NL-OMON47685已完成2 期
A phase II study exploring the safety and efficacy of nintedanib (BIBF1120) as second line therapy for patients with eitherc differentiated and medullary thyroid carcinoma progressing after first line therapy. - EORTC protocol 1209-EnTF
European Organisation for Research in Treatment of Cancer (EORTC)0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
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
- •* Histologically confirmed differentiated or medullary thyroid cancer by
- •local pathologist.
- •* Available tumor tissue at the time of initial diagnosis for histology
- •* 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
排除标准
- •* 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
- •* 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.
研究者
相似试验
进行中（未招募）
1 期
A phase II study of second line therapy on safety and efficacy of nintedanib for patients with either differentiated or medullary thyroid cancer progressing after first line therapy.Histologically confirmed differentiated or medullary thyroid cancer by local pathologist.MedDRA version: 17.0Level: PTClassification code 10027105Term: Medullary thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: PTClassification code 10066474Term: Thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: PTClassification code 10033701Term: Papillary thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-004295-19-FREuropean Organisation for Research and Treatment of Cancer. EORTC102
进行中（未招募）
1 期
A phase II study of second line therapy on safety and efficacy of nintedanib for patients with either differentiated or medullary thyroid cancer progressing after first line therapy.EUCTR2012-004295-19-BEEuropean Organisation for Research and Treatment of Cancer (EORTC)102
进行中（未招募）
1 期
A phase II study of second line therapy on safety and efficacy of nintedanib for patients with either differentiated or medullary thyroid cancer progressing after first line therapy.EUCTR2012-004295-19-DKEuropean Organisation for Research and Treatment of Cancer (EORTC)142
进行中（未招募）
1 期
A phase II study of second line therapy on safety and efficacy of nintedanib for patients with either differentiated or medullary thyroid cancer progressing after first line therapy.Histologically confirmed differentiated or medullary thyroid cancer by local pathologist.MedDRA version: 21.1Level: PTClassification code 10027105Term: Medullary thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10066474Term: Thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10033701Term: Papillary thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-004295-19-GBEuropean Organisation for Research and Treatment of Cancer (EORTC)102
进行中（未招募）
1 期
A phase II study of second line therapy on safety and efficacy of nintedanib for patients with either differentiated or medullary thyroid cancer progressing after first line therapy.EUCTR2012-004295-19-ESEuropean Organisation for Research and Treatment of Cancer. EORTC102