Study Completed

Thyroid carcinoma

Bayer Identifier:

17073

ClinicalTrials.gov Identifier:

NCT02114658

EudraCT Number:

Not Available

EU CT Number:

Not Available

Sorafenib Phase II study for Japanese anaplastic or medullary thyroid carcinoma patients

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).

Key Participants Requirements

Sex

Both

Age

18 - N/A

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

April 2014 - August 2016

Phase

Phase 2

Could I Receive a placebo

Products

Nexavar (Sorafenib, BAY43-9006)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Bunkyo-ku, 113-8603, Japan
Completed		Koto-ku, 135-8550, Japan
Completed		Osaka, 545-8586, Japan
Completed		Matsumoto, 390-8621, Japan
Completed		Kobe, 650-0011, Japan

Primary Outcome

Number of subjects with adverse events and serious adverse events as a measure of safety and tolerability
Time Frame:
6 months
Safety Issue:
Yes
Change in red blood cell count
Time Frame:
Baseline and 6 months
Safety Issue:
Yes
Change in white blood cell count
Time Frame:
Baseline and 6 months
Safety Issue:
Yes
Change in alanine aminotransaminase level (ALT)
Time Frame:
Baseline and 6 months
Safety Issue:
Yes
Change in aspartate aminotransferase level (AST)
Time Frame:
Baseline and 6 months
Safety Issue:
Yes
Change in blood pressure
Time Frame:
Baseline and 6 months
Safety Issue:
Yes

Secondary Outcome

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
Safety Issue:
No
Plasma concentration of sorafenib
Time Frame:
Cycle 2 Day 1
Safety Issue:
No
Progression-free survival (PFS)
Time Frame:
Baseline to progression or death by any reason
Overall survival (OS)
Time Frame:
Baseline to death by any reason
Response rate (RR)
RR based on RECIST 1.1 criteria
Time Frame:
Baseline and every 56 days up to progressive disease
Disease control rate (DCR)
DCR based on RECIST 1.1 criteria
Time Frame:
Baseline and every 56 days up to progressive disease
Maximum reduction from baseline in the target lesion size
Time Frame:
Baseline and every 56 days up to progressive disease
Maximum percentage change of calcitonin and Carcinoembryonic antigen (CEA) values from baseline
MTC subjects only
Time Frame:
Baseline and every 56 days up to progressive disease

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

Additional Information

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