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

NCT01096030 | Completed Phase 1

• 1 other identifier: 14996
• Study Type: interventional
• Target: 33
• Locations: 2 countries
• Sites: 4

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.

Conditions

Neoplasms

Keywords

Regorafenib; Advanced; Refractory solid tumors

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Objective tumor response rate

  Every 8 weeks for the first 6 cycles, afterwards every 12 weeks

Other Outcomes (1)

• Exploratory biomarker analysis

  Screening, Cycle 0 or 1

Study Arms (1)

Regorafenib

EXPERIMENTAL

Drug: Regorafenib (Stivarga, BAY73-4506)

Interventions

Regorafenib (Stivarga, BAY73-4506) 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)

Regorafenib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (4)

Unknown Facility

Shatin, N.T, Hong Kong

Location

Unknown Facility

Hong Kong, Hong Kong

Location

Unknown Facility

Singapore, 119228, Singapore

Location

Unknown Facility

Singapore, 169610, Singapore

Location

MeSH Terms

Conditions

Neoplasms

Interventions

regorafenib

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2010
• First Posted: March 30, 2010
• Study Start: July 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 19, 2013

Record last verified: 2013-11

Locations

SG (2); HK (2)