Thyroid Carcinoma
Conditions
Keywords
Anaplastic and medullary thyroid carcinoma, Thyroid Neoplasms
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).
Interventions
DRUGSorafenib (Nexavar,BAY43-9006)
Sorafenib 400 mg will be administered orally,twice daily in a 28 day cycle
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in alanine aminotransaminase level (ALT) | Baseline and 6 months |
| Change in aspartate aminotransferase level (AST) | Baseline and 6 months |
| Change in blood pressure | Baseline and 6 months |
| Change in white blood cell count | Baseline and 6 months |
| Number of subjects with adverse events and serious adverse events as a measure of safety and tolerability | 6 months |
| Change in red blood cell count | Baseline and 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum reduction from baseline in the target lesion size | Baseline and every 56 days up to progressive disease | — |
| Progression-free survival (PFS) | Baseline to progression or death by any reason | — |
| Maximum percentage change of calcitonin and Carcinoembryonic antigen (CEA) values from baseline | Baseline and every 56 days up to progressive disease | MTC subjects only |
| Overall survival (OS) | Baseline to death by any reason | — |
| Response rate (RR) | Baseline and every 56 days up to progressive disease | RR based on RECIST 1.1 criteria |
| Disease control rate (DCR) | Baseline and every 56 days up to progressive disease | DCR based on RECIST 1.1 criteria |
| Best overall response based on RECIST 1.1 criteria | Baseline and every 56 days up to progressive disease,an expected average of 8 months | — |
| Plasma concentration of sorafenib | Cycle 2 Day 1 | — |
Countries
Japan
Outcome results
None listed