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

Phase 2

Completed

• Conditions: Thyroid Carcinoma
• Interventions: Drug: Sorafenib (Nexavar,BAY43-9006)

• Registration Number: NCT02114658
• Lead Sponsor: Bayer

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-08
• Study First Submitted QC: 2014-04-14
• Study Start: 2014-04-15
• Study First Posted: 2014-04-15
• Primary Completion: 2015-02-23
• Study Completion: 2016-08-02
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-01
• Last Update Posted: 2017-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Sorafenib (Nexavar,BAY43-9006)	Sorafenib 400 mg bid continuous dose

Primary Outcome Measures

Name	Time	Method
Change in red blood cell count	Baseline and 6 months
Change in white blood cell count	Baseline and 6 months
Change in alanine aminotransaminase level (ALT)	Baseline and 6 months
Change in aspartate aminotransferase level (AST)	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 blood pressure	Baseline and 6 months

Secondary Outcome Measures

Name	Time	Method
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
Plasma concentration of sorafenib	Cycle 2 Day 1
Best overall response based on RECIST 1.1 criteria	Baseline and every 56 days up to progressive disease,an expected average of 8 months
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	MTC subjects only
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