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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01096030
Recruitment Status : Completed
First Posted : March 30, 2010
Last Update Posted : November 19, 2013
Information provided by (Responsible Party):

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

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Study Type : Interventional  (Clinical Trial)
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 : July 2010
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Regorafenib

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)

Primary Outcome Measures :
  1. 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 ]
  2. Adverse Event collection [ Time Frame: every 1-2 weeks ]

Secondary Outcome Measures :
  1. Objective tumor response rate [ Time Frame: Every 8 weeks for the first 6 cycles, afterwards every 12 weeks ]

Other Outcome Measures:
  1. Exploratory biomarker analysis [ Time Frame: Screening, Cycle 0 or 1 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01096030

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Hong Kong
Shatin, N.T, Hong Kong
Hong Kong, Hong Kong
Singapore, Singapore, 119228
Singapore, Singapore, 169610
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer
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Responsible Party: Bayer Identifier: NCT01096030    
Other Study ID Numbers: 14996
First Posted: March 30, 2010    Key Record Dates
Last Update Posted: November 19, 2013
Last Verified: November 2013
Keywords provided by Bayer:
Refractory solid tumors