Clinical trial NCT02114658: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thyroid Carcinoma
Keywords: Anaplastic and medullary thyroid carcinoma
Thyroid Neoplasms
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2014-04-15
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Number of subjects with adverse events and serious adverse events as a measure of safety and tolerability
timeFrame: 6 months
measure: Change in red blood cell count
timeFrame: Baseline and 6 months
measure: Change in white blood cell count
timeFrame: Baseline and 6 months
measure: Change in alanine aminotransaminase level (ALT)
timeFrame: Baseline and 6 months
measure: Change in aspartate aminotransferase level (AST)
timeFrame: Baseline and 6 months
measure: Change in blood pressure
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Best overall response based on RECIST 1.1 criteria
timeFrame: Baseline and every 56 days up to progressive disease,an expected average of 8 months
measure: Plasma concentration of sorafenib
timeFrame: Cycle 2 Day 1
measure: Progression-free survival (PFS)
timeFrame: Baseline to progression or death by any reason
measure: Overall survival (OS)
timeFrame: Baseline to death by any reason
measure: Response rate (RR)
timeFrame: Baseline and every 56 days up to progressive disease
measure: Disease control rate (DCR)
timeFrame: Baseline and every 56 days up to progressive disease
measure: Maximum reduction from baseline in the target lesion size
timeFrame: Baseline and every 56 days up to progressive disease
measure: Maximum percentage change of calcitonin and Carcinoembryonic antigen (CEA) values from baseline
timeFrame: Baseline and every 56 days up to progressive disease
Other outcomes:
Locations:
city: Kobe
country: Japan
state: Hyogo
city: Matsumoto
country: Japan
state: Nagano
city: Bunkyo-ku
country: Japan
state: Tokyo
city: Koto-ku
country: Japan
state: Tokyo
city: Osaka
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: