Back to resultsSorafenib Phase II Study for Japanese Anaplastic or Medullary Thyroid Carcinoma Patients
Primary Purpose
Thyroid Carcinoma
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Sorafenib (Nexavar,BAY43-9006)
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Carcinoma focused on measuring Anaplastic and medullary thyroid carcinoma, Thyroid Neoplasms
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
Sorafenib 400 mg bid continuous dose
Outcomes
Primary Outcome Measures
Number of subjects with adverse events and serious adverse events as a measure of safety and tolerability
Change in red blood cell count
Change in white blood cell count
Change in alanine aminotransaminase level (ALT)
Change in aspartate aminotransferase level (AST)
Change in blood pressure
Secondary Outcome Measures
Best overall response based on RECIST 1.1 criteria
Plasma concentration of sorafenib
Progression-free survival (PFS)
Overall survival (OS)
Response rate (RR)
RR based on RECIST 1.1 criteria
Disease control rate (DCR)
DCR based on RECIST 1.1 criteria
Maximum reduction from baseline in the target lesion size
Maximum percentage change of calcitonin and Carcinoembryonic antigen (CEA) values from baseline
MTC subjects only
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02114658
Brief Title
Sorafenib Phase II Study for Japanese Anaplastic or Medullary Thyroid Carcinoma Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 15, 2014 (Actual)
Primary Completion Date
February 23, 2015 (Actual)
Study Completion Date
August 2, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Carcinoma
Keywords
Anaplastic and medullary thyroid carcinoma, Thyroid Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Sorafenib 400 mg bid continuous dose
Intervention Type
Drug
Intervention Name(s)
Sorafenib (Nexavar,BAY43-9006)
Intervention Description
Sorafenib 400 mg will be administered orally,twice daily in a 28 day cycle
Primary Outcome Measure Information:
Title
Number of subjects with adverse events and serious adverse events as a measure of safety and tolerability
Time Frame
6 months
Title
Change in red blood cell count
Time Frame
Baseline and 6 months
Title
Change in white blood cell count
Time Frame
Baseline and 6 months
Title
Change in alanine aminotransaminase level (ALT)
Time Frame
Baseline and 6 months
Title
Change in aspartate aminotransferase level (AST)
Time Frame
Baseline and 6 months
Title
Change in blood pressure
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
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
Title
Plasma concentration of sorafenib
Time Frame
Cycle 2 Day 1
Title
Progression-free survival (PFS)
Time Frame
Baseline to progression or death by any reason
Title
Overall survival (OS)
Time Frame
Baseline to death by any reason
Title
Response rate (RR)
Description
RR based on RECIST 1.1 criteria
Time Frame
Baseline and every 56 days up to progressive disease
Title
Disease control rate (DCR)
Description
DCR based on RECIST 1.1 criteria
Time Frame
Baseline and every 56 days up to progressive disease
Title
Maximum reduction from baseline in the target lesion size
Time Frame
Baseline and every 56 days up to progressive disease
Title
Maximum percentage change of calcitonin and Carcinoembryonic antigen (CEA) values from baseline
Description
MTC subjects only
Time Frame
Baseline and every 56 days up to progressive disease
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0011
Country
Japan
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
390-8621
Country
Japan
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
12. IPD Sharing Statement
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Sorafenib Phase II Study for Japanese Anaplastic or Medullary Thyroid Carcinoma Patients
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