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Phase I Study to Investigate Pharmacokinetics and Safety of BAY73-4506 in Asian (Japanese) Patients With Solid Tumors.

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: July 3, 2009
Last updated: November 19, 2013
Last verified: November 2013
This study is to define the pharmacokinetics and to evaluate the safety of BAY73-4506, 160 mg once daily administered orally as a single agent in Japanese patients with advanced solid tumors.

Condition Intervention Phase
Tumors Drug: Regorafenib (BAY73-4506) Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I, Uncontrolled, Open-label, Non-randomized Study to Investigate Pharmacokinetics and Safety of BAY73-4506 in Asian (Japanese) Patients With Advanced, Refractory Solid Tumors

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Grade 4 neutropenia for >/= 7 days, febrile neutropenia with Grade 4 neutropenia, Grade 4 thrombocytopenia, Grade 3 or 4 non-hematologic toxicity, hypertension and skin toxicity of Grade 3 or 4 which are not manageable and pharmacokinetics [ Time Frame: After 5 weeks (after Cycle 1). ]

Secondary Outcome Measures:
  • Biomarker [ Time Frame: At screening ]
  • Response rate [ Time Frame: Every 8 weeks for the first 6 cycles. After Cycle 6, every 12 weeks ]

Enrollment: 15
Study Start Date: July 2009
Study Completion Date: October 2013
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Regorafenib (BAY73-4506)
The patients will be treated on Day 1 of the first week followed by 6 days off treatment (Cycle 0, single dosing period). After Cycle 0, the patients will be treated with BAY 73-4506 (160 mg once daily orally, 21 days on/ 7 days off schedule). Dose level : 160 mgDose level-1: 120 mgDose level-2: 60 mg


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female Japanese patients >/= 18 years
  • Histologically or cytologically confirmed solid tumors
  • ECOG-PS 0 - 1
  • Adequate bone marrow, liver and renal function

Exclusion Criteria:

  • Uncontrolled hypertension
  • Patients with severe renal impairment or on dialysis
  • Patients with seizure disorder requiring anticonvulsant medication
  • Known or suspected allergy to the investigational agent.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00960258

Kashiwa, Chiba, Japan, 277-8577
Hidaka, Saitama, Japan, 350-1298
Chuo-ku, Tokyo, Japan, 104-0045
Mitaka, Tokyo, Japan, 181-8611
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT00960258     History of Changes
Other Study ID Numbers: 13172
Study First Received: July 3, 2009
Last Updated: November 19, 2013

Keywords provided by Bayer:
Solid Tumors processed this record on September 21, 2017