Thyroid CarcinomaPhase 2NCT02114658
Sorafenib Phase II Study for Japanese Anaplastic or Medullary Thyroid Carcinoma Patients
A Phase 2 study testing Sorafenib (Nexavar,BAY43-9006) in people with Thyroid Carcinoma, run by Bayer at 5 sites in Japan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Carcinoma
- What is being tested?
- Sorafenib (Nexavar,BAY43-9006)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 5 sitesJapan
- Study dates
- 15 Apr 2014to 2 Aug 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
Japan5 sites
Study site
Bunkyo-ku, Tokyo, 113-8603
Study site
Kobe, Hyōgo, 650-0011
Study site
Koto-ku, Tokyo, 135-8550
Study site
Matsumoto, Nagano, 390-8621
Study site
Osaka, 545-8586
About this study
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
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).
- Conditions
- Thyroid Carcinoma
- Being tested
- Sorafenib (Nexavar,BAY43-9006)
- Keywords
- Anaplastic and medullary thyroid carcinoma, Thyroid Neoplasms
- Medical subject headings
- Thyroid Neoplasms, Carcinoma, Medullary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sorafenib (Nexavar,BAY43-9006)Drug
Sorafenib 400 mg will be administered orally,twice daily in a 28 day cycle
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Sorafenib 400 mg bid continuous dose Receives: Drug: Sorafenib (Nexavar,BAY43-9006) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events and serious adverse events as a measure of safety and tolerability
Measured: 6 months
Change in red blood cell count
Measured: Baseline and 6 months
Change in white blood cell count
Measured: Baseline and 6 months
Change in alanine aminotransaminase level (ALT)
Measured: Baseline and 6 months
Change in aspartate aminotransferase level (AST)
Measured: Baseline and 6 months
Change in blood pressure
Measured: Baseline and 6 months
Secondary outcomes (8)
Best overall response based on RECIST 1.1 criteria
Measured: Baseline and every 56 days up to progressive disease,an expected average of 8 months
Plasma concentration of sorafenib
Measured: Cycle 2 Day 1
Progression-free survival (PFS)
Measured: Baseline to progression or death by any reason
Overall survival (OS)
Measured: Baseline to death by any reason
Response rate (RR)
RR based on RECIST 1.1 criteria
Measured: Baseline and every 56 days up to progressive disease
Disease control rate (DCR)
DCR based on RECIST 1.1 criteria
Measured: Baseline and every 56 days up to progressive disease
Maximum reduction from baseline in the target lesion size
Measured: Baseline and every 56 days up to progressive disease
Maximum percentage change of calcitonin and Carcinoembryonic antigen (CEA) values from baseline
MTC subjects only
Measured: Baseline and every 56 days up to progressive disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study start15 Apr 2014
- Primary completion23 Feb 2015
- Study completion2 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CarcinomaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114658
- Sponsor's protocol ID
- 17073
- Status last verified
- Aug 2017
- First submitted
- 8 Apr 2014
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02114658
- Acronym / sponsor ID
- 17073
- Conditions
- Thyroid Carcinoma
- Keywords
- Anaplastic and medullary thyroid carcinoma, Thyroid Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2014 (actual)
- Primary completion
- 23 Feb 2015 (actual)
- Study completion
- 2 Aug 2016 (actual)
- First posted
- 15 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Sorafenib (Nexavar,BAY43-9006)Sorafenib 400 mg bid continuous dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sorafenib (Nexavar,BAY43-9006)Sorafenib 400 mg will be administered orally,twice daily in a 28 day cycle | Drug | Arm 1 |
Primary outcome
Number of subjects with adverse events and serious adverse events as a measure of safety and tolerability
Time frame: 6 months
Change in red blood cell count
Time frame: Baseline and 6 months
Change in white blood cell count
Time frame: Baseline and 6 months
Change in alanine aminotransaminase level (ALT)
Time frame: Baseline and 6 months
Change in aspartate aminotransferase level (AST)
Time frame: Baseline and 6 months
Change in blood pressure
Time frame: Baseline and 6 months
8 secondary outcomes
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
Plasma concentration of sorafenib
Time frame: Cycle 2 Day 1
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)
Time frame: Baseline and every 56 days up to progressive disease
Disease control rate (DCR)
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
Time frame: Baseline and every 56 days up to progressive disease
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sorafenib (Nexavar,BAY43-9006) in people with Thyroid Carcinoma, run by Bayer at 5 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with adverse events and serious adverse events as a measure of safety and tolerability (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2017; AzTrials last refreshed its copy on 6 Nov 2026.