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

NCT ID: NCT01096030

Last Updated: 2013-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-11-30

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.

Conditions

Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Regorafenib

Group Type: EXPERIMENTAL

Regorafenib (Stivarga, BAY73-4506)

Intervention Type: DRUG

160 mg oral once daily BAY 73-4506 for 3 weeks of every 4 week cycle (i.e. 3 weeks on, 1 week off)

Interventions

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)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Shatin, N.T, Hong Kong

Hong Kong, , Hong Kong

Singapore, , Singapore

Singapore, , Singapore

Countries

Hong Kong; Singapore

Other Identifiers

14996

Identifier Type: -

Identifier Source: org_study_id