NCT03081702已完成1 期
A Phase I/II Trial Investigating the Tolerability, Toxicity and Efficacy of Hydroxychloroquine and Itraconazole in Patients With Advanced Platinum-resistant Epithelial Ovarian Cancer (EOC) (HYDRA-1 Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose of hydroxychloroquine
研究概览
简要总结
This is a phase I/II study to find the highest dose of hydroxychloroquine that can be given safely with itraconazole in patients with advanced platinum-resistant epithelial ovarian cancer. The study will also determine the safety, tolerability, and initially determine whether the combination is useful in the treatment of patients with advanced platinum-resistant epithelial ovarian cancer.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older.
- •Histologically or cytologically confirmed epithelial ovarian cancer.
- •Platinum-resistant or refractory disease defined as a radiological or clinical progression less than six months after having finished platinum-based chemotherapy.
- •ECOG performance status equal to or less than
- •Have clinically or radiographically documented measurable disease.
- •All systemic therapy must have been completed 4 weeks or greater prior to enrollment with radiologic evidence of radiological disease progression.
- •Life expectancy should be more than 3 months.
- •Receiving any medications or substances that are inhibitors or inducers of CYP3A4 are ineligible.
- •Acceptable laboratory requirements within 7 days prior to enrollment
- •Treated and asymptomatic brain metastases are eligible. Patients that received palliative radiation (for brain metastases) are eligible if they have been asymptomatic for at least 2 weeks with use of maintenance steroid therapy, and last received radiation at least 4 weeks prior to start of therapy.
- •Have the ability to understand and willing to sign a written informed consent document.
排除标准
- •Have not recovered (grade 1 or less) from adverse events related to previous treatments are excluded with the exception of alopecia and lymphopenia. Peripheral sensory neuropathy must be at grade 2 or less.
- •Have any other prior malignancy from which the patient has been disease free for less than 3 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of any site or any other cancer.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to itraconazole or hydroxychloroquine.
- •Known G6PD deficiency due to the risk of hemolytic anemia with the use of hydroxychloroquine.
- •Known retinopathy due to the risk of worsening retinopathy with hydroxychloroquine.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic or asymptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Chronic Hepatitis B or hepatitis C infections should be excluded because of potential effects on hepatic function and/ or drug interactions.
- •Human Immunodeficiency Virus (HIV) infection.
- •Already have a clinical indication for treatment with itraconazole (e.g. chronic candidiasis or other fungal infection) or hydroxychloroquine (e.g. lupus).
研究组 & 干预措施
Hydroxychloroquine and Itraconazole
Experimental
Hydroxychloroquine, orally (by mouth), at a dose of 100 mg, 200 mg, 400 mg, or 600 mg, twice a day, every day.
Itraconazole, orally (by mouth) at 300 mg, twice a day, every day.
干预措施: Hydroxychloroquine (Drug)
Hydroxychloroquine and Itraconazole
Experimental
Hydroxychloroquine, orally (by mouth), at a dose of 100 mg, 200 mg, 400 mg, or 600 mg, twice a day, every day.
Itraconazole, orally (by mouth) at 300 mg, twice a day, every day.
干预措施: Itraconazole (Drug)
结局指标
主要结局
Maximum tolerated dose of hydroxychloroquine
时间窗: 5 years
Highest dose of hydroxychloroquine that is safe and tolerable that can be given in combination with itraconazole.
次要结局
- Overall response rate(5 years)
- Median progression-free survival(5 years)
研究者
研究点 (1)
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