A phase II study exploring the safety and efficacy of nintedanib (BIBF1120) as second line therapy for patients with either differentiated or medullary thyroid cancer progressing after first line therapy. - EORTC protocol 1209-EnTF

European Organisation for Research and Treatment of Cancer (EORTC)0 个研究点目标入组 102 人开始时间: 2013年10月18日最近更新: 2020年7月13日

适应症

试验速览

暂无简介。

•? 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 1
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1

•? 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.
•? Hypersensitivity to nintedanib, peanut or soya, or to any of the excipients of nintedanib.

发起方

European Organisation for Research and Treatment of Cancer (EORTC)