Trial Condition(s):
Thyroid carcinoma
Sorafenib Phase II study for Japanese anaplastic or medullary thyroid carcinoma patients
Bayer Identifier:
17073
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial 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).
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Bunkyo-ku, Japan, 113-8603 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Koto-ku, Japan, 135-8550 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osaka, Japan, 545-8586 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Matsumoto, Japan, 390-8621 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kobe, Japan, 650-0011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Number of subjects with adverse events and serious adverse events as a measure of safety and tolerabilityTimeframe: 6 months
- Change in red blood cell countTimeframe: Baseline and 6 months
- Change in white blood cell countTimeframe: Baseline and 6 months
- Change in alanine aminotransaminase level (ALT)Timeframe: Baseline and 6 months
- Change in aspartate aminotransferase level (AST)Timeframe: Baseline and 6 months
- Change in blood pressureTimeframe: Baseline and 6 months
Secondary Outcome
- Best overall response based on RECIST 1.1 criteriaTimeframe: Baseline and every 56 days up to progressive disease,an expected average of 8 months
- Plasma concentration of sorafenibTimeframe: Cycle 2 Day 1
- Progression-free survival (PFS)Timeframe: Baseline to progression or death by any reason
- Overall survival (OS)Timeframe: Baseline to death by any reason
- Response rate (RR)RR based on RECIST 1.1 criteriaTimeframe: Baseline and every 56 days up to progressive disease
- Disease control rate (DCR)DCR based on RECIST 1.1 criteriaTimeframe: Baseline and every 56 days up to progressive disease
- Maximum reduction from baseline in the target lesion sizeTimeframe: Baseline and every 56 days up to progressive disease
- Maximum percentage change of calcitonin and Carcinoembryonic antigen (CEA) values from baselineMTC subjects onlyTimeframe: Baseline and every 56 days up to progressive disease
Additional Information
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