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

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: April 8, 2014
Last updated: August 1, 2017
Last verified: August 2017
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).

Condition Intervention Phase
Thyroid Carcinoma Drug: Sorafenib (Nexavar,BAY43-9006) Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Number of subjects with adverse events and serious adverse events as a measure of safety and tolerability [ Time Frame: 6 months ]
  • Change in red blood cell count [ Time Frame: Baseline and 6 months ]
  • 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 ]
  • Change in blood pressure [ Time Frame: Baseline and 6 months ]

Secondary Outcome Measures:
  • Best overall response based on RECIST 1.1 criteria [ Time Frame: Baseline and every 56 days up to progressive disease,an expected average of 8 months ]
  • Plasma concentration of sorafenib [ Time Frame: Cycle 2 Day 1 ]
  • Progression-free survival (PFS) [ Time Frame: Baseline to progression or death by any reason ]
  • Overall survival (OS) [ Time Frame: Baseline to death by any reason ]
  • Response rate (RR) [ Time Frame: Baseline and every 56 days up to progressive disease ]
    RR based on RECIST 1.1 criteria

  • Disease control rate (DCR) [ Time Frame: Baseline and every 56 days up to progressive disease ]
    DCR based on RECIST 1.1 criteria

  • Maximum reduction from baseline in the target lesion size [ Time Frame: Baseline and every 56 days up to progressive disease ]
  • Maximum percentage change of calcitonin and Carcinoembryonic antigen (CEA) values from baseline [ Time Frame: Baseline and every 56 days up to progressive disease ]
    MTC subjects only

Enrollment: 18
Actual Study Start Date: April 15, 2014
Study Completion Date: August 2, 2016
Primary Completion Date: February 23, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02114658

Kobe, Hyogo, Japan, 650-0011
Matsumoto, Nagano, Japan, 390-8621
Bunkyo-ku, Tokyo, Japan, 113-8603
Koto-ku, Tokyo, Japan, 135-8550
Osaka, Japan, 545-8586
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT02114658     History of Changes
Other Study ID Numbers: 17073
Study First Received: April 8, 2014
Last Updated: August 1, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
Anaplastic and medullary thyroid carcinoma
Thyroid Neoplasms

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Carcinoma, Neuroendocrine
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs processed this record on September 21, 2017