NL-OMON55301已完成不适用
Reinducing radioiodine-sensitivity in radioiodine-refractory thyroid cancer using lenvatinib - RESET
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria:
- •Age >= 18 years at the time of informed consent
- •Histologically or cytologically confirmed DTC (including papillary,
- •follicular or Hürthle Cell carcinoma)
- •Progressive (biochemical or anatomic) disease for which lenvatinib is started
- •as standard treatment at the discretion of the treating physician.
- •Measurable disease at baseline imaging (F-18 FDG PET) according to the
- •definition of the Positron Emission Tomography Response Criteria in Solid
- •Tumors (PERCIST) 1.0 with at least one lesion >=1.0 cm in the longest diameter
- •for a non-lymph node or >=1.5 cm in the short axis for a lymph node.
- •RAI-R disease on structural imaging, defined as any one of the following:
- •o Metastatic lesions that are not RAI-avid on a diagnostic or intra-therapeutic
- •RAI scan performed prior to enrolment in the current study
- •o RAI-avid metastatic lesions which remained stable in size or progressed
- •according to RECIST 1.1 criteria despite RAI treatment. Absence of response is
- •observed during 6-9 months after high dose I-131 therapy.
- •No recent treatment for thyroid cancer:
- •o No prior I-131 therapy is allowed <6 months prior to initiation of therapy on
- •this protocol (a diagnostic study using <400 MBq of I-131 is not considered
- •131I therapy)
- •o No external beam radiation therapy is allowed <4 weeks prior to initiation of
- •therapy on this protocol. (Previous treatment with radiation for any indication
- •is allowed if the investigator judges that the previous radiation does not
- •significantly compromise patient safety on this protocol)
- •Eastern Cooperative Oncology Group (ECOG) performance status <=2 (or Karnofsky
- •Life expectancy >=3 months
- •Ability to swallow and retain orally-administered medication and no
- •clinically significant gastrointestinal abnormalities that may alter absorption
- •Creatinine <=1.5 mg/dL (<=133 µmol/L) or estimated glomerular filtration rate
- •(eGFR) (using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
- •formula) >=50 mL/min/1.73m2 or 24-hour urine creatinine clearance >=50
- •mL/min/1.73m2
- •Adequate blood coagulation function as evidenced by an international
- •normalized ratio (INR) <=1.5
- •Adequate bone marrow function with:
- •o Absolute neutrophil count >=1.5 * 10^9/L
- •o Hemoglobin >=9 g/dL (5.6 mmol/L)
- •o Platelets >=100 *10^9/L
- •Adequate liver function with
- •o Albumin >=25 g/L
- •o Total bilirubin <1.5x institutional upper limit of normal (ULN) with an
- •exception for patients with Gilbert*s syndrome
- •o Aspartate aminotransferase and alanine aminotransferase <=3x institutional ULN
- •(<=5x ULN if subject has liver metastases)
- •Negative pregnancy test within 7 days prior to starting the study for
- •premenopausal women. Women can be included without pregnancy test if they are
- •either surgically sterile or have been post-menopausal for >=1 year.
- •Sexually active women of childbearing potential must agree to use a highly
- •effective method of contraception during the study and for at least 6 months
- 另有 4 项未显示
排除标准
- •Concomitant or previous malignancies within the last 3 years. Patients are
- •eligible for this study if they have been disease-free of the previous
- •malignancy for at least 3 years, have a history of completely resected
- •non-melanoma skin cancer and/or have indolent secondary malignancies.
- •Symptomatic or untreated leptomeningeal or brain metastases or spinal cord
- •compression
- •Evidence of cardiovascular risk including any of the following:
- •o Clinically relevant arrhythmias
- •o Acute coronary syndromes, severe/unstable angina
- •o Symptomatic congestive heart failure
- •Use of other investigational drugs within 28 days preceding the first dose of
- •treatment in this study or during the study
- •Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy
- •to drugs chemically related to lenvatinib and/or to Thyrotropin alfa (human
- •recombinant thyrotropin)
- •or other known contents of the two drugs.
- •Inability to follow a low iodine diet or requiring medication with high
- •content in iodide (e.g. amiodarone)
- •Patients who received iodinated intravenous contrast as part of a
- •radiographic procedure within 6-8 weeks of study registration. Patients are
- •eligible for this study if urinary iodine analysis reveals that the excess
- •iodine has been adequately cleared after the last intravenous contrast
- •administration
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or
- •active infection or psychiatric illness/social situations that would limit
- •compliance with study requirements.
- •Pregnant, lactating or breast feeding women
- •Any medical or other condition that in the opinion of the investigator(s)
- •would preclude the participation in a clinical study
- •Unwillingness or inability to comply with study and follow-up procedures.
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