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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01096030
• Other study ID #: 14996
• Status: Completed
• Phase: Phase 1
• First received: March 29, 2010
• Last updated: November 18, 2013
• Start date: July 2010
• Est. completion date: November 2012

Study information

• Verified date: November 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences AuthorityHong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Hong Kong,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory biomarker analysis		Screening, Cycle 0 or 1	No
Primary	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	No
Primary	Adverse Event collection		every 1-2 weeks	Yes
Secondary	Objective tumor response rate		Every 8 weeks for the first 6 cycles, afterwards every 12 weeks	No

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