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

NCT ID: NCT01096030

Last Updated: 2013-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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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

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Conditions

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Neoplasms

Keywords

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Regorafenib Advanced Refractory solid tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

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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

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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

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Shatin, N.T, Hong Kong

Site Status

Hong Kong, , Hong Kong

Site Status

Singapore, , Singapore

Site Status

Singapore, , Singapore

Site Status

Countries

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Hong Kong Singapore

Other Identifiers

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14996

Identifier Type: -

Identifier Source: org_study_id