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Completed

NCT Number: NCT01496313

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

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.

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Key information

Conditions

Thyroid Cancer Adenocarcinoma Carcinoma Carcinoma, Medullary Carcinoma, Neuroendocrine Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplastic Processes Neuroectodermal Tumors Neuroendocrine Tumors Pathologic Processes Pathological Conditions, Signs and Symptoms Thyroid Diseases Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Investigational Site Number : 1903, Olomouc, Czechia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

300mg vandetanib

Drug

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

150mg vandetanib

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Best Objective Response

    Time frame: Randomisation to week 60 (maximum)

  2. Duration of Objective Response (RECIST 1.1) by Treatment Arm

    Time frame: Randomization to Week 60 (maximum)

  3. Time to Objective Response (RECIST 1.1) by Treatment Arm

    Time frame: Randomization to Week 60 (maximum)

  4. Percentage Change From Baseline in Target Lesion Size (RECIST 1.1) by Treatment Arm

    Time frame: Randomization to Week 60 (maximum)

  5. Plasma Concentration of Vandetanib in the Bloodstream (Cmax) for Patients by Treatment Arm.

    Time frame: Week 3 to week 60 (maximum)

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2024
First posted
Dec 21, 2011
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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