To Compare The Effects Of Two Doses Of Vandetanib In Patients With Advanced Medullary Thyroid Cancer

September 16, 2025 updated by: Sanofi

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Olomouc, Czechia
        • Research Site
      • Olomouc, Czechia, 77900
        • Investigational Site Number : 1903
      • Prague, Czechia
        • Research Site
      • Prague, Czechia, 15006
        • Investigational Site Number : 1901
  • India
      • Bangalore Karnataka, India
        • Research Site
      • Vellore, India
        • Research Site
  • Israel
      • Beersheba, Israel
        • Research Site
      • Haifa, Israel
        • Research Site
      • Jerusalem, Israel
        • Research Site
      • Petah Tikva, Israel
        • Research Site
  • Italy
      • Catania, Italy
        • Research Site
      • Milan, Italy
        • Research Site
      • Palermo, Italy
        • Research Site
      • Pisa, Italy
        • Research Site
      • Roma, Italy
        • Research Site
      • Siena, Italy
        • Research Site
      • Torino, Italy
        • Research Site
  • Netherlands
      • Groningen, Netherlands
        • Research Site
      • Leiden, Netherlands
        • Research Site
  • Poland
      • Gliwice, Poland
        • Research Site
      • Gliwice, Poland, 44-101
        • Investigational Site Number : 5703
      • Warsaw, Poland
        • Research Site
      • Zgierz, Poland
        • Research Site
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-781
        • Investigational Site Number : 5704
  • Russia
      • Saint Petersburg, Russia
        • Research Site
  • United Kingdom
      • Cardiff, United Kingdom
        • Research Site
      • Greater London, United Kingdom
        • Research Site
      • London, United Kingdom
        • Research Site
      • Tyne & Wear, United Kingdom
        • Research Site
  • United States
    • Texas
      • Houston, Texas, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 300mg vandetanib
Drug: 300mg vandetanib

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.

Other Names:
  • SAR390530
Active Comparator: 150mg vandetanib
Drug: 150mg vandetanib

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.

Other Names:
  • SAR390530

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Randomisation to week 60 (maximum)

Secondary Outcome Measures

Outcome Measure
Time Frame
Best Objective Response
Time Frame: Randomisation to week 60 (maximum)
Randomisation to week 60 (maximum)
Duration of Objective Response (RECIST 1.1) by Treatment Arm
Time Frame: Randomization to Week 60 (maximum)
Randomization to Week 60 (maximum)
Time to Objective Response (RECIST 1.1) by Treatment Arm
Time Frame: Randomization to Week 60 (maximum)
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)
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)
Week 3 to week 60 (maximum)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Chair: Clinical Sciences & Operations, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2012

Primary Completion (Actual)

April 2, 2014

Study Completion (Actual)

July 11, 2024

Study Registration Dates

First Submitted

December 2, 2011

First Submitted That Met QC Criteria

December 19, 2011

First Posted (Estimated)

December 21, 2011

Study Record Updates

Last Update Posted (Estimated)

October 3, 2025

Last Update Submitted That Met QC Criteria

September 16, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4200C00097
  • 2011-004701-24 (EudraCT Number)
  • LPS14809 (Other Identifier: Sanofi Identifier)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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