Clinical trial · Interventional
Sorafenib Phase II Study for Japanese Anaplastic or Medullary Thyroid Carcinoma Patients
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
NCT02114658CI-TRIAL-00028935completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Carcinoma | Thyroid Gland Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sorafenib (Nexavar,BAY43-9006) | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Sorafenib 400 mg bid continuous dose
- interventionNames
- Drug: Sorafenib (Nexavar,BAY43-9006)
Primary outcomes (6)
- measure
- Number of subjects with adverse events and serious adverse events as a measure of safety and tolerability
- timeFrame
- 6 months
- measure
- Change in red blood cell count
- timeFrame
- Baseline and 6 months
- measure
- Change in white blood cell count
- timeFrame
- Baseline and 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.