Open-label, Safety Extension Study for Subjects With HR+, HER2-Negative Breast Cancer Who Have Completed the OVarian Suppression Evaluating Subcutaneous LeuprolIde Acetate in Breast Cancer OVELIA Study

Tolmar Inc.50 个研究点分布在 6 个国家目标入组 250 人开始时间: 2022年12月28日最近更新: 2026年9月1日

适应症

干预措施

试验速览

阶段: 3 期
状态: Enrolling By Invitation
发起方: Tolmar Inc.
入组人数: 250
试验地点: 50
主要终点: The occurrences of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

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

TOL2506A (OVELIA) is a Phase 3, single arm, open-label study evaluating the effectiveness of TOL2506 in suppressing ovarian function in premenopausal women with HR+, HER2-negative breast cancer and men with HR+ breast cancer. The TOL2506A-EXT study described here is a safety extension study to assess and collect long-term data on the ongoing safety and tolerability of TOL2506 in combination with tamoxifen or an AI for up to 4 years.

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: 18 Years 至 51 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•Completed Visit 9, Week 48 visit of TOL2506A study and is a candidate for continued endocrine therapy + ovarian suppression
•Able to understand the investigational nature of this study and provide written informed consent prior to the participation in the trial
•Age 18 to 51 inclusive

排除标准

•Body mass index (BMI) < 18.00 kg/m2
•Life expectancy < 12 months
•ECOG performance status ≥ 3
•Unacceptable hepatic function as determined by any of the following:
•Alanine aminotransferase (ALT) ≥ 2X upper limit of normal (ULN)
•Aspartate aminotransferase (AST) ≥ 2X ULN
•Bilirubin ≥ 2X ULN
•Alkaline phosphatase ≥ 2X ULN
•Severe hepatic impairment (Child-Pugh Class C)
•Unacceptable renal function as determined by any of the following:
•Creatinine ≥ 3X ULN
•Creatinine clearance ≤ 30 mL/minute
•Creatinine clearance ≤ 60 mL/minute in subjects with bone density 1.5 standard deviations below the young adult normal mean
•Screening 12-lead ECG demonstrating any of the following:
•Heart rate > 100 beats per minute (BPM)
•QRS > 120 msec
•Corrected QT (QTc) > 450 msec
•PR > 220 msec
•Use of any new medications known to prolong the QT/QTc interval
•Any new medical condition or psychiatric, addictive or other disorder that, in the opinion of the Investigator, may interfere with trial conduct or result in the subject being ineligible to continue treatment with TOL2506
•Concomitant use of medications that may impact subject safety including but not limited to:
•Oral or transdermal hormonal therapy
•Estrogen, progesterone, or androgens
•Hormonal contraceptives
•Change in tolerability to TOL2506 that precludes continued treatment
•Sexually active with a male partner and not willing to use at least 2 non-hormonal contraceptive methods throughout the study
•Is of childbearing potential with a positive urine pregnancy test at Screening
•Inclusion Criteria:
•Completed Visit 9, Week 48 visit of TOL2506A study and is a candidate for continued endocrine + GnRH agonist therapy
•Able to understand the investigational nature of this study and provide written informed consent prior to participation in the trial
•Exclusion Criteria:
•BMI < 18.00 kg/m2
•Life expectancy < 12 months
•ECOG performance status ≥ 3
•Unacceptable hepatic function as determined by any of the following:
•ALT ≥ 2X ULN
•AST ≥ 2X ULN
•Bilirubin ≥ 2X ULN
•Alkaline phosphatase ≥ 2X ULN
•Severe hepatic impairment (Child-Pugh Class C)
•Unacceptable renal function as determined by any of the following:
•Creatinine ≥ 3X ULN
•Creatinine clearance ≤ 30 mL/minute
•Creatinine clearance ≤ 60 mL/minute in subjects with bone density 1.5 standard deviations below the young adult normal mean
•Screening 12-lead ECG demonstrating any of the following:
•HR > 100 BPM
•QRS > 120 msec
•QTc > 450 msec
•PR > 220 msec
•Use of any new medications known to prolong the QT/QTc interval
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