Trial Condition(s):

Thyroid carcinoma

Sorafenib Phase II study for Japanese anaplastic or medullary thyroid carcinoma patients

Bayer Identifier:

17073

ClinicalTrials.gov Identifier:

NCT02114658

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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).

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

Trial Summary

Enrollment Goal
18
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Bunkyo-ku, Japan, 113-8603

Status
Completed
 
Locations

Investigative Site

Koto-ku, Japan, 135-8550

Status
Completed
 
Locations

Investigative Site

Osaka, Japan, 545-8586

Status
Completed
 
Locations

Investigative Site

Matsumoto, Japan, 390-8621

Status
Completed
 
Locations

Investigative Site

Kobe, Japan, 650-0011

Status
Completed
 

Trial Design