IIT2021-09-Posadas-NA-TAZ: A Study of Tazemetostat (Tazverik) Before Prostatectomy in Men With Prostate Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Proportion of patients able to undergo surgery
研究概览
简要总结
This study is an open-label, single-arm, pilot, perioperative study of EZH2 inhibition in patients undergoing Radical Prostatectomy (RP). The EZH2 inhibition is intended to increase the sensitivity of the underlying tumor to the patient's immune system.
Given the absence of data in this setting, we propose to pilot this experience with 4 weeks of tazemetostat at doses known to be clinically safe and effective at inducing clinical effects via inhibition of EZH2 as established for follicular lymphoma and epithelioid sarcoma: 800 mg twice daily with or without food.
Prior to tazemetostat, blood will be collected (4 tubes) for immune cells, Circulating Tumor Cells, and plasma. This will be repeated at the time of RP. RP tissues will be collected.
Additionally, patients will have a week lead-in to wear a FitBit Charge 5TM device (or similar model) to continuously monitor physical activity from baseline up until end of study. The start of the week lead-in will be considered the baseline visit. Subjects will also be asked to continue wearing the device until end of study and option to continue for up to 2 years after end of study in follow-up.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men electing to undergo radical prostatectomy with preoperative tissue available
- •Able to take oral medications
- •Age ≥18 years
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- •Adequate organ function
- •Men with partners of childbearing potential, must have had a successful vasectomy (with medically confirmed lack of sperm that are alive) OR must either practice complete abstinence or agree to use adequate contraception
- •Inclusion criteria for remote monitoring component of study with Fitbit only (failure to meet inclusion criterion for Fitbit-monitoring portion of study should not preclude participating in treatment trial): Access to a device (e.g., smart phone, tablet) that has the capability to sync to the Fitbit. Note: access can be via family member, friend, caregiver, or study-designated device provided by study member
排除标准
- •Active intercurrent illness or malignancy requiring therapy outside of prostate cancer
- •History of bleeding disorders
- •Concurrent use of anti-platelet agents or therapeutic anticoagulants with the exception of low-dose aspirin (81 mg daily) or NSAIDs for pain/inflammation.
- •Concurrent use of strong and moderate CYP3A inhibitors and inducers
- •Subjects who have previously received tazemetostat
- •Currently participating in a study using an investigational, medicinal anti-cancer agent within 4 weeks prior to first dose of tazemetostat
- •Exclusion criteria for remote monitoring component of study with Fitbit only (failure to meet exclusion criterion for Fitbit-monitoring portion of study should not preclude participating in treatment trial): Using a pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implants (removable hearing aids permitted), or other electronic medical equipment, per PI's discretion.
研究组 & 干预措施
Tazemetostat
Tazemetostat 200 mg oral tablets; 800 mg by mouth twice daily for 28 days
干预措施: Tazverik (Drug)
结局指标
主要结局
Proportion of patients able to undergo surgery
时间窗: At time of surgery
Proportion of patients with evaluable tissue specimens following tazemetostat
时间窗: At time of surgery
Incidence of adverse events, serious adverse events, and treatment-related adverse events.
时间窗: From start of study treatment until confirmation of disease progression, intolerable toxicities, or withdrawal of consent, whichever came first. Assessed up to 30 days following last dose of study treatment.
Evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Proportion of patients with Grade 3 or above treatment related adverse events
时间窗: From start of study treatment until confirmation of disease progression, intolerable toxicities, or withdrawal of consent, whichever came first. Assessed up to 30 days following last dose of study treatment.
Grade 3 or above treatment related adverse events as assessed per NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
次要结局
- Clinical Progression Free Survival(From the start of study treatment until documented progression, or death due to any cause. Assessed up to 5 years.)
研究者
Edwin Posadas, MD
Co-Director, Experimental Therapeutics Program
Cedars-Sinai Medical Center