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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00960258
First received: July 3, 2009
Last updated: March 11, 2013
Last verified: March 2013
History of Changes
  Purpose

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: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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:

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

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). ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Biomarker [ Time Frame: At screening ] [ Designated as safety issue: No ]
  • Response rate [ Time Frame: Every 8 weeks for the first 6 cycles. After Cycle 6, every 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: July 2009
Estimated Study Completion Date: March 2014
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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00960258

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

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Head of Clinical Sciences, Bayer Yakuhin Ltd.
ClinicalTrials.gov Identifier: NCT00960258     History of Changes
Other Study ID Numbers: 13172
Study First Received: July 3, 2009
Last Updated: March 11, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Bayer:
Solid Tumors

ClinicalTrials.gov processed this record on May 16, 2013