check_circleStudy 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
  • - 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

  • - 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
18
Trial Dates
April 2014 - August 2016
Phase
Phase 2
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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
    date_rangeTime Frame:
    6 months
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    Safety Issue:
    Yes
  • Change in red blood cell count
    date_rangeTime Frame:
    Baseline and 6 months
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    Safety Issue:
    Yes
  • Change in white blood cell count
    date_rangeTime Frame:
    Baseline and 6 months
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    Safety Issue:
    Yes
  • Change in alanine aminotransaminase level (ALT)
    date_rangeTime Frame:
    Baseline and 6 months
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    Safety Issue:
    Yes
  • Change in aspartate aminotransferase level (AST)
    date_rangeTime Frame:
    Baseline and 6 months
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    Safety Issue:
    Yes
  • Change in blood pressure
    date_rangeTime Frame:
    Baseline and 6 months
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    Safety Issue:
    Yes

Secondary Outcome

  • Best overall response based on RECIST 1.1 criteria
    date_rangeTime Frame:
    Baseline and every 56 days up to progressive disease,an expected average of 8 months
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    Safety Issue:
    No
  • Plasma concentration of sorafenib
    date_rangeTime Frame:
    Cycle 2 Day 1
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    Safety Issue:
    No
  • Progression-free survival (PFS)
    date_rangeTime Frame:
    Baseline to progression or death by any reason
  • Overall survival (OS)
    date_rangeTime Frame:
    Baseline to death by any reason
  • Response rate (RR)
    RR based on RECIST 1.1 criteria
    date_rangeTime Frame:
    Baseline and every 56 days up to progressive disease
  • Disease control rate (DCR)
    DCR based on RECIST 1.1 criteria
    date_rangeTime Frame:
    Baseline and every 56 days up to progressive disease
  • Maximum reduction from baseline in the target lesion size
    date_rangeTime 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
    date_rangeTime 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
1

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