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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT02114658

Collaborator

(none)

Enrollment

Locations

Arm

27.6

Actual Duration (Months)

3.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Thyroid Carcinoma	Drug: Sorafenib (Nexavar,BAY43-9006)	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Actual Study Start Date :

Apr 15, 2014

Actual Primary Completion Date :

Feb 23, 2015

Actual Study Completion Date :

Aug 2, 2016

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Best overall response based on RECIST 1.1 criteria [Baseline and every 56 days up to progressive disease,an expected average of 8 months]
Plasma concentration of sorafenib [Cycle 2 Day 1]
Progression-free survival (PFS) [Baseline to progression or death by any reason]
Overall survival (OS) [Baseline to death by any reason]
Response rate (RR) [Baseline and every 56 days up to progressive disease]
RR based on RECIST 1.1 criteria
Disease control rate (DCR) [Baseline and every 56 days up to progressive disease]
DCR based on RECIST 1.1 criteria
Maximum reduction from baseline in the target lesion size [Baseline and every 56 days up to progressive disease]
Maximum percentage change of calcitonin and Carcinoembryonic antigen (CEA) values from baseline [Baseline and every 56 days up to progressive disease]
MTC subjects only

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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