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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT02114658
First received: April 8, 2014
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
  • Change in red blood cell count [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: Yes ]
  • Change in white blood cell count [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: Yes ]
  • Change in alanine aminotransaminase level (ALT) [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: Yes ]
  • Change in aspartate aminotransferase level (AST) [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: Yes ]
  • Change in blood pressure [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tumor response based on RECIST 1.1 criteria [ Time Frame: Baseline and every 56 days up to progressive disease,an expected average of 8 months ] [ Designated as safety issue: No ]
  • Plasma concentration of sorafenib [ Time Frame: Cycle 2 Day 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: April 2014
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT02114658

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02114658     History of Changes
Other Study ID Numbers: 17073
Study First Received: April 8, 2014
Last Updated: August 28, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

Additional relevant MeSH terms:
Thyroid Neoplasms
Carcinoma
Thyroid Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014