临床试验/NCT03509246

NCT03509246Unknown2 期

A Phase II Trial to Evaluate the Efficacy of Bortezomib and Pegylated Liposomal Doxorubicin in Patients With BRCA Wild-type Platinum-resistant Recurrent Ovarian Cancer

Seoul National University Hospital1 个研究点分布在 1 个国家目标入组 44 人开始时间: 2018年5月15日最近更新: 2020年1月14日

适应症

干预措施

试验速览

阶段: 2 期
发起方: Seoul National University Hospital
入组人数: 44
试验地点: 1
主要终点: Overall response rate

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

This study is a phase II clinical trial to evaluate the safety and efficacy of Bortezomib plus Pegylated liposomal doxorubicin combination therapy in a histologic type of high-grade serous carcinoma without BRCA mutation among patients with platinum-resistant recurrent ovarian cancer.

详细描述

Subjects are dosed with Bortezomib and PLD for a maximum of 6 cycles of 4 weeks. The response rate is evaluated with CT according to RECIST criteria ver 1.1. The efficacy and safety of the drug are assessed at the time of recurrence, at the time of death, or after 24 months after the end of the study drug administration.

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: 19 Years 至 —（Adult, Older Adult）
性别: Female
接受健康志愿者: 否

入选标准

•Patients diagnosed with epithelial ovarian cancer, fallopian tube cancer, or peritoneal cancer based on histologic findings obtained from biopsy/surgery and having a histologic type of high-grade serous cancer.
•In the absence of a mutation of the BRCA gene (no germline mutation should be identified, not in the case of a somatic mutation)
•Recurrence within 6 months after platinum-based chemotherapy.
•ECOG performance 2 points or less.
•Blood tests performed within 2 weeks of enrollment meet the following results: Neutrophil > 1,500/mm3; Platelet > 100,000/mm3; Hemoglobin > 9.0 g/dL; Total bilirubin < 1.5 x upper limit of normal (ULN); AST/ALT < 3.0 x ULN (or < 5 x ULM in case of liver metastases); Creatinine < 1.5 x ULN; Electrolytes should be within normal limits.
•Patients who understand the content of the study description and voluntarily agree in writing.
•Patients who are willing and able to adhere to the visit schedule, treatment plan, laboratory tests, and other testing procedures.

排除标准

•Patients previously treated with three or more anticancer regimens. Maintenance therapy is not considered a separate regimen (eg> paclitaxel-carboplatin-bevacizumab therapy). In the combined chemotherapy, when one drug is subtracted due to toxicity, the regimen is not counted as a change (Eg> paclitaxel-carboplatin chemotherapy, paclitaxel was discontinued due to neurotoxicity and carboplatin alone was not considered as a change of regimen).
•Previous refractory to ovarian cancer chemotherapy.
•Patients diagnosed with other tumors other than ovarian cancer for the last 5 years (not CIS).
•pregnant woman.
•Patients with uncontrolled infection.
•In the case of congenital immune disease or acquired immune deficiency syndrome.
•Women in lactation.
•History with Grade 3 or higher peripheral neuropathy.
•History of hypersensitivity reactions to PLD or bortezomib.
•If the physician is judged to have any serious illness or medical condition for which the patient is not suitable for the study.
•Patients with confirmed BRCA somatic mutations.
•Patients with acute diffuse infiltrative lung disease and cardiovascular disease.

研究组 & 干预措施

Pegylated liposomal doxorubicin plus Bortezomib combination

Experimental

At BRCA wild-type platinum-resistant recurrent ovarian cancer patients, Pegylated liposomal doxorubicin and Bortezomib combination therapy for six cycles.

干预措施: Pegylated liposomal doxorubicin plus Bortezomib (Drug)

结局指标

主要结局

Overall response rate

时间窗: up to 6yr

In the modified ITT group, the response rate to combination therapy with bortezomib and PLD 2

Partial response rate

时间窗: up to 6yr

The percentage of patients who received a confirmed treatment response over a partial response according to the RECIST criteria version 1.1 in the modified ITT analysis group. The evaluation is based on the researchers of each participating organization.

次要结局

Complete remission rate(up to 6yr)
Progression-free survival(up to 2yr)
Adverse drug reactions(up to 6yr)
Genetic susceptibility assessment(up to 6yr)
Overall survival(up to 6yr)
Response period(up to 5yr)
Quality of life(up to 6yr)

研究者

发起方

Seoul National University Hospital

申办方类型

Other

责任方

Sponsor

研究点 (1)

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