Locally Advanced or Metastatic Medullary Thyroid CancerPhase 3NCT01298323

Study to Determine if Contacting Patients With MTC More Frequently Results in Earlier Detection and Treatment of Signs and Symptoms of AEs and Thus a Decrease in the Percentage of Time Patients Experience AEs During First 12 Months on Vandetanib Treatment

A Phase 3 study testing Patient outreach and Vandetanib in people with Locally Advanced or Metastatic Medullary Thyroid Cancer and Medullary Thyroid Cancer, run by Sanofi at 66 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the effect of patient outreach program on the proportion of time patients with MTC experience moderate or severe AEs during first 12 months of treatment with vandetanib Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Locally Advanced or Metastatic Medullary Thyroid Cancer, Medullary Thyroid Cancer
What is being tested?: Patient outreach and Vandetanib
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 205 participants
Where: 66 sitesin 20 countries
Study dates: 25 Feb 2011to 13 Mar 2025
Phase: Phase 3
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

Provision of informed consent prior to any study specific procedures
Female or male aged 18 years and over
Previously confirmed histological diagnosis of unresectable, locally advanced or metastatic hereditary or sporadic MTC. Documentation must be provided in patient's medical chart
WHO or ECOG Performance status 0-2
Negative pregnancy test (urine or serum) for female patients of childbearing potential

Who cannot join

Unstable brain metastases or spinal cord compression that require treatment, unless treated at least 4 weeks before first dose and stable without steroid treatment for 10 days
Major surgery within 4 weeks before randomization
The last dose of prior chemotherapy received less than 3 weeks prior to randomization
Radiation therapy not completed prior to the first dose of vandetanib
Significant cardiac event, superior vena cava syndrome, NYHA classification of heart disease ≥2, within 12 weeks before randomization, or presence of cardiac disease that in the opinion of the Investigator increases risk of ventricular arrhythmia
Creatinine clearance <30 ml/min (calculated by Cockcroft-Gault formula),Patients with moderate renal impairment, defined as creatinine clearance ≥30 to <50 ml/min, must start vandetanib at a reduced dose of 200 mg

Trial locations and contacts

66 sites in 20 countries.

Country

City, postcode or hospital

66 sites in 20 countries

Canada6 sites

Investigational Site Number : 1001
London, Ontario, N6A 4L6
Investigational Site Number 1001
London, N6A 4L6
Investigational Site Number : 1002
Sherbrooke, Quebec, J1H 5N4
Investigational Site Number 1002
Sherbrooke, J1H 5N4
Investigational Site Number : 1003
Toronto, Ontario, M5G2M9
Investigational Site Number 1003
Toronto, M5G2M9

Other trials in Canada

Germany6 sites

Investigational Site Number 2602
Essen, 45122
Investigational Site Number : 2602
Essen, 45122
Investigational Site Number 2603
Halle, 06120
Investigational Site Number : 2603
Halle, 06120
Investigational Site Number 2601
Würzburg, 97080
Investigational Site Number : 2601
Würzburg, 97080

Other trials in Germany

Italy6 sites

Investigational Site Number 4104
Naples
Investigational Site Number : 4104
Naples
Investigational Site Number 4101
Pisa, 56124
Investigational Site Number : 4101
Pisa, 56124
Investigational Site Number 4102
Roma, 00161
Investigational Site Number : 4102
Roma, 00161

Other trials in Italy

Russia6 sites

Investigational Site Number 6201
Moscow, 115478
Investigational Site Number : 6201
Moscow, 115478
Investigational Site Number 6204
Moscow, 125284
Investigational Site Number 6202
Obninsk, 249036
Investigational Site Number : 6202
Obninsk, 249036
Investigational Site Number 6203
Saint Petersburg, 197022

Other trials in Russia

Brazil4 sites

Hospital De Clinicas De Porto Alegre Site Number : 701
Porto Alegre, Rio Grande do Sul, 90035-003
Investigational Site Number 701
Porto Alegre, 90035-003
Faculdade de Medicina de Ribeirao Preto - USP Site Number : 702
Ribeirão Preto, São Paulo, 14048-900
Investigational Site Number 702
Ribeirão Preto, 14048-900

Other trials in Brazil

China4 sites

Investigational Site Number 1301
Beijing, 100021
Investigational Site Number : 1301
Beijing, 100021
Investigational Site Number 1302
Shanghai
Investigational Site Number : 1302
Shanghai

Other trials in China

India4 sites

Investigational Site Number 3501
Mumbai, 400012
Investigational Site Number : 3501
Mumbai, 400012
Investigational Site Number 3502
Vellore, 632004
Investigational Site Number : 3502
Vellore, 632004

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Poland4 sites

Investigational Site Number : 5702
Poznan, Greater Poland Voivodeship, 60-355
Investigational Site Number 5702
Poznan, 60-355
Investigational Site Number : 5703
Warsaw, Masovian Voivodeship, 02-781
Investigational Site Number 5703
Warsaw, 02-781

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United Kingdom4 sites

Investigational Site Number 2802
Glasgow, G120YN
Investigational Site Number : 2802
Glasgow, G120YN
Investigational Site Number : 2801
Sutton, Surrey, SM25PT
Investigational Site Number 2801
Sutton, SM25PT

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Australia2 sites

Investigational Site Number : 301
St Leonards, New South Wales, 2065
Investigational Site Number 301
St Leonards, 2065

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Austria2 sites

Investigational Site Number 401
Vienna, 1901
Investigational Site Number : 401
Vienna, 1901

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Belgium2 sites

Investigational Site Number : 501
Anderlecht, 1070
Investigational Site Number 501
Brussels, 1000

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Bulgaria2 sites

Investigational Site Number 901
Sofia, 1527
Investigational Site Number : 901
Sofia, 1527

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Czechia2 sites

Investigational Site Number 1901
Prague, 15006
Investigational Site Number : 1901
Prague, 15006

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Denmark2 sites

Investigational Site Number 2001
Odense C, 5000
Investigational Site Number : 2001
Odense C, 5000

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Finland2 sites

Investigational Site Number 2201
Helsinki, FI-00029
Investigational Site Number : 2201
Helsinki, FI-00029

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Greece2 sites

Investigational Site Number 3001
Athens, 11528
Investigational Site Number : 3001
Athens, 11528

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Israel2 sites

Investigational Site Number 4001
Jerusalem, 91120
Investigational Site Number : 4001
Jerusalem, 91120

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South Korea2 sites

Investigational Site Number : 6001
Seoul, 03080
Investigational Site Number 6001
Seoul

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Sweden2 sites

Investigational Site Number 7201
Uppsala, 75185
Investigational Site Number : 7201
Uppsala, 75185

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About this study

Official title: A Randomized,Int.,Open-Label Phase III Study to Assess the Effect of a Patient Outreach Program on the Percentage of Time Patients With Locally Advanced or Metastatic MTC Experience Grade 2 or Higher AEs in the First 12 Months of Treatment With Vandetanib

Conditions: Locally Advanced or Metastatic Medullary Thyroid Cancer, Medullary Thyroid Cancer
Being tested: Patient outreach, Vandetanib
Keywords: Medullary Thyroid Cancer, Locally advanced, Metastatic, Vandetanib, Patient Outreach
Medical subject headings: Carcinoma, Medullary, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Patient outreachBehavioural
Patients will be contacted at week 1 and then every 2 weeks until completion of 52 weeks to detect/treat AEs sooner
VandetanibDrug
Also called SAR390530
Treatment 300mg vandetanib opel label.

Study groups in NCT01298323
Study group	Role	What they receive
Vandetanib Control	Active comparator	Control - treatment 300mg vandetanib opel label Receives: Drug: Vandetanib
Experimental	Experimental	Experimental - treatment 300mg vandetanib opel label Receives: Behavioral: Patient outreach; Drug: Vandetanib

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Time a Patient Experienced at Least 1 AE of CTCAE Grade >=2 in First 12 Months of Receiving Vandetanib in Patients Who Participated in Patient Outreach Program.
The primary endpoint is the percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of treatment with vandetanib. If the patient discontinues treatment with vandetanib prior to the 12-month time point for any reason, this endpoint will be the time a patient experienced at least one AE of CTCAE grade 2 or higher as a percentage of the time the patient was receiving vandetanib.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Feb 201113 Mar 2025

First posted17 Feb 2011 (estimated)
Study start25 Feb 2011
Primary completion26 Apr 2013
Study completion13 Mar 2025

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 Locally Advanced or Metastatic Medullary 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 205 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01298323
Sponsor's protocol ID: D4200C00088
Other IDs: LPS14815, 2010-023428-26
Status last verified: Apr 2026
First submitted: 16 Feb 2011
Last updated: 17 Apr 2026
Results posted: Yes, on ClinicalTrials.gov

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized,Int.,Open-Label Phase III Study to Assess the Effect of a Patient Outreach Program on the Percentage of Time Patients With Locally Advanced or Metastatic MTC Experience Grade 2 or Higher AEs in the First 12 Months of Treatment With Vandetanib
ClinicalTrials.gov ID: NCT01298323
Acronym / sponsor ID: D4200C00088
Conditions: Locally Advanced or Metastatic Medullary Thyroid Cancer, Medullary Thyroid Cancer
Keywords: Medullary Thyroid Cancer, Locally advanced, Metastatic, Vandetanib, Patient Outreach
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 205 participants (actual)
Lead sponsor: SanofiIndustry (pharma, biotech, devices)
Study start: 25 Feb 2011 (actual)
Primary completion: 26 Apr 2013 (actual)
Study completion: 13 Mar 2025 (actual)
First posted: 17 Feb 2011 (estimated)
Results: Posted 24 Nov 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Vandetanib Control	Active comparator	Drug: VandetanibControl - treatment 300mg vandetanib opel label
Experimental	Experimental	Behavioral: Patient outreach, Drug: VandetanibExperimental - treatment 300mg vandetanib opel label

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Provision of informed consent prior to any study specific procedures
Female or male aged 18 years and over
Previously confirmed histological diagnosis of unresectable, locally advanced or metastatic hereditary or sporadic MTC. Documentation must be provided in patient's medical chart
WHO or ECOG Performance status 0-2
Negative pregnancy test (urine or serum) for female patients of childbearing potential

Key exclusion criteria (6 listed)

Unstable brain metastases or spinal cord compression that require treatment, unless treated at least 4 weeks before first dose and stable without steroid treatment for 10 days
Major surgery within 4 weeks before randomization
The last dose of prior chemotherapy received less than 3 weeks prior to randomization
Radiation therapy not completed prior to the first dose of vandetanib
Significant cardiac event, superior vena cava syndrome, NYHA classification of heart disease ≥2, within 12 weeks before randomization, or presence of cardiac disease that in the opinion of the Investigator increases risk of ventricular arrhythmia

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
Patient outreachPatients will be contacted at week 1 and then every 2 weeks until completion of 52 weeks to detect/treat AEs sooner	Behavioural	Experimental
VandetanibAlso: SAR390530Treatment 300mg vandetanib opel label.	Drug	Experimental, Vandetanib Control

Primary outcome

Percentage of Time a Patient Experienced at Least 1 AE of CTCAE Grade >=2 in First 12 Months of Receiving Vandetanib in Patients Who Participated in Patient Outreach Program.
Time frame: 12 months
The primary endpoint is the percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of treatment with vandetanib. If the patient discontinues treatment with vandetanib prior to the 12-month time point for any reason, this endpoint will be the time a patient experienced at least one AE of CTCAE grade 2 or higher as a percentage of the time the patient was receiving vandetanib.

Results and safety

Results posted to the registry on 24 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vandetanib 300 mg	102	77
Vandetanib 300 mg + Outreach Program	103	78

Primary outcome: Percentage of Time a Patient Experienced at Least 1 AE of CTCAE Grade >=2 in First 12 Months of Receiving Vandetanib in Patients Who Participated in Patient Outreach Program.

Time frame: 12 months. Mean (Standard Deviation). Unit: Percentage of days

Measure	Vandetanib 300 mg+Outreach Program n = 102	Vandetanib 300 mg n = 103
Value	51.65 (35.548)	45.19 (36.347)

Vandetanib 300 mg+Outreach Program vs Vandetanib 300 mg: t-Statistic: 1.29 (95% CI -3.44 to 16.37), p = 0.199, t-test, 2 sided

Population analysed: Number of Months Analyzed is the cumulative sum of number of months that all the participants were present in the study.

Adverse events

Time frame: Adverse events (AEs) and all-cause mortality (deaths) were collected from randomization (Day 1) up to end of follow-up for each patient, approximately 168 months. Non-serious AEs were not collected during the continuing treatment period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Randomized Treatment Period: Vandetanib 300 mg + Outreach Program	27 of 102 (26.5%)	96 of 102 (94.1%)	16 of 102
Randomized Treatment Period: Vandetanib 300 mg	31 of 103 (30.1%)	89 of 103 (86.4%)	11 of 103
Continuing Treatment Period: Vandetanib 300 mg + Outreach Program	18 of 55 (32.7%)	0 of 0	7 of 55
Continuing Treatment Period: Vandetanib 300 mg	21 of 55 (38.2%)	0 of 0	7 of 55

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
D4200C00088\_CSR\_SynopsisLink provided by the sponsor.

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 director

Sanofi

66 sites in 20 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Patient outreach and Vandetanib in people with Locally Advanced or Metastatic Medullary Thyroid Cancer and Medullary Thyroid Cancer, run by Sanofi at 66 sites in 20 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 6 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 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in Canada, Germany, Italy, Russia, Brazil and 15 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 24 Nov 2014). 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?

Percentage of Time a Patient Experienced at Least 1 AE of CTCAE Grade >=2 in First 12 Months of Receiving Vandetanib in Patients Who Participated in Patient Outreach Program. (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01298323.

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 17 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.