Sorafenib Phase II Study for Japanese Anaplastic or Medullary Thyroid Carcinoma Patients

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Brief Title

Sorafenib Phase II Study for Japanese Anaplastic or Medullary Thyroid Carcinoma Patients

Official Title

A Multi-center, Single-arm, Open-label Phase II Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Sorafenib in Japanese Patients With Anaplastic Thyroid Carcinoma or Locally Advanced or Metastatic Medullary Thyroid Carcinoma

Brief Summary

      The objectives of this study are to evaluate safety, efficacy and pharmacokinetics of
      sorafenib for the treatment of Japanese patients with anaplastic thyroid carcinoma (ATC) or
      locally advanced or metastatic medullary thyroid carcinoma (MTC).
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Number of subjects with adverse events and serious adverse events as a measure of safety and tolerability

Secondary Outcome

 Best overall response based on RECIST 1.1 criteria

Condition

Thyroid Carcinoma

Intervention

Sorafenib (Nexavar,BAY43-9006)

Study Arms / Comparison Groups

 Arm 1
Description:  Sorafenib 400 mg bid continuous dose

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

18

Start Date

April 15, 2014

Completion Date

August 2, 2016

Primary Completion Date

February 23, 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Japanese patients with ATC (Anaplastic thyroid carcinoma) or locally advanced or
             metastatic MTC (medullary thyroid carcinoma)

          -  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:

          -  Histologic subtypes of thyroid cancer other than anaplastic or medullary carcinoma

          -  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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Bayer Study Director, , 

Location Countries

Japan

Location Countries

Japan

Administrative Informations


NCT ID

NCT02114658

Organization ID

17073


Responsible Party

Sponsor

Study Sponsor

Bayer


Study Sponsor

Bayer Study Director, Study Director, Bayer


Verification Date

August 2017