A Phase II, Single-Arm Study of Giredestrant in Patients with Grade 1 Endometrial Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 9
- 试验地点
- 5
- 主要终点
- 1. Regression rate at Month 6 assessment, defined as participants who have a decrease in the proportion of cancer or percentage of cancer is not increased but have an increase in non-cancer/non-atypical hyperplasia (%) at the Month 6 assessment compared with baseline
研究概览
简要总结
To evaluate the efficacy of giredestrant by regression rate at the Month 6 assessment and to evaluate the safety and tolerability of giredestrant
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Overall Design
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •Confirmed Grade 1 endometrial carcinoma (EC) of endometrioid histology for which participants are willing to receive 6-cycles of study therapy. An endometrial biopsy (EMB) or dilation and curettage (D&C) fresh collected within the screening period or archival sample collected within 3 months prior to screening must be provided to a central laboratory for histologic confirmation to determine eligibility
- •Magnetic resonance imaging (MRI)-confirmation of non-deeply invasive tumor (<50% myometrial invasion)
- •MRI or computed tomography (CT)-confirmation of no extrauterine disease
- •Willing to undergo a minimum of 6 continuous cycles of therapy before decision on surgery
- •Adequate hematologic and end-organ function
排除标准
- •Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 30 days after the final dose of giredestrant or within the time period specified per local prescribing guidelines after the final dose of the investigator’s choice of endocrine therapy
- •Treatment for cancer including but not limited to, chemotherapy, immunotherapy, cyclin-dependent kinase (CDK)4/6i, endocrine therapy, biologic therapy, or herbal therapy within 28 days prior to the initiation of study enrollment
- •Any gastrointestinal condition causing malabsorption or obstruction
- •Planned surgery, either for the treatment of cancer or any other surgery, during the study treatment period and up to 10 days after the completion of study treatment
- •Participants who have clinically significant liver disease consistent with Child-Pugh Class B or C, including active hepatitis, current alcohol abuse, cirrhosis, or positive test for viral hepatitis
- •Any serious medical condition or abnormality in clinical laboratory tests that precludes the participant’s safe participation in and completion of the study
结局指标
主要结局
1. Regression rate at Month 6 assessment, defined as participants who have a decrease in the proportion of cancer or percentage of cancer is not increased but have an increase in non-cancer/non-atypical hyperplasia (%) at the Month 6 assessment compared with baseline
1. Regression rate at Month 6 assessment, defined as participants who have a decrease in the proportion of cancer or percentage of cancer is not increased but have an increase in non-cancer/non-atypical hyperplasia (%) at the Month 6 assessment compared with baseline
2. Occurrence and severity of adverse events with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
2. Occurrence and severity of adverse events with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
次要结局
- 1. Complete regression rate, defined as the participants who have an assessment of 100% of non-cancer/non-atypical hyperplasia at Month 6 assessment
- 2. Duration of regression, defined as the time from the first regression to time of the first relapse
- 3. Time to regression, defined as the time from the first study treatment to the first regression
- 4. Time to relapse or loss of clinical benefit per investigator, defined as the time from the first study treatment to relapse or loss of clinical benefit per investigator, whichever occurs first. Participants will be censored if they have surgery at Month 6 and no relapse or loss of clinical benefit occurs before surgery
- 5. Plasma concentration of giredestrant at specified timepoints
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG