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

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01096030
• Collaborator: (none)
• Enrollment: 33
• Locations: 4
• Arm: 1
• Duration (Months): 28.1
• Patients Per Site: 8.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms	Drug: Regorafenib (Stivarga, BAY73-4506)	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Jul 1, 2010
• Actual Primary Completion Date: Nov 1, 2012
• Actual Study Completion Date: Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Regorafenib	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)

Outcome Measures

Primary Outcome Measures

1. 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]

2. Adverse Event collection [every 1-2 weeks]

Secondary Outcome Measures

1. Objective tumor response rate [Every 8 weeks for the first 6 cycles, afterwards every 12 weeks]

Other Outcome Measures

1. Exploratory biomarker analysis [Screening, Cycle 0 or 1]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Shatin	N.T	Hong Kong
2		Hong Kong		Hong Kong
3		Singapore		Singapore	119228
4		Singapore		Singapore	169610

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT01096030
• Other Study ID Numbers: 14996
• First Posted: Mar 30, 2010
• Last Update Posted: Nov 19, 2013
• Last Verified: Nov 1, 2013

• Keywords provided by Bayer: Regorafenib; Advanced; Refractory solid tumors

Study Results

No Results Posted as of Nov 19, 2013