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

Thyroid Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02114658
• Other study ID #: 17073
• Status: Completed
• Phase: Phase 2
• First received: April 8, 2014
• Last updated: August 1, 2017
• Start date: April 15, 2014
• Est. completion date: August 2, 2016

Study information

• Verified date: August 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 2, 2016
• Est. primary completion date: February 23, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Neuroendocrine
• Thyroid Carcinoma
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• Sorafenib (Nexavar,BAY43-9006)
Sorafenib 400 mg will be administered orally,twice daily in a 28 day cycle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with adverse events and serious adverse events as a measure of safety and tolerability		6 months
Primary	Change in red blood cell count		Baseline and 6 months
Primary	Change in white blood cell count		Baseline and 6 months
Primary	Change in alanine aminotransaminase level (ALT)		Baseline and 6 months
Primary	Change in aspartate aminotransferase level (AST)		Baseline and 6 months
Primary	Change in blood pressure		Baseline and 6 months
Secondary	Best overall response based on RECIST 1.1 criteria		Baseline and every 56 days up to progressive disease,an expected average of 8 months
Secondary	Plasma concentration of sorafenib		Cycle 2 Day 1
Secondary	Progression-free survival (PFS)		Baseline to progression or death by any reason
Secondary	Overall survival (OS)		Baseline to death by any reason
Secondary	Response rate (RR)	RR based on RECIST 1.1 criteria	Baseline and every 56 days up to progressive disease
Secondary	Disease control rate (DCR)	DCR based on RECIST 1.1 criteria	Baseline and every 56 days up to progressive disease
Secondary	Maximum reduction from baseline in the target lesion size		Baseline and every 56 days up to progressive disease
Secondary	Maximum percentage change of calcitonin and Carcinoembryonic antigen (CEA) values from baseline	MTC subjects only	Baseline and every 56 days up to progressive disease

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