NCT02114658

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 15, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

April 15, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2015

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2016

Completed
Last Updated

August 3, 2017

Status Verified

August 1, 2017

Enrollment Period

10 months

First QC Date

April 8, 2014

Last Update Submit

August 1, 2017

Conditions

Thyroid Carcinoma

Keywords

Anaplastic and medullary thyroid carcinomaThyroid Neoplasms

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (1)

Arm 1

EXPERIMENTAL

Sorafenib 400 mg bid continuous dose

Drug: Sorafenib (Nexavar,BAY43-9006)

Interventions

Sorafenib (Nexavar,BAY43-9006)DRUG

Sorafenib 400 mg will be administered orally,twice daily in a 28 day cycle

Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Kobe, Hyōgo, 650-0011, Japan

Location

Unknown Facility

Matsumoto, Nagano, 390-8621, Japan

Location

Unknown Facility

Bunkyo-ku, Tokyo, 113-8603, Japan

Location

Unknown Facility

Koto-ku, Tokyo, 135-8550, Japan

Location

Unknown Facility

Osaka, 545-8586, Japan

Location

MeSH Terms

Conditions

Thyroid NeoplasmsCarcinoma, Medullary

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesCarcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Ductal, Lobular, and MedullaryNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2014

First Posted

April 15, 2014

Study Start

April 15, 2014

Primary Completion

February 23, 2015

Study Completion

August 2, 2016

Last Updated

August 3, 2017

Record last verified: 2017-08

Locations

JP(5)