Sorafenib Phase II Study for Japanese Anaplastic or Medullary Thyroid Carcinoma Patients
NCT ID: NCT02114658
Last Updated: 2017-08-03
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
PHASE2
18 participants
INTERVENTIONAL
2014-04-15
2016-08-02
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
Sorafenib 400 mg bid continuous dose
Sorafenib (Nexavar,BAY43-9006)
Sorafenib 400 mg will be administered orally,twice daily in a 28 day cycle
Interventions
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Sorafenib (Nexavar,BAY43-9006)
Sorafenib 400 mg will be administered orally,twice daily in a 28 day cycle
Eligibility Criteria
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Inclusion Criteria
* Not a candidate for surgery or radiotherapy with curative intent
* Histologically or cytologically confirmed ATC or MTC
* Measurable or non-measurable disease (but clinically evaluable) according to RECIST 1.1.
* Age \>= 18 years
* Adequate bone marrow, liver and renal function to be conducted within 14 days prior to treatment
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
* Life expectancy of at least 12 weeks
Exclusion Criteria
* Prior anti-cancer treatment with tyrosine kinase inhibitors, monoclonal antibodies (licensed or investigational) that target VEGF or VEGF (vascular endothelial growth factor) receptors or other targeted agents
* Prior chemotherapy for thyroid cancer (only one regimen is allowed)
* Major surgery, open biopsy, or significant traumatic injury within 30 days prior to enrollment in the study.
* Subjects with tracheal, bronchial or esophageal infiltration with significant risk of bleeding but without having received local treatment prior to enrollment in the study
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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Kobe, Hyōgo, Japan
Matsumoto, Nagano, Japan
Bunkyo-ku, Tokyo, Japan
Koto-ku, Tokyo, Japan
Osaka, , Japan
Countries
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Other Identifiers
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17073
Identifier Type: -
Identifier Source: org_study_id
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