A Phase II Study of Enzalutamide (NSC# 766085) for Patients With Androgen Receptor Positive Salivary Cancers
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 46
- 试验地点
- 287
- 主要终点
- Best Overall Response Rate
研究概览
简要总结
This study will test any good and bad effects of the study drug called enzalutamide. Enzalutamide could shrink the cancer but it could also cause side effects. Researchers hope to learn if the study drug will shrink the cancer by at least 30% compared to its present size, in at least 1 out of 5 patients. Enzalutamide is not FDA approved to treat salivary gland cancer, but it has already been FDA-approved to treat other cancers.
详细描述
This single arm Phase II trial will assess the best overall response associated with enzalutamide in patients with AR-positive salivary cancers. Given that this will be one of the first prospective studies ever conducted for AR-positive salivary cancers, and there are currently no standard therapies known to be effective for this disease, the investigators will adopt a best overall response (BOR) of 5% as the null hypothesis and BOR of 20 % as the alternative hypothesis. In addition to response, this study will also evaluate the progression-free survival (PFS), overall survival (OS), adverse events, and will also try to identify molecular predictors of response by examining genomic and transcriptional elements of androgen receptor biology.
The primary and secondary objectives of the study:
Primary objective
To evaluate the rate of best overall response associated with enzalutamide in patients with AR-positive salivary cancers
Secondary objectives
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
- All
- 接受健康志愿者
- 否
入选标准
- •Documentation of Disease - Histologic Documentation: Histologically proven diagnosis of salivary cancer by central pathology review. Receptor status: AR expression detected by immunohistochemistry by central review.
- •Disease status - Measurable disease as defined in the protocol. Locally advanced/unresectable (as determined by local surgeon) OR metastatic disease.
- •Prior Treatment
- •Any number of prior lines of therapy
- •No treatment with biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation ≤ 28 days before study registration. No treatment with nitrosourea or mitomycin ≤ 42 days before study registration
- •No prior therapy with enzalutamide (previous chemotherapy and/or other AR-targeted approaches is allowed).
- •Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. A female of childbearing potent is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (ie, has had menses at any time in the preceding 12 consecutive months). For women of childbearing potential only, a negative pregnancy test done ≤ 5 days prior to registration is required.
- •Age ≥ 18 years
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- •No History of the following:
- •prior brain metastases
- •leptomeningeal disease
- •class 3 or 4 congestive heart failure
- •uncontrolled hypertension (systolic BP > 170 mmHg or diastolic BP > 105 mmHg)
- •major surgery ≤ 4 weeks of registration
- •Required Initial Laboratory Values:
- •Absolute Neutrophil Count (ANC) ≥ 1,500/mm3
- •Platelet Count ≥ 100,000/mm3
- •Creatinine ≤ 1.5 x ULN Upper Limit of Normal (ULN) OR
- •Calculated Creatinine Clearance ≥ 30 mL/min
- •Total Bilirubin ≤ 1.5 x ULN
- •AST/ALT ≤ 3.0 x ULN
- •Concomitant medications- Chronic concomitant treatment with strong CYP2C8 inhibitors is not allowed. Patients must discontinue the drug ≥ 14 days prior to registration. Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug ≥ 14 days prior to registration.
排除标准
- 未提供
研究组 & 干预措施
Enzalutamide
Patients receive 160 mg enzalutamide orally once daily (1 cycle=28 days). Patients will remain on therapy until progression of disease or development of unacceptable toxicities or patient or physician withdrawal. Patients will undergo radiographic imaging every 2 months while on study treatment in order to determine response.
干预措施: enzalutamide (Drug)
结局指标
主要结局
Best Overall Response Rate
时间窗: Up to 32 weeks
The best overall response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients.
次要结局
- Number of Patients Experiencing at Least One Grade 3+ Adverse Event Using CTCAE Version 4.0(30 days post-treatment, up to 32 months)
- Progression-free Survival(Up to 32 months post study enrollment)