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

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

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.

Study Overview

• Status: Completed
• Conditions: Neoplasms
• Intervention / Treatment: Drug: Regorafenib (Stivarga, BAY73-4506)

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
  • N.T
    • Shatin, N.T, Hong Kong
• Singapore
  • Singapore, Singapore, 119228
  • Singapore, Singapore, 169610

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Exploratory biomarker analysis	Screening, Cycle 0 or 1

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: March 29, 2010
• First Submitted That Met QC Criteria: March 29, 2010
• First Posted (Estimate): March 30, 2010

Study Record Updates

• Last Update Posted (Estimate): November 19, 2013
• Last Update Submitted That Met QC Criteria: November 18, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Advanced; Regorafenib; Refractory solid tumors
• Other Study ID Numbers: 14996