To Compare The Effects Of Two Doses Of Vandetanib In Patients With Advanced Medullary Thyroid Cancer
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
3 other identifiers
interventional
81
9 countries
30
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2012
Longer than P75 for phase_4
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2011
CompletedFirst Posted
Study publicly available on registry
December 21, 2011
CompletedStudy Start
First participant enrolled
June 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 2, 2014
CompletedResults Posted
Study results publicly available
November 27, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 11, 2024
CompletedOctober 3, 2025
September 1, 2025
1.8 years
December 2, 2011
April 1, 2015
September 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Randomisation to week 60 (maximum)
Secondary Outcomes (5)
Best Objective Response
Randomisation to week 60 (maximum)
Duration of Objective Response (RECIST 1.1) by Treatment Arm
Randomization to Week 60 (maximum)
Time to Objective Response (RECIST 1.1) by Treatment Arm
Randomization to Week 60 (maximum)
Percentage Change From Baseline in Target Lesion Size (RECIST 1.1) by Treatment Arm
Randomization to Week 60 (maximum)
Plasma Concentration of Vandetanib in the Bloodstream (Cmax) for Patients by Treatment Arm.
Week 3 to week 60 (maximum)
Study Arms (2)
300mg vandetanib
ACTIVE COMPARATOR150mg vandetanib
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (30)
Research Site
Houston, Texas, United States
Investigational Site Number : 1903
Olomouc, 77900, Czechia
Research Site
Olomouc, Czechia
Investigational Site Number : 1901
Prague, 15006, Czechia
Research Site
Prague, Czechia
Research Site
Bangalore Karnataka, India
Research Site
Vellore, India
Research Site
Beersheba, Israel
Research Site
Haifa, Israel
Research Site
Jerusalem, Israel
Research Site
Petah Tikva, Israel
Research Site
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
Groningen, Netherlands
Research Site
Leiden, Netherlands
Investigational Site Number : 5704
Warsaw, Masovian Voivodeship, 02-781, Poland
Investigational Site Number : 5703
Gliwice, 44-101, Poland
Research Site
Gliwice, Poland
Research Site
Warsaw, Poland
Research Site
Zgierz, Poland
Research Site
Saint Petersburg, Russia
Research Site
Cardiff, United Kingdom
Research Site
Greater London, United Kingdom
Research Site
London, United Kingdom
Research Site
Tyne & Wear, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Trial Transparency Team
- Organization
- Sanofi aventis recherche & développement
Study Officials
- STUDY CHAIR
Clinical Sciences & Operations
Sanofi
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2011
First Posted
December 21, 2011
Study Start
June 8, 2012
Primary Completion
April 2, 2014
Study Completion
July 11, 2024
Last Updated
October 3, 2025
Results First Posted
November 27, 2015
Record last verified: 2025-09