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

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).

Study Overview

• Status: Completed
• Conditions: Thyroid Carcinoma
• Intervention / Treatment: Drug: Sorafenib (Nexavar,BAY43-9006)

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan, 545-8586
  • Hyogo
    • Kobe, Hyogo, Japan, 650-0011
  • Nagano
    • Matsumoto, Nagano, Japan, 390-8621
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8603
    • Koto-ku, Tokyo, Japan, 135-8550

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Sorafenib 400 mg bid continuous dose	Drug: Sorafenib (Nexavar,BAY43-9006); Sorafenib 400 mg will be administered orally,twice daily in a 28 day cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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
Change in blood pressure	Baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Progression-free survival (PFS)		Baseline to progression or death by any reason
Overall survival (OS)		Baseline to death by any reason
Response rate (RR)	RR based on RECIST 1.1 criteria	Baseline and every 56 days up to progressive disease
Disease control rate (DCR)	DCR based on RECIST 1.1 criteria	Baseline and every 56 days up to progressive disease
Maximum reduction from baseline in the target lesion size		Baseline and every 56 days up to progressive disease
Maximum percentage change of calcitonin and Carcinoembryonic antigen (CEA) values from baseline	MTC subjects only	Baseline and every 56 days up to progressive disease

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2014
• Primary Completion (Actual): February 23, 2015
• Study Completion (Actual): August 2, 2016

Study Registration Dates

• First Submitted: April 8, 2014
• First Submitted That Met QC Criteria: April 14, 2014
• First Posted (Estimate): April 15, 2014

Study Record Updates

• Last Update Posted (Actual): August 3, 2017
• Last Update Submitted That Met QC Criteria: August 1, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Thyroid Neoplasms; Anaplastic and medullary thyroid carcinoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Carcinoma; Thyroid Diseases; Thyroid Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Sorafenib
• Other Study ID Numbers: 17073

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No