Thyroid CancerPhase 4NCT01496313
To Compare The Effects Of Two Doses Of Vandetanib In Patients With Advanced Medullary Thyroid Cancer
A Phase 4 study testing 300mg vandetanib and 150mg vandetanib in people with Thyroid Cancer, run by Sanofi at 30 sites in 9 countries.
Trial summary
The purpose of this study is to give patients with medullary thyroid cancer either 300mg/day or 150mg/day vandetanib and compare how well each dose affects how their cancer responds. It will also help the investigators understand the side effects of different doses in these patients. 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?
- 300mg vandetanib and 150mg vandetanib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 30 sitesin 9 countries
- Study dates
- 8 Jun 2012to 11 Jul 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Written consent from Female or male patients aged 18 years and over. Previously confirmed histological diagnosis of unresectable, locally advanced or metastatic, hereditary or sporadic MTC Objective disease progression within the previous 14 months prior to enrolment, and/or
- Have one or more symptoms that the Investigator believes to be related to the patient's MTC.
- World Health Organisation (WHO) or Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
- Has measurable disease (at least one lesion, not irradiated within 12 weeks of study randomisation, with longest diameter more or equal 10mm (lymph nodes minimum more or equal 15 mm) with CT or MRI).
- Lesions must be amenable to accurate and repeat measurement.
Who cannot join
- Prior treatment (major surgery, radiation therapy, chemotherapy, or other investigational drugs) received within 28 days before randomization.
- Abnormal liver function tests (bilirubin more than 1.5xULRR, and ALT, AST, or ALP more than 2.5xULRR or 5.0xULRR if related to liver metastases).
- Significant cardiac conditions or events such as reduced cardiac functions, symptomatic cardiac arrhythmia requiring treatment, congenital long QT syndrome, history of drug-induced QT prolongation, or QTcF correction unmeasurable or more than 450 ms.
- Abnormal electrolytes such as potassium, magnesium and calcium, or abnormal organ functions such as decreased creatinine clearance.
- For women only - currently pregnant or breast feeding.
Trial locations and contacts
30 sites in 9 countries.
30 sites in 9 countries
Italy7 sites
Research Site
Catania
Research Site
Milan
Research Site
Palermo
Research Site
Pisa
Research Site
Roma
Research Site
Siena
Research Site
Torino
Poland5 sites
Investigational Site Number : 5703
Gliwice, 44-101
Research Site
Gliwice
Investigational Site Number : 5704
Warsaw, Masovian Voivodeship, 02-781
Research Site
Warsaw
Research Site
Zgierz
Czechia4 sites
Investigational Site Number : 1903
Olomouc, 77900
Research Site
Olomouc
Investigational Site Number : 1901
Prague, 15006
Research Site
Prague
Israel4 sites
Research Site
Beersheba
Research Site
Haifa
Research Site
Jerusalem
Research Site
Petah Tikva
United Kingdom4 sites
Research Site
Cardiff
Research Site
Greater London
Research Site
London
Research Site
Tyne & Wear
About this study
Official title: An International, Randomised, Double-Blind, Two-Arm Study To Evaluate The Safety And Efficacy Of Vandetanib 150 And 300mg/Day In Patients With Unresectable Locally Advanced Or Metastatic Medullary Thyroid Carcinoma With Progressive Or Symptomatic Disease
The purpose of this study is to give patients with medullary thyroid cancer either 300mg/day or 150mg/day vandetanib and compare how well each dose affects how their cancer responds. It will also help the investigators understand the side effects of different doses in these patients.
Read the detailed description
An International, Randomised, Double-Blind, Two-Arm Study To Evaluate The Safety And Efficacy Of Vandetanib 150 And 300mg/Day In Patients With Unresectable Locally Advanced Or Metastatic Medullary Thyroid Carcinoma With Progressive Or Symptomatic Disease
- Conditions
- Thyroid Cancer
- Being tested
- 300mg vandetanib, 150mg vandetanib
- Keywords
- medullary thyroid cancer, metastatic, thyroid cancer, carcinoma of the thyroid, receptor tyrosine kinase inhibitor, VEGFR, Unresectable locally advanced thyroid cancer
- Medical subject headings
- Thyroid Neoplasms, Carcinoma, Medullary, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
300mg vandetanibDrug
Also called SAR390530
Oral blinded tablets taken once daily.
At objective disease progression or 14 months (whichever is earlier), patient may be unblinded to treatment
Dosing with unblinded study treatment can continue until 24 months after patient was randomised.
At any time dosing may be interrupted for up to 6 weeks due to toxicity. Dosing may restart at a reduced dose (200mg/day). Once reduced, dose increases are not permitted and dosing must stop if further toxicities occur.
150mg vandetanibDrug
Also called SAR390530
Oral blinded tablets taken once daily.
At objective disease progression or 14 months (whichever is earlier), patient may be unblinded to treatment. Patients who have not dose reduced at the time of unblinding may have their dose increased to 300mg
Dosing with unblinded study treatment can continue until 24 months after patient was randomised
At any time dosing may be interrupted for up to 6 weeks due to toxicity. Dosing may restart at a reduced dose (100mg/day) [OR 300 reduced to 200mg/day if dose was increased at unblinding.] Once reduced, dose increases are not permitted and dosing must stop if further toxicities occur.
| Study group | Role | What they receive |
|---|---|---|
| 300mg vandetanib | Active comparator | Not described Receives: Drug: 300mg vandetanib |
| 150mg vandetanib | Active comparator | Not described Receives: Drug: 150mg vandetanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR) for Vandetanib 150 and 300mg With Responses Determined by the Investigator
ORR=proportion of patients with a best response of complete or partial response as per Response Evaluation Criteria in Solid Tumors(RECIST)1.1
Measured: Randomisation to week 60 (maximum)
Secondary outcomes (5)
Best Objective Response
Measured: Randomisation to week 60 (maximum)
Duration of Objective Response (RECIST 1.1) by Treatment Arm
Measured: Randomization to Week 60 (maximum)
Time to Objective Response (RECIST 1.1) by Treatment Arm
Measured: Randomization to Week 60 (maximum)
Percentage Change From Baseline in Target Lesion Size (RECIST 1.1) by Treatment Arm
Measured: Randomization to Week 60 (maximum)
Plasma Concentration of Vandetanib in the Bloodstream (Cmax) for Patients by Treatment Arm.
Measured: Week 3 to week 60 (maximum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study start8 Jun 2012
- Primary completion2 Apr 2014
- Study completion11 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by SanofiThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study chair, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496313
- Sponsor's protocol ID
- D4200C00097
- Other IDs
- LPS14809, 2011-004701-24
- Status last verified
- Sep 2025
- First submitted
- 2 Dec 2011
- Last updated
- 3 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International, Randomised, Double-Blind, Two-Arm Study To Evaluate The Safety And Efficacy Of Vandetanib 150 And 300mg/Day In Patients With Unresectable Locally Advanced Or Metastatic Medullary Thyroid Carcinoma With Progressive Or Symptomatic Disease
- ClinicalTrials.gov ID
- NCT01496313
- Acronym / sponsor ID
- D4200C00097
- Conditions
- Thyroid Cancer
- Keywords
- medullary thyroid cancer, metastatic, thyroid cancer, carcinoma of the thyroid, receptor tyrosine kinase inhibitor, VEGFR, Unresectable locally advanced thyroid cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 8 Jun 2012 (actual)
- Primary completion
- 2 Apr 2014 (actual)
- Study completion
- 11 Jul 2024 (actual)
- First posted
- 21 Dec 2011 (estimated)
- Results
- Posted 27 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to give patients with medullary thyroid cancer either 300mg/day or 150mg/day vandetanib and compare how well each dose affects how their cancer responds. It will also help the investigators understand the side effects of different doses in these patients.
Detailed description
An International, Randomised, Double-Blind, Two-Arm Study To Evaluate The Safety And Efficacy Of Vandetanib 150 And 300mg/Day In Patients With Unresectable Locally Advanced Or Metastatic Medullary Thyroid Carcinoma With Progressive Or Symptomatic Disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 300mg vandetanib | Active comparator | Drug: 300mg vandetanib |
| 150mg vandetanib | Active comparator | Drug: 150mg vandetanib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written consent from Female or male patients aged 18 years and over. Previously confirmed histological diagnosis of unresectable, locally advanced or metastatic, hereditary or sporadic MTC Objective disease progression within the previous 14 months prior to enrolment, and/or
- Have one or more symptoms that the Investigator believes to be related to the patient's MTC.
- World Health Organisation (WHO) or Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
- Has measurable disease (at least one lesion, not irradiated within 12 weeks of study randomisation, with longest diameter more or equal 10mm (lymph nodes minimum more or equal 15 mm) with CT or MRI).
- Lesions must be amenable to accurate and repeat measurement.
Key exclusion criteria (5 listed)
- Prior treatment (major surgery, radiation therapy, chemotherapy, or other investigational drugs) received within 28 days before randomization.
- Abnormal liver function tests (bilirubin more than 1.5xULRR, and ALT, AST, or ALP more than 2.5xULRR or 5.0xULRR if related to liver metastases).
- Significant cardiac conditions or events such as reduced cardiac functions, symptomatic cardiac arrhythmia requiring treatment, congenital long QT syndrome, history of drug-induced QT prolongation, or QTcF correction unmeasurable or more than 450 ms.
- Abnormal electrolytes such as potassium, magnesium and calcium, or abnormal organ functions such as decreased creatinine clearance.
- For women only - currently pregnant or breast feeding.
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 |
|---|---|---|
| 300mg vandetanibAlso: SAR390530Oral blinded tablets taken once daily. At objective disease progression or 14 months (whichever is earlier), patient may be unblinded to treatment Dosing with unblinded study treatment can continue until 24 months after patient was randomised. At any time dosing may be interrupted for up to 6 weeks due to toxicity. Dosing may restart at a reduced dose (200mg/day). Once reduced, dose increases are not permitted and dosing must stop if further toxicities occur. | Drug | 300mg vandetanib |
| 150mg vandetanibAlso: SAR390530Oral blinded tablets taken once daily. At objective disease progression or 14 months (whichever is earlier), patient may be unblinded to treatment. Patients who have not dose reduced at the time of unblinding may have their dose increased to 300mg Dosing with unblinded study treatment can continue until 24 months after patient was randomised At any time dosing may be interrupted for up to 6 weeks due to toxicity. Dosing may restart at a reduced dose (100mg/day) [OR 300 reduced to 200mg/day if dose was increased at unblinding.] Once reduced, dose increases are not permitted and dosing must stop if further toxicities occur. | Drug | 150mg vandetanib |
Primary outcome
Overall Response Rate (ORR) for Vandetanib 150 and 300mg With Responses Determined by the Investigator
Time frame: Randomisation to week 60 (maximum)
ORR=proportion of patients with a best response of complete or partial response as per Response Evaluation Criteria in Solid Tumors(RECIST)1.1
5 secondary outcomes
Best Objective Response
Time frame: Randomisation to week 60 (maximum)
Duration of Objective Response (RECIST 1.1) by Treatment Arm
Time frame: Randomization to Week 60 (maximum)
Time to Objective Response (RECIST 1.1) by Treatment Arm
Time frame: Randomization to Week 60 (maximum)
Percentage Change From Baseline in Target Lesion Size (RECIST 1.1) by Treatment Arm
Time frame: Randomization to Week 60 (maximum)
Plasma Concentration of Vandetanib in the Bloodstream (Cmax) for Patients by Treatment Arm.
Time frame: Week 3 to week 60 (maximum)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- D4200C00097\_CSR\_Synopsis.pdfLink provided by the sponsor.
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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.
Clinical Sciences & Operations study chair
Sanofi
30 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 300mg vandetanib and 150mg vandetanib in people with Thyroid Cancer, run by Sanofi at 30 sites in 9 countries.
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 5 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 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Italy, Poland, Czechia, Israel, United Kingdom and 4 more countries. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Response Rate (ORR) for Vandetanib 150 and 300mg With Responses Determined by the Investigator (time frame: Randomisation to week 60 (maximum)). 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 Oct 2025.