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Completed

NCT Number: NCT02114658

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

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).

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Key information

Conditions

Thyroid Carcinoma Adenocarcinoma Carcinoma Carcinoma, Medullary Carcinoma, Neuroendocrine Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Thyroid Diseases Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kobe, Hyōgo, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sorafenib (Nexavar,BAY43-9006)

Drug

Sorafenib 400 mg will be administered orally,twice daily in a 28 day cycle

Primary outcomes

  1. Number of subjects with adverse events and serious adverse events as a measure of safety and tolerability

    Time frame: 6 months

  2. Change in red blood cell count

    Time frame: Baseline and 6 months

  3. Change in white blood cell count

    Time frame: Baseline and 6 months

  4. Change in alanine aminotransaminase level (ALT)

    Time frame: Baseline and 6 months

  5. Change in aspartate aminotransferase level (AST)

    Time frame: Baseline and 6 months

  6. Change in blood pressure

    Time frame: Baseline and 6 months

Secondary outcomes

  1. 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

  2. Plasma concentration of sorafenib

    Time frame: Cycle 2 Day 1

  3. Progression-free survival (PFS)

    Time frame: Baseline to progression or death by any reason

  4. Overall survival (OS)

    Time frame: Baseline to death by any reason

  5. Response rate (RR)

    Time frame: Baseline and every 56 days up to progressive disease

    RR based on RECIST 1.1 criteria

  6. Disease control rate (DCR)

    Time frame: Baseline and every 56 days up to progressive disease

    DCR based on RECIST 1.1 criteria

  7. Maximum reduction from baseline in the target lesion size

    Time frame: Baseline and every 56 days up to progressive disease

  8. 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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Apr 15, 2014
Registry last updated
Aug 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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