NCT03573960已完成4 期
Prospective Single Arm Post Marketing Phase IV Study to Assess the Safety and Efficacy of Lenvatinib in Subjects With Locally Recurrent or Metastatic, Progressive, Radioiodine Refractory Differentiated Thyroid Cancer
Eisai Pharmaceuticals India Pvt. Ltd11 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 11
- 主要终点
- Percentage of Participants with Grade 2 or Higher Treatment-emergent Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the safety of lenvatinib in participants with recurrent, metastatic radio-iodine refractory differentiated thyroid cancer (DTC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females who are diagnosed with locally Recurrent or Metastatic, Progressive, Radioiodine Refractory DTC, Lenvatinib naive and able to provide written informed consent.
- •Histologically or cytologically confirmed diagnosis of one of the following DTC subtypes: Papillary thyroid cancer (PTC) (including the follicular variants and other variants), Follicular thyroid cancer (FTC) (including Hurthle cell, Clear cell and Insular subtypes).
- •Measurable disease meeting the following criteria: i) At least 1 lesion >= 1.0 centimeter (cm) in the longest diameter for a non-lymph node or >= 1.5 cm in the short-axis diameter for a lymph node which is serially measurable according to RECIST 1.1 using computerized tomography/magnetic resonance imaging (CT/MRI). ii) Lesions that have had external beam radiotherapy (EBRT) or locoregional therapies such as radiofrequency (RF) ablation must have shown evidence of PD based on RECIST 1.1 to be deemed a target lesion.
- •Evidence of disease progression within 12 months of screening scan.
- •Require thyroxine suppression therapy and thyroid stimulating hormone (TSH) should not be elevated (TSH should be less than [<] 4.0 milli-international units per liter [mIU/L]).
- •Participant must be radioiodine-refractory or resistant within 12 months of radioiodine therapy and have one of the following:
- •One or more measurable lesions that do not demonstrate iodine uptake on any radioiodine scan.
- •One or more measurable lesions that have substantially increased in size within 12 months of radioiodine therapy, despite demonstration of radioiodine activity at the time of that treatment by pre- or post-treatment scanning.
- •Cumulative activity of radioiodine of greater than (>) 600 milliecurie (mCi) or 22 gigabecquerels (GBq), with the last dose administered at least 6 months prior to study entry.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Based on following laboratory assessment:
- •Creatinine clearance >= 30 milliliter per minute (mL/min) according to the Cockcroft and Gault formula.
- •Adequate blood coagulation function as evidenced by an International Normalized Ratio (INR) less than or equal to (<=) 1.
- •Adequate bone marrow function:
- •i. Absolute neutrophil count (ANC) >=1.5*10^9/liter (L) ii. Hemoglobin >= 9.0 gram per deciliter (g/dL) (can be corrected by growth factor or transfusion) iii. Platelet count >=100 * 10^9/L
- •Adequate liver function:
- •i. Bilirubin <= 1.5*upper limit of normal (ULN) except for unconjugated hyperbilirubinemia or Gilbert's syndrome.
- •ii. Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) <= 3*ULN (<= 5*ULN if participant has liver metastases). If ALP is > 3*ULN (in the absence of liver metastases) or > 5*ULN (in the presence of liver metastases) and participants are also known to have bone metastases, the liver-specific ALP must be separated from the total and used to assess the liver function instead of the total ALP.
- •Urine dipstick proteinuria should be < 2+. If > or equal 2 gram (g) proteinuria is detected with dipstick, a 24-hour period urine test will be performed and the result should be < or equal to 1 g/24 hours to permit the inclusion of the patient in the clinical trial.
- •Females of childbearing potential must not have had unprotected sexual intercourse within 30 days before program entry and must agree to use a highly effective method of contraception (example, total abstinence, an intrauterine device, a double-barrier method (such as condom plus diaphragm with spermicide), a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire program.
- •If currently abstinent, participants must agree to use a double-barrier method as described above if they become sexually active during the study period or for 30 days after study drug discontinuation.
- •Females who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation.
排除标准
- •Anaplastic or medullary carcinoma of the thyroid.
- •Two or more prior vascular endothelial growth factor (VEGF)/vascular endothelial growth factor receptor (VEGFR)-targeted therapies or any ongoing treatment for iodine-131 (131I) refractory DTC other than TSH-suppressive thyroid hormone therapy.
- •Blood pressure (BP) >= 140 millimeter of mercury (mmHg) Systolic and >= 90 mmHg Diastolic at screening with or without antihypertensive medications.
- •Woman who are lactating or pregnant at screening or baseline.
- •Participants who received any anticancer treatment within 21 days or any investigational agent within 30 days prior to the first dose of study drug. (This does not apply to the use of TSH-suppressive thyroid hormone therapy).
- •Gastrointestinal malabsorption or any other condition that in the opinion of the investigator affected the absorption of Lenvatinib.
- •Participant has history of congestive heart failure with New York Heart Association (NYHA) Classification > II, unstable angina, myocardial infarction, serious cardiac arrhythmia, or stroke within the past 6 months.
- •Electrocardiogram (ECG) with QT interval (QTc) interval >= 450 millisecond (msec). (According to Bazett's formula).
- •Bleeding or thrombotic disorders or use of anticoagulants, such as warfarin, or similar agents requiring therapeutic international normalized ration (INR) monitoring. (Treatment with low molecular weight heparin [LMWH] will be allowed).
- •Existing anti-cancer therapy-related toxicities of CTCAE version 4.03 grade >= 2, except alopecia and infertility.
- •Any history of or concomitant medical condition that, in the opinion of the investigator, would compromise participant's ability to safely complete the protocol.
- •Active infection (any infection requiring treatment).
- •Active malignancy (except for differentiated thyroid carcinoma, or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 24 months.
- •Epistaxis or active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.
- •Known intolerance to Lenvatinib (or any of the excipients).
- •Participants with clinically significant laboratory investigations as per the investigator's judgment.
- •Participation in any interventional clinical study within the past 90 days of enrollment to treatment.
- •Male or female of childbearing potential, unwilling to use adequate methods of contraception throughout the study.
- •Participants whom had major surgery within 3 weeks prior to study entry, or who have not recovered from prior major surgery, or whom have surgery scheduled during the course of the study.
研究组 & 干预措施
Lenvatinib 24 mg
Experimental
Participants will receive 24 mg (two 10-mg capsules + one 4-mg capsule) orally, once daily with or without food in 28-day cycles until disease progression or until unacceptable toxicity occurs.
干预措施: Lenvatinib (Drug)
结局指标
主要结局
Percentage of Participants with Grade 2 or Higher Treatment-emergent Adverse Events
时间窗: Baseline up to Week 24
TEAEs are defined as undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment. Adverse events (AEs) will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 where grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activity of daily living (ADL), grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL, grade 4: Life-threatening consequences; urgent intervention indicated and grade 5: Death related to AE.
Number of Dose Reductions
时间窗: Baseline up to Week 24
The number of instances of participants having to reduce the dosage of study drug based on specified toxicities.
Median Time to First Dose Reduction
时间窗: Baseline up to Week 24
Time to first dose reduction is defined as the time period from the first dose to the first dose reduction. Median time taken for the first dose reduction and 95% confidence interval will be calculated and reported.
次要结局
- Percentage of Participants with Other TEAEs Below Grade 2(Baseline up to Week 24)
- Progression-free Survival (PFS)(From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurs first) or up to approximately Week 24)
- Objective Response Rate (ORR)(Week 24)
研究者
研究点 (11)
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