NCT02114658
Completed
Phase 2
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
ConditionsThyroid Carcinoma
InterventionsSorafenib (Nexavar,BAY43-9006)
Overview
- Phase
- Phase 2
- Intervention
- Sorafenib (Nexavar,BAY43-9006)
- Conditions
- Thyroid Carcinoma
- Sponsor
- Bayer
- Enrollment
- 18
- Primary Endpoint
- Change in white blood cell count
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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).
Investigators
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.
- •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
Arms & Interventions
Arm 1
Sorafenib 400 mg bid continuous dose
Intervention: Sorafenib (Nexavar,BAY43-9006)
Outcomes
Primary Outcomes
Change in white blood cell count
Time Frame: Baseline and 6 months
Change in alanine aminotransaminase level (ALT)
Time Frame: Baseline and 6 months
Change in aspartate aminotransferase level (AST)
Time Frame: Baseline and 6 months
Number of subjects with adverse events and serious adverse events as a measure of safety and tolerability
Time Frame: 6 months
Change in blood pressure
Time Frame: Baseline and 6 months
Change in red blood cell count
Time Frame: Baseline and 6 months
Secondary Outcomes
- Progression-free survival (PFS)(Baseline to progression or death by any reason)
- Maximum reduction from baseline in the target lesion size(Baseline and every 56 days up to progressive disease)
- 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)
- Overall survival (OS)(Baseline to 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)
- Response rate (RR)(Baseline and every 56 days up to progressive disease)
- Disease control rate (DCR)(Baseline and every 56 days up to progressive disease)
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