Phase I Study to Investigate Pharmacokinetics and Safety of BAY73-4506 in Asian (Japanese) Patients With 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: NCT00960258
Recruitment Status : Completed
First Posted : August 17, 2009
Last Update Posted : September 27, 2017
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Tumors Drug: Regorafenib (BAY73-4506) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
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
Actual Study Start Date : July 1, 2009
Actual Primary Completion Date : April 26, 2010
Actual Study Completion Date : November 11, 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Regorafenib
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Biomarker [ Time Frame: At screening ]
  2. Response rate [ Time Frame: Every 8 weeks for the first 6 cycles. After Cycle 6, every 12 weeks ]

Information from the National Library of Medicine

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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.

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): NCT00960258

Kashiwa-shi, 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

Additional Information:
Responsible Party: Bayer Identifier: NCT00960258     History of Changes
Other Study ID Numbers: 13172
First Posted: August 17, 2009    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: September 2017

Keywords provided by Bayer:
Solid Tumors