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

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: Regorafenib (Stivarga, BAY73-4506)

• Registration Number: NCT01096030
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-29
• Study First Submitted QC: 2010-03-29
• Study First Posted: 2010-03-30
• Study Start: 2010-07
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-18
• Last Update Posted: 2013-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Regorafenib	Regorafenib (Stivarga, BAY73-4506)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Objective tumor response rate	Every 8 weeks for the first 6 cycles, afterwards every 12 weeks