Phase I Study to Investigate Pharmacokinetics and Safety of BAY73-4506 in Asian (Japanese) Patients With Solid Tumors.
NCT ID: NCT00960258
Last Updated: 2017-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
15 participants
INTERVENTIONAL
2009-07-01
2013-11-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
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
Interventions
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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 Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed solid tumors
* ECOG-PS 0 - 1
* Adequate bone marrow, liver and renal function
Exclusion Criteria
* Patients with severe renal impairment or on dialysis
* Patients with seizure disorder requiring anticonvulsant medication
* Known or suspected allergy to the investigational agent.
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Kashiwa-shi, Chiba, Japan
Hidaka, Saitama, Japan
Chuo-ku, Tokyo, Japan
Mitaka, Tokyo, Japan
Countries
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Other Identifiers
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13172
Identifier Type: -
Identifier Source: org_study_id