NCT05856630尚未招募1 期
A Randomized, Open-label, Parallel, Active-controlled Phase 1 Study to Compare Pharmacokinetics Pharmacodynamics and Safety of Goserelin Acetate Sustained-Release Microspheres for Injection (LY01022) With Zoladex® 10.8mg Following Single Administration in Patients With Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Changes in plasma goserelin concentration after administration of LY01022 or Zoladex®
研究概览
简要总结
This is a randomized, open-label, Parallel, active-controlled phase I study. A total of 20-24 patients with locally advanced or metastatic prostate cancer will be randomized in a 1:1 ratio to receive a single injection of LY01022 10.8mg or Zoladex® 10.8mg. Blood samples will be collected to evaluate PK and PD profiles, and safety evaluation will be conducted as required in the protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •18 years or older.
- •Patients with locally advanced or metastatic prostate cancer suitable for endocrine therapy, including those who are suitable for endocrine therapy following radical therapy.
- •Serum testosterone level ≥ 150 ng/dL (1.50 ng/mL or 5.2 nmol/L) at the screening visit.
- •Life expectancy of at least 9 months.
- •ECOG score of ≤
- •Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L, platelet count ≥ 90 x 10^9/L, white blood cell count ≥ 3 x 10^9/L, hemoglobin ≥ 90 g/L.
- •Total bilirubin (TBIL) ≤ 1.5×ULN, ALT and AST ≤ 3×ULN (or ≤ 5.0×ULN for patients with liver metastases).
- •Creatinine clearance ≥50 mL/min at the screening visit.
- •Subjects of childbearing potential must agree to use a reliable method of contraception with their female sexual partners during the study period and at least 6 months after the last administration.
- •Patients who voluntarily sign an IRB-approved informed consent form before any trial-related activities, are willing to abide by the restrictions of the study, and complete the prescribed examinations.
排除标准
- •Patients with prostate cancer who receive previous or ongoing endocrine therapy (surgical castration or other endocrine therapy including GnRH receptor agonists, GnRH receptor antagonists, anti-androgens, estrogens, megestrol acetate, etc.), except for patients with prostate cancer undergoing prostatectomy, radiotherapy or cryotherapy who have received neoadjuvant/adjuvant endocrine therapy for no more than 6 months and discontinued the above therapy more than 6 months before screening.
- •Patients with confirmed or suspected hormone-resistant prostate cancer.
- •Patients who have received prostatic surgery within 4 weeks prior to the first dose, or plan to receive major surgical treatment during the trial.
- •Patients who have previously received hypophysectomy or adrenalectomy, or who have pituitary lesions or adrenal dysfunction.
- •History of severe asthma, anaphylaxis, or severe urticaria and/or angioedema.
- •Other cancer diseases diagnosed within 5 years before the screening visit, except for surgically removed basal or squamous cell carcinoma of the skin.
- •History of the following medical histories within 6 months prior to the screening visit: stroke, transient ischemic attack (TIA), myocardial infarction, unstable angina, coronary revascularization, New York Heart Association (NYHA) class ≥ II cardiac insufficiency, severe unstable arrhythmia.
- •Hypertensive patients with poor blood pressure control (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg at the screening visit).
- •Patients with type 1 diabetes or type 2 diabetes with poor glycemic control (glycosylated hemoglobin > 8% at the screening visit).
- •Patients who have received treatment with 5-α reductase inhibitors (finasteride, dutasteride, enalidomide, epristeride, etc.) within 4 weeks before the first dose.
- •Patients who are receiving coumarin anticoagulants at the screening visit.
- •Have congenital long QT syndrome or QT/QTc interval prolongation (QTc ≥ 450 ms) at the screening visit; Or has received drugs that may prolong QT/QTc interval at the screening visit.
- •Known to be allergic to the active ingredients or any excipients of GnRH agonists or bicalutamide.
- •Patients who are seropositive for hepatitis B surface antigen (HBsAg), and must meet the following 2 conditions at the same time:
- •HBV DNA level: HBeAg-positive patients, HBV DNA ≥ 20,000 IU/ml [equivalent to 10^5 copies/mL]; HBeAg-negative patients, HBV DNA ≥ 2,000 IU/ml [equivalent to 10^4 copies/mL];
- •ALT ≥ 2 x ULN);
- •Patients who are seropositive for HIV antibody or HCV antibody.
- •Alcoholics or drug abusers. Alcoholics are defined as drinking more than 14 units of alcohol per week within 3 months prior to the screening visit (1 unit = 350 mL beer, or 45 mL liquor, or 150 mL wine).
- •Have participated in any clinical trials of investigational drugs or medical devices, and discontinued within 1 month before the screening visit.
- •Other conditions considered unsuitable for enrollment by the investigator (such as spinal cord compression due to prostate cancer metastatic lesions of pyramid, pulmonary interstitial disease or other serious diseases).
研究组 & 干预措施
LY01022
Experimental
干预措施: Goserelin Acetate Sustained-Release Microspheres for Injection (Drug)
Zoladex®
Active Comparator
干预措施: Zoladex 10.8 MG Drug Implant (Drug)
结局指标
主要结局
Changes in plasma goserelin concentration after administration of LY01022 or Zoladex®
时间窗: from baseline to Day 99
次要结局
- Changes in serum luteinizing hormone (LH) concentration after administration of LY01022 or Zoladex®(from baseline to Day 99)
- Changes in serum testosterone concentration after administration of LY01022 or Zoladex®(from baseline to Day 99)
- Adverse events throughout the study(from baseline to Day 99)
- Changes in serum follicle stimulating hormone (FSH) concentration after administration of LY01022 or Zoladex®(from baseline to Day 99)
研究者
研究点 (1)
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