2023-504150-35-00招募中4 期
Akynzeo as antiemetic treatment in patients with endometrial cancer treated with taxane - platinum combination chemotherapy. NOEME study.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 8
- 主要终点
- Proportion of patients achieving complete response (CR: no emesis, no rescue medication) during the overall phase (0-120h) at cycle 1.
研究概览
简要总结
To evaluate effectiveness of a single oral dose of NEPA in terms of complete response (CR: no emesis, no rescue medication) in the overall phase (0-120h) at cycle 1 in chemotherapy-naïve patients with endometrial cancer receiving paclitaxel and carboplatin with or without immunotherapy.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is at least 18 years of age, able to understand the study procedures, and agrees to participate in the study by providing written informed consent.
- •Subject has histologically or cytologically proven endometrial cancer.
- •Patients were required to have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or
- •Adequate organ function allowing the patient to receive taxane-platinum combination therapy with or without immunotherapy according to clinical practice and opinion of treating physician.
- •Naive to chemotherapy.
排除标准
- •Patients will experience emesis within the 24 hours before receipt of 1 course of chemotherapy.
- •Patients will be scheduled to radiation therapy to the abdomen or pelvis within 1 week before day 1 or between day 1 and
- •Patients will be scheduled to undergo bone marrow or stem-cell transplant.
- •Chronic systemic corticosteroid use.
- •Brain metastasis.
- •Subject is considered a poor medical risk due to a serious, uncontrolled medical disorder.
- •History or predisposition to cardiac conduction abnormalities, torsade des pointes or severe cardiovascular diseases.
- •Subject is pregnant or breastfeeding or is expecting to conceive children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of study treatment.
结局指标
主要结局
Proportion of patients achieving complete response (CR: no emesis, no rescue medication) during the overall phase (0-120h) at cycle 1.
Proportion of patients achieving complete response (CR: no emesis, no rescue medication) during the overall phase (0-120h) at cycle 1.
次要结局
- Proportion of patients achieving a complete response and complete control during the acute (0–24 h), delayed phase (>24 to 120 h) and overall (0-120h) phases of each cycle after the start of chemotherapy.
- Proportion of patients achieving no rescue medication, no emesis and no significant nausea (VAS score of <25 mm) during the acute (0-24 hours), delayed (>24 to 120 hours), and overall (0-120 hours) after the start of chemotherapy of each cycle.
- Proportion of patients achieving CR and complete control during the acute (0-24 hours), delayed (>24 to 120 hours), and overall (0-120 hours) phases after the start of each cycle according to Patient Emetogenicity Risk Profile assessed with 10 CINV Risk Assessment tool in patients with endometrial cancer receiving paclitaxel and carboplatin regimen with or without immunotherapy.
- The safety and tolerability of study drug (NEPA) will be evaluated based on AE reports, physical examination results (including vital signs), and clinical laboratory results by means of the occurrence, nature and severity of AEs.
研究者
Dr. Monika Ducceschi
Scientific
Fondazione IRCCS Istituto Nazionale Dei Tumori
研究点 (8)
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