To Compare The Effects Of Two Doses Of Vandetanib In Patients With Advanced Medullary Thyroid Cancer
Condition: Thyroid Cancer
MeSH terms: Thyroid Neoplasms; Thyroid Diseases
Intervention: 300mg vandetanib; 150mg vandetanib
Intervention description: 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.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: medullary thyroid cancer; metastatic; thyroid cancer; carcinoma of the thyroid; receptor tyrosine kinase inhibitor; VEGFR; Unresectable locally advanced thyroid cancer

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.
    

Eligibility criteria:

        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.