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