Phase I Study (First in Humans) of the Amblyomin-X in the Treatment of Patients With Advanced Solid Tumors Refractory or Without Indication / Access to Standard Treatment

União Química Farmacêutica Nacional S/A2 个研究点分布在 1 个国家目标入组 24 人开始时间: 2021年2月15日最近更新: 2019年10月14日

适应症

干预措施

试验速览

阶段: 1 期
状态: 暂停
发起方: União Química Farmacêutica Nacional S/A
入组人数: 24
试验地点: 2
主要终点: grade 4 or non-haematological grade 3 haematological toxicity according to the CTCAE (version 4)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Amblyomin-X is an inhibitor of Factor Xa that also acts as an apoptotic agent for tumor cells. In the case of in vitro assays, Amblyomin-X induces tumor cells to death and does not affect the viability of normal cells. When in vivo assays were performed on mice bearing tumors, treatment with Amblyomin-X caused a significant reduction in tumor mass and number of metastases.

详细描述

This trial will be the first clinical study in humans with the product, which until then has been studied only in experimental models. Given the current epidemiological impact of cancer and the need to improve its systemic treatment, making it available to a larger portion of the Brazilian population, it is proposed to conduct the first Amblyomin-X study in cancer patients, more specifically those with advanced solid tumors For which there is no contraindicated or inaccessible therapeutic option established as the standard at the time of inclusion in the study.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Sequential
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Eligible patients must sign the Free and Informed Consent Term (TCLE),
•be between 18 and 75 years of age,
•present a solid tumor proven by anatomopathological examination at an advanced or metastatic stage and refractory to conventional treatment or without current indication or access to conventional treatment ,
•have a life expectancy of at least 12 weeks.
•presence of measurable disease according to Response Response Criteria in Solid Tumors (RECIST, version 1.1),
•medullary, renal and hepatic functions within acceptable limits (defined in protocol),
•end of the previous antineoplastic treatment at least 4 weeks (since the last dose of any antineoplastic medication, radiotherapy, or surgical procedure).

排除标准

•The presence of previously non-irradiated brain metastasis;
•Prediction of the use of radiotherapy, surgery, systemic antineoplastic treatment, or any other form of treatment for cancer after inclusion in the study;
•Prediction of corticosteroid use, hematopoietic growth factors or inhibitors of bone resorption during the first course of treatment (4 weeks);
•Regular use of anticoagulants or known previous coagulation disorder;
•Severe comorbidity (at the discretion of the researcher);
•Gestational, lactating, pregnant women, or who have not been surgically infertile or menopausal for at least 12 months;
•Men and women who refuse to use an adequate contraceptive method during the study period;
•Participation of another clinical study in the last 12 months (unless justified by the investigator);
•Or inability to comply with study requirements and procedures.

研究组 & 干预措施

Cohort 6

Experimental

This cohort will include 3 patients with the sixth calculated dose of Amblyomin-X drug, the last dose calculated. The patient will receive the intravenous drug.