To Compare The Effects Of Two Doses Of Vandetanib In Patients With Advanced Medullary Thyroid Cancer
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ClinicalTrials.gov Identifier: NCT01496313 |
Recruitment Status :
Active, not recruiting
First Posted : December 21, 2011
Results First Posted : November 27, 2015
Last Update Posted : March 4, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Thyroid Cancer | Drug: 300mg vandetanib Drug: 150mg vandetanib | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 81 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | June 2012 |
Actual Primary Completion Date : | April 2014 |
Estimated Study Completion Date : | December 30, 2020 |

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 Name: 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 Name: SAR390530 |
- 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
- 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) ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01496313
United States, Texas | |
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Houston, Texas, United States | |
Czechia | |
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Olomouc, Czechia | |
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Praha 5, Czechia | |
India | |
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Bangalore Karnataka, India | |
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Vellore, India | |
Israel | |
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Beer Sheva, Israel | |
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Haifa, Israel | |
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Jerusalem, Israel | |
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Petach Tikva, Israel | |
Italy | |
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Catania, Italy | |
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Milano, Italy | |
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Palermo, Italy | |
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Pisa, Italy | |
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Roma, Italy | |
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Siena, Italy | |
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Torino, Italy | |
Netherlands | |
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Groningen, Netherlands | |
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Leiden, Netherlands | |
Poland | |
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Gliwice, Poland | |
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Warszawa, Poland | |
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Zgierz, Poland | |
Russian Federation | |
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Saint Petersburg, Russian Federation | |
United Kingdom | |
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Cardiff, United Kingdom | |
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Greater London, United Kingdom | |
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London, United Kingdom | |
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Tyne & Wear, United Kingdom |
Study Chair: | Clinical Sciences & Operations | Sanofi |
Responsible Party: | Genzyme, a Sanofi Company |
ClinicalTrials.gov Identifier: | NCT01496313 |
Other Study ID Numbers: |
D4200C00097 2011-004701-24 ( EudraCT Number ) LPS14809 ( Other Identifier: Sanofi ) |
First Posted: | December 21, 2011 Key Record Dates |
Results First Posted: | November 27, 2015 |
Last Update Posted: | March 4, 2020 |
Last Verified: | February 2020 |
medullary thyroid cancer metastatic thyroid cancer carcinoma of the thyroid |
receptor tyrosine kinase inhibitor VEGFR Unresectable locally advanced thyroid cancer |
Thyroid Neoplasms Thyroid Diseases Endocrine System Diseases Endocrine Gland Neoplasms |
Neoplasms by Site Neoplasms Head and Neck Neoplasms |