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

Bayer

Status and phase

Completed

Phase 2

Conditions

Thyroid Carcinoma

Treatments

Drug: Sorafenib (Nexavar,BAY43-9006)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02114658

17073

Details and patient eligibility

About

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).

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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