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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01096030
First received: March 29, 2010
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Neoplasms
Drug: Regorafenib (Stivarga, BAY73-4506)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Pharmacokinetics as measured by cmax and AUC [ Time Frame: Cycle 0, Day 1-5,Cycle 1 Day 1,8,15,21,Cycle 2 Day 1,Modified Dosing Cycle Day 21 ] [ Designated as safety issue: No ]
  • Adverse Event collection [ Time Frame: every 1-2 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Objective tumor response rate [ Time Frame: Every 8 weeks for the first 6 cycles, afterwards every 12 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Exploratory biomarker analysis [ Time Frame: Screening, Cycle 0 or 1 ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: July 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096030

Locations
Hong Kong
Shatin, N.T, Hong Kong
Hong Kong, Hong Kong
Singapore
Singapore, Singapore, 169610
Singapore, Singapore, 119228
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01096030     History of Changes
Other Study ID Numbers: 14996
Study First Received: March 29, 2010
Last Updated: November 18, 2013
Health Authority: Singapore: Health Sciences Authority
Hong Kong: Department of Health

Keywords provided by Bayer:
Regorafenib
Advanced
Refractory solid tumors

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014