NCT05647447撤回早期 1 期
Pilot of Osanetant to Reduce Severity of Hot Flashes in Men With Adenocarcinoma of the Prostate (POSH-MAP)
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- To evaluate the preliminary efficacy of in reducing the frequency and severity of vasomotor symptoms (VMS) in men on androgen deprivation therapy (ADT).
研究概览
简要总结
To evaluate the preliminary efficacy of in reducing the frequency and severity of hot flashes in men on androgen deprivation therapy (ADT).
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
- •Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
- •Males ≥ 18 years
- •Histologic diagnosis of prostate cancer (PCa)
- •Undergoing active treatment with ADT within ≥ 30 days prior to randomization
- •Using either an gonadotropin releasing hormone (GNRH) agonist with a planned duration covering the 8 weeks of the study or are status post bilateral orchiectomy,
- •Have a castrate level of testosterone (≤ 50 ng/dL) at enrollment
- •Have moderate-to-severe hot flashes defined as
- •Seven (7) or more hot flashes per day
- •Total hot flash severity (HFS: total number of hot flashes for 1 week multiplied by the average severity/week) ≥ 100
- •Adequate organ function, defined as follows: Result Date
- •Leukocytes > 1.5K/UL
- •Absolute Neutrophil Count (ANC) >1.5K/UL NOTE: Patients with established diagnosis of benign neutropenia are eligible to participate with ANC between 1000-1500 if in the opinion of treating physician the trial treatment does not pose excessive risk of infection to the patient.
- •Platelets >100K/UL
- •Hemoglobin ≥ 9 g/dL
- •Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault equation
- •Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault equation
- •Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ 1 x ULN
- •Aspartate aminotransferase and alanine aminotransferase ≤ 1.5 x ULN
- •Women of child-bearing potential and men with partners of childbearing potential must agree to practice sexual abstinence or to use the forms of contraception listed in Child-Bearing Potential/Pregnancy section for the duration of study participation and for 30 days following completion of therapy.
排除标准
- •Concurrent invasive malignancy or invasive malignancy within 2 years except for chronic lymphocytic leukemia/small lymphocytic lymphoma on surveillance, suspected or proven clinical stage 1 (cT1) renal cell carcinoma on active surveillance, or the following malignancies treated with curative intent via surgical resection: carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, low-grade non-muscle-invasive urothelial carcinoma, non-melanoma skin cancer.
- •Simultaneously enrolled in any therapeutic clinical trial
- •Current or anticipating use of other pharmacologic anti-neoplastic (including hormonal), or investigational agents while participating in this study. Concurrent treatment with radiotherapy is permitted.
- •Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
- •Has a known allergic reaction to any excipient contained in the study drug formulation
- •Active Grade 3 (per the NCI CTCAE, Version 5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment.
- •Participants using the following medications within 2 weeks prior to first dosing (or within 5 times the half-life of that medication, whichever is longer) will be excluded from the study:
- •Inhibitors of CYP3A4 (including but not limited to macrolide antibiotics, HIV protease inhibitor, azole antifungal drugs, cyclosporine, calcium channel inhibitor, cimetidine)
- •Inducers of CYP3A4 (including but not limited to rifampicin, carbamazepine, efavirenz, bosentan, modafinil, St. John's Wort), Medications with narrow therapeutic index that are metabolized CYP3A4 and/or CYP2D6 are not allowed from screening until up to 5 half-lives after last dose of Osanetant is administered.
研究组 & 干预措施
Pilot Trial: Osanetant 28 Days
Experimental
Osanetant 200 mg orally, twice per day for 28 days.
干预措施: Osanetant (Drug)
结局指标
主要结局
To evaluate the preliminary efficacy of in reducing the frequency and severity of vasomotor symptoms (VMS) in men on androgen deprivation therapy (ADT).
时间窗: 28 days
Efficacy will be assessed using a composite outcome of median weekly hot flash frequency and severity at week 4 compared to baseline.
次要结局
- To evaluate the effect of Osanetant on follicle stimulating hormone for men with prostate cancer on ADT.(28 days)
- To evaluate the effect of Osanetant on luteinizing hormone for men with prostate cancer on ADT.(28 days)
- To evaluate the effect of Osanetant on testosterone for men with prostate cancer on ADT.(28 days)
- To evaluate the effect of Osanetant on estradiol for men with prostate cancer on ADT.(28 days)
- Functional Assessment of Cancer Therapy-Prostate (FACT-P)(28 days)
- EuroQOL 5-dimension(28 days)
- Patient Health Questionnaire-9 question (PHQ-9).(28 days)
- General Anxiety Disorder-7 question (GAD-7)(28 days)
- Hot Flash Related Daily Interference Scale (HFRDIS).(28 days)
研究者
研究点 (1)
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