NCT01964144已完成2 期
An Open-label, Multicenter, Phase II Study of Dovitinib in Advanced Thyroid Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
There has been no effective treatment for advanced thyroid cancer that is not amenable to surgery and that does not concentrate iodine. Response rates with chemotherapy have been so low that best supportive care has been the standard of care for most patients. In recent phase I and phase II clinical studies, dovitinib has shown activity as a single agent in solid tumors. Therefore, we will conduct a phase II, single-arm trial to determine the efficacy of dovitinib in radioactive iodine-refractory recurrent or metastatic thyroid cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven diagnosis of thyroid cancer (papillary, follicular/Hürthle cell variant, medullary)
- •Patients with metastatic or unresectable thyroid cancer for which curative measures (surgical resection, external-beam radiation therapy, or radioactive iodine) were no longer effective
- •Documented evidence of disease progression (based on radiographic imaging), according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, within 6 months before entry into the study for papillary follicular/Hürthle cell variant
- •Prior therapy with surgery, 131I treatment, chemotherapy, radiotherapy will be allowed, but not within 3 weeks of treatment.
- •Patients who received a prior biologic treatment (kinase inhibitor, vaccine or antibody-based therapy), except prior VEGFR/FGFR inhibitor therapy, can be allowed after 3 weeks of treatment.
- •Patients must have at least one measurable lesion, which has not been externally irradiated, as defined by RECIST criteria version 1.1
- •Age : 20-90
- •Performance status of Eastern Cooperative Oncology Group 0 to 2
- •Life expectancy > 3 months
- •Adequate bone marrow function: ANC≥1,500/uL, hemoglobin≥9.0 g/dL (can be corrected by transfusion) and platelet≥100,000/uL
- •Adequate renal function (creatinine<1.5 mg/dL)
- •Adequate liver function (total bilirubin <1.5 x ULN, trans-aminase <3 x ULN)
- •Adequate blood glucose and lipid level (at fasting cholesterol < 2xUNL, triglyceride < 2xUNL, HbA1c < 9%)
- •Patient compliance and geographic proximity that allow adequate follow up
排除标准
- •Patients with CNS metastases
- •Patients with another primary malignancy within 3 years prior to starting study drug, with the exception of adequately treated in-situ carcinoma of the uterine cervix, or skin cancer (such as basal cell carcinoma, squamous cell carcinoma, or non-melanomatous skin cancer)
- •Patients who have received the last administration of an anticancer therapy including chemotherapy, immunotherapy, hormonal therapy and monoclonal antibodies (but excluding nitrosurea, mitomycin-C, targeted therapy and radiation) ≤ 4 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy
- •Patients who have received the last administration of nitrosurea or mitomycin-C ≤ 6 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy
- •Patients who have received targeted therapy (e.g. sunitinib, sorafenib, pazopanib) ≤ 2 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy
- •Patients who have had radiotherapy ≤ 4 weeks prior to starting study drug, or ≤ 2 weeks prior to starting study drug in the case of localized radiotherapy (e.g. for analgesic purpose or for lytic lesions at risk of fracture), or who have not recovered from radiotherapy toxicities
- •Pregnant or breast-feeding women
- •Fertile males not willing to use contraception, as stated above
- •Patients unwilling or unable to comply with the protocol
研究组 & 干预措施
Dovitinib arm
Experimental
干预措施: Dovitinib (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: 1 month after treatment
Lesions measurements are performed by CT or MRI scan, evaluation by RECIST criteria v1.1
次要结局
未报告次要终点
研究者
研究点 (1)
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