Thyroid CancerPhase 2NCT02084732
Safety and Efficacy of Sorafenib in Patients With Advanced Thyroid Cancer: a Phase II Clinical Study
A Phase 2 study testing Sorafenib in people with Thyroid Cancer, run by Instituto Nacional de Cancerologia, Columbia at 1 site in Colombia.
Trial summary
Differentiated thyroid cancer includes papillary, follicular, Hurthle cell, and C-cell/medullary carcinoma. Even though incidence is relatively low (1% of all neoplasms), a rise in this disease has been recorded in the country (The Atlas of Cancer Mortality in Colombia, 2010). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Sorafenib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteColombia
- Study dates
- 1 Oct 2013to 1 Nov 2019
- 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
- Older than 18 years.
- Confirmed histological diagnosis of differentiated thyroid cancer, whether metastatic or unresectable, for whom conventional curative or palliative therapeutic options do not exist or are not effective. It includes patients with lesions visible in images, that have no uptake at therapeutic doses of iodine, or patients with iodine avid lesions, that keep progressing after therapeutic doses (greater than 100 mCi). Also comprises patients with persistent local disease progression not amenable to surgical management or radiation therapy management.
- The time that has passed since the last treatment until inclusion must of at least six (6) months.
- There must be at least 1 lesion that can be adequately measured according to the RECIST (v.1.1) criteria [See Appendix 1].
- Neck or lung lesions, surgery declared unresectable.
- Patients must have a ECOG score less than 2 and life expectancy greater than 3 months.
- Adequate bone marrow, liver and renal functions defined by the following laboratory parameters, taken no more than 7 days after consent signing: white blood cell count, > 3,000/uL; absolute neutrophil count, > 1,500/mm3; platelets, > 100,000/mm3; hemoglobin, 9 g/dl; serum creatinine, < 1.5 times the upper limit of normal (ULN) or creatinine clearance in urine for 24 hours > 75 cc/min; total serum bilirubin, < 1.5 times the ULN; glutamic oxaloacetic transaminase (SGOT), < 1.5 times the ULN; serium alkaline phosphatase, < 1.5 times the ULN; prothrombin time (PT-INR) and partial thromboplastin time (PTT), < 1.5 times the ULN.
- The patient must be physically, intellectually, and emotionally able to take the oral medicine.
- Patient must not be a candidate for surgery or radiotherapy with curative intent
- Women of childbearing potential should have a negative serum pregnancy test performed within 7 days prior to start of treatment. Post-menopausal women (at least one year with no menstruation) and surgically sterilized women do not require pregnancy tests.
- Women and also men of childbearing potential should agree to use adequate contraceptive methods
- Significant medical conditions including an uncontrolled hypertension (systolic blood blood pressure >150 mmHg or diastolic blood pressure > 90mmHg)
- Significant Hemorrhage or bleeding events, CTCAE grade 3 or higher, within 12 weeks of randomization. arterial or venous thrombotic or embolic events within the past 6 months (including cerebrovascular accidents and transient ischemic attacks, deep vein thrombosis, pulmonary embolism and arterial thrombosis).
- Recent major surgery or open biopsy procedure (within 4 weeks of study entry)
- Bone lesions will be excluded, by its susceptibility to radiotherapy and bisphosphonates management.
- Wounds, ulcers or bone fractures that are non healing
- Pregnancy or lactation.
- A personal history of a second neoplasm with the exception of squamous-cell or basal-cell skin cancer that is suitably treated, in situ cervical cancer, or any other previously treated cancer when one has stayed free of disease for 5 years or more.
- Prior use (4 weeks before admittance to the study) of chemotherapy or cancer immunotherapy.
- Prior use of of tyrosine kinase inhibitors or other targets agents, or monoclonal antibodies that target VEGF or VEGF receptors.
- Known or suspected allergy or hypersensitivity to sorafenib
- Having received radiotherapy in the 4 weeks preceding admittance to the study.
- Any condition according to the judgment of the treating physician that could jeopardize the patient's safety or compliance to the study.
- All patients that are admitted to the study must voluntarily consent to their participation and the same must be recorded in a written informed consent form.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Instituto Nacional de Cancerología
Bogotá, Cundinamarca, 00000
About this study
Differentiated thyroid cancer includes papillary, follicular, Hurthle cell, and C-cell/medullary carcinoma. Even though incidence is relatively low (1% of all neoplasms), a rise in this disease has been recorded in the country (The Atlas of Cancer Mortality in Colombia, 2010).
Although this disease has a low rate of attributable mortality, the costs arising from treatment, monitoring, and disabilities among affected patients and their families are high for the health system.
Read more
The therapeutic approach to differentiated thyroid cancer once it starts progressing is limited; there are no truly favorable treatment options for patients with advanced thyroid cancer: available options include surgery, radiotherapy, and radioactive iodine therapy.
Molecular biology now allows the identification of the effects of mutations and alterations in the proteins that participate in cell signaling which account for dedifferentiation, invasiveness, and the progression of neoplastic cells.
VEGFR (vascular endothelial growth factor receptor) is one of the main molecules to be addressed by targeted molecular therapy. Its increased expression in differentiated thyroid cancer has been demonstrated and has been associated with increased growth, invasiveness, and shorter recurrence-free survival.
Different agents are effective against this tyrosine kinase receptor; nevertheless, taking into account that it is not solely responsible for tumor progression, according to clinical study results, it is more reasonable to use non-selective tyrosine kinase inhibitors such as sorafenib and motesanib. These inhibitors have already been tested in phase II studies.
Results from recent phase II research studies using these emerging treatment options have shown important effects in the therapeutic approach to other solid neoplasms.
Information about the safety of this type of treatment is limited; a need for information regarding the use of new therapeutic approaches in Colombia is one of the contributions that the National Institute of Cancer can make to the country through this study.
Read the detailed description
Objective:
Determine the clinical efficacy and safety profile of sorafenib in the treatment of patients with advanced thyroid cancer (metastatic or recurrent) in a 24 months follow up period.
Analysis plan The analysis plan includes the description of clinical and epidemiological characteristics of recruited patients at the end of the first year and the before and after comparison from clinical response according to RECIST criteria. At the end of the first and second follow-up years, analyses will be performed. In each of these, the response of patients by outcomes of interest measured at specific monitoring times will be evaluated.
Parametric and non-parametric descriptive statistics will be used as necessary; the comparison of some variables between baseline measurements and follow-up predetermined cut-offs will be performed while taking into account the lack of independence between observations. Analysis of qualitative variables will be performed using McNemar's Test and the analysis of quantitative variables using the Paired Student's t-Test or Wilcoxon Test depending on the normality of the distribution
Descriptive statistics will be used for time until events, survival curve and progression-free time median will be stated. Correlation studies between some indicators, clinical variables, and observed outcomes using parametric and non-parametric coefficients will be performed. Interobserver agreement will be evaluated for the reading of diagnostic images using a Kappa coefficient.
- Conditions
- Thyroid Cancer
- Being tested
- Sorafenib
- Keywords
- Sorafenib, thyroid neoplasms, salicylic acid
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SorafenibDrug
Also called nexavar
drug
| Study group | Role | What they receive |
|---|---|---|
| Sorafenib | Experimental | drug Receives: Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the clinical activity and safety profile of sorafenib in the treatment of patients with advanced thyroid cancer (metastatic or recurrent) among a selected group of patients refractory to or ineligible to radioactive iodine (RAI) therapy
Measured: 3 years
Secondary outcomes (2)
Summarize the progression-free survival (PFS) of patients with advanced thyroid cancer (metastatic or recurrent) treated with sorafenib
Measured: two years
Describe the occurrence and type of adverse events associated with sorafenib use in advanced thyroid cancer (metastatic or recurrent) patients included
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study start1 Oct 2013
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancerologia, Columbia
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Luis F Fierro, Md, Principal investigator, Instituto Nacional de Cancerologia de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084732
- Sponsor's protocol ID
- 410-30610-258
- Status last verified
- Nov 2019
- First submitted
- 7 Mar 2014
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Sorafenib in Patients With Advanced Thyroid Cancer: a Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT02084732
- Acronym / sponsor ID
- 410-30610-258
- Conditions
- Thyroid Cancer
- Keywords
- Sorafenib, thyroid neoplasms, salicylic acid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Instituto Nacional de Cancerologia, ColumbiaOther government
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 12 Mar 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.
Differentiated thyroid cancer includes papillary, follicular, Hurthle cell, and C-cell/medullary carcinoma. Even though incidence is relatively low (1% of all neoplasms), a rise in this disease has been recorded in the country (The Atlas of Cancer Mortality in Colombia, 2010).
Although this disease has a low rate of attributable mortality, the costs arising from treatment, monitoring, and disabilities among affected patients and their families are high for the health system.
The therapeutic approach to differentiated thyroid cancer once it starts progressing is limited; there are no truly favorable treatment options for patients with advanced thyroid cancer: available options include surgery, radiotherapy, and radioactive iodine therapy.
Molecular biology now allows the identification of the effects of mutations and alterations in the proteins that participate in cell signaling which account for dedifferentiation, invasiveness, and the progression of neoplastic cells.
VEGFR (vascular endothelial growth factor receptor) is one of the main molecules to be addressed by targeted molecular therapy. Its increased expression in differentiated thyroid cancer has been demonstrated and has been associated with increased growth, invasiveness, and shorter recurrence-free survival.
Different agents are effective against this tyrosine kinase receptor; nevertheless, taking into account that it is not solely responsible for tumor progression, according to clinical study results, it is more reasonable to use non-selective tyrosine kinase inhibitors such as sorafenib and motesanib. These inhibitors have already been tested in phase II studies.
Results from recent phase II research studies using these emerging treatment options have shown important effects in the therapeutic approach to other solid neoplasms.
Information about the safety of this type of treatment is limited; a need for information regarding the use of new therapeutic approaches in Colombia is one of the contributions that the National Institute of Cancer can make to the country through this study.
Detailed description
Objective:
Determine the clinical efficacy and safety profile of sorafenib in the treatment of patients with advanced thyroid cancer (metastatic or recurrent) in a 24 months follow up period.
Analysis plan The analysis plan includes the description of clinical and epidemiological characteristics of recruited patients at the end of the first year and the before and after comparison from clinical response according to RECIST criteria. At the end of the first and second follow-up years, analyses will be performed. In each of these, the response of patients by outcomes of interest measured at specific monitoring times will be evaluated.
Parametric and non-parametric descriptive statistics will be used as necessary; the comparison of some variables between baseline measurements and follow-up predetermined cut-offs will be performed while taking into account the lack of independence between observations. Analysis of qualitative variables will be performed using McNemar's Test and the analysis of quantitative variables using the Paired Student's t-Test or Wilcoxon Test depending on the normality of the distribution
Descriptive statistics will be used for time until events, survival curve and progression-free time median will be stated. Correlation studies between some indicators, clinical variables, and observed outcomes using parametric and non-parametric coefficients will be performed. Interobserver agreement will be evaluated for the reading of diagnostic images using a Kappa coefficient.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sorafenib | Experimental | Drug: Sorafenibdrug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| SorafenibAlso: nexavardrug | Drug | Sorafenib |
Primary outcome
Describe the clinical activity and safety profile of sorafenib in the treatment of patients with advanced thyroid cancer (metastatic or recurrent) among a selected group of patients refractory to or ineligible to radioactive iodine (RAI) therapy
Time frame: 3 years
2 secondary outcomes
Summarize the progression-free survival (PFS) of patients with advanced thyroid cancer (metastatic or recurrent) treated with sorafenib
Time frame: two years
Describe the occurrence and type of adverse events associated with sorafenib use in advanced thyroid cancer (metastatic or recurrent) patients included
Time frame: two years
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 13 Nov 2019.
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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.
Luis F Fierro, Md principal investigator
Instituto Nacional de Cancerologia de Mexico
1 site 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 in people with Thyroid Cancer, run by Instituto Nacional de Cancerologia, Columbia at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. 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?
Describe the clinical activity and safety profile of sorafenib in the treatment of patients with advanced thyroid cancer (metastatic or recurrent) among a selected group of patients refractory to or ineligible to radioactive iodine (RAI) therapy (time frame: 3 years). 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 13 Nov 2019.