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

Bayer

Status and phase

Completed

Phase 1

Conditions

Neoplasms

Treatments

Drug: Regorafenib (Stivarga, BAY73-4506)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01096030

14996

Details and patient eligibility

About

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.

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.