thyroid cancer thyroid carcinoma
Conditions
Interventions
Treatment cycles are defined as a four week period to facilitate scheduling of
visits and assessments. Treatment should start within 2 days from randomization.
Patients will receive drug in a blinded
Sponsors
European Organisation for Research in Treatment of Cancer (EORTC)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Histologically confirmed differentiated or medullary thyroid cancer by local pathologist. * Available tumor tissue at the time of initial diagnosis for histology review. * Locally advanced or metastatic disease deemed incurable by surgery, radiotherapy and/or radioactive iodine (RAI). * Patients must have measurable lesion with documented progression during the 12 months prior to randomization. * Patients must have received one or 2 prior line of treatment (but no more than two) and must be off treatment for at least 4 weeks prior to randomization. Patients with an MTC must have received one or 2 prior line of treatment (but no more than two) and must be off treatment for at least 4 weeks prior to randomization. If it is available and reimbursed in the respective country one of the prior lines of treatment needs to be with Vandetanib as long as there is no contraindication or the patient refuses the treatment with Vandetanib. * Age *18 years. * Performance status (PS) 0-1 (WHO, Appendix C). * Life expectancy of more than 12 weeks. * Adequate organ function, evidenced by the following laboratory results within 3 weeks prior to randomization
Exclusion criteria
Exclusion criteria: * Current symptomatic brain metastases or if previously present, must have been treated at least two months before randomization. * History of other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or basal cell or spinocellular carcinoma of the skin. * Ongoing treatment related toxicity due to prior treatment > grade I (except alopecia). * History of significant cardiac disease * Current uncontrolled hypertension * Evidence of active bleeding or bleeding diathesis. * Cerebrovascular accident at any time in the past, transient ischemic attack, deep venous thrombosis (DVT) or pulmonary embolism in the past 6 months * History of clinically significant gastrointestinal disorders . * Current severe, uncontrolled systemic disease or any other systemic disease/symptom that can hamper compliance with the protocol. * Major surgical procedure or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery. * History of receiving any investigational treatment within 28 days prior to randomization * Women or patients of child bearing potential who do not use any contraceptive methods * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. * No hypersensitivity to nintedanib, peanut or soya, or to any of the excipients of nintedanib. * Patients of childbearing / reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 3 months after the last dose of study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly. * Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until at least 3 months after the last dose of study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Progression free survival (RECIST 1.1) | — |
Secondary
| Measure | Time frame |
|---|---|
| * Secondary end-points * Response Rate (RECIST 1.1) * Duration of response * Exploration of the molecular mechanisms of action of drug * PFS at second progression (PFS-2) for patients crossing over from placebo to nintedanib. Safety * Toxicity profile (CTCAE version 4.0 will be used for adverse event reporting) | — |
Countries
Netherlands
Outcome results
None listed