exclusion Criteria: Unstable/uncontrolled cardiac disease History of arterial or venous thrombotic or embolic events Malabsorption condition Severe renal impairment; persistent proteinuria >/= Grade 3 Symptomatic metastatic brain or meningeal tumors Clinically significant bleeding >/=Grade 3 within 30 days before start of study medication.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regorafenib<br> | Drug: Regorafenib (Stivarga, BAY73-4506)<br>* 160 mg oral once daily BAY 73-4506 for 3 weeks of every 4 week cycle (i.e. 3 weeks on, 1 week off)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics as measured by cmax and AUC |  | Cycle 0, Day 1-5,Cycle 1 Day 1,8,15,21,Cycle 2 Day 1,Modified Dosing Cycle Day 21 | 
| Adverse Event collection |  | every 1-2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective tumor response rate |  | Every 8 weeks for the first 6 cycles, afterwards every 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Regorafenib, Advanced, Refractory solid tumors