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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01096030

Enrollment

Registered

2010-03-30

Start date

2010-07-31

Completion date

2012-11-30

Last updated

2013-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Keywords

Regorafenib, Advanced, Refractory solid tumors

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.

Interventions

DRUGRegorafenib (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)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

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

Other

Measure	Time frame
Exploratory biomarker analysis	Screening, Cycle 0 or 1

Countries

Hong Kong, Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026