NCT03261999已完成3 期
An Open-Label, Single-Arm Study of The Efficacy, Safety, and Pharmacokinetic Behavior of Leuprolide Mesylate Injectable Suspension (LMIS 25 mg) in Subjects With Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 21
- 主要终点
- Efficacy of Leuprolide Mesylate (LMIS 25mg)
研究概览
简要总结
The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of subjects with prostate cancer, when administered as two injections twelve weeks apart.
详细描述
This is a multi-national, multi-center, open-label, single-arm study. All subjects will be males with prostate cancer judged to be candidates for medical androgen ablation therapy and all will receive two injections of LMIS 25 mg twelve-week apart in an unblinded fashion.
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
- •Males aged ≥ 18 years old
- •Males with histologically confirmed carcinoma of the prostate
- •Subjects who are judged by the attending physician and/or Principal Investigator to be a candidate for androgen ablation therapy
- •Baseline morning serum testosterone level > 150 ng/dL performed at Screening Visit
- •Eastern Cooperative Oncology Group (ECOG) Performance score ≤ 2
- •Life expectancy of at least 18 months
- •Laboratory values
- •Absolute neutrophil count ≥ 1,500 cells/µL
- •Platelets ≥ 100,000 cells/µL
- •Hemoglobin ≥ 10 gm/dL
- •Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
- •AST (SGOT) ≤ 2.5 × ULN
- •ALT (SGPT) ≤ 2.5 × ULN
- •Serum creatinine ≤ 1.5 mg/dL
- •Lipid profile within acceptable range according to investigator's opinion
- •Serum glucose within acceptable range according to investigator's opinion
- •HgbA1c within acceptable range according to investigator's opinion
- •Clinical chemistries (K, Na, Mg, Ca and P) within acceptable range according to investigator's judgment
- •Serum glucose within acceptable range according to investigator's judgement
- •Urinalysis within normal range according to the investigator's judgment
- •Agree to use male contraceptive methods during study trial
- •Based on the Investigator's judgment, the ability to understand the nature of the study and any hazards of participation, and to communicate satisfactorily with the Investigator and to participate in, and to comply with, the requirements of the entire protocol
- •All aspects of the protocol explained and written informed consent obtained
排除标准
- •Receipt of chemotherapy, immunotherapy, cryotherapy, radiotherapy, or anti- androgen therapy concomitantly, or within 8 weeks prior to Screening Visit, for treatment of carcinoma of the prostate. Radiation for pain control will be allowed during the study.
- •Receipt of any vaccination (including influenza) within 4 weeks of screening visit
- •History of blood donation within 2 months of screening visit
- •History of anaphylaxis to any LH-RH analogues
- •Receipt of any LHRH suppressive therapy within 6 months of screening visit
- •Major surgery, including any prostatic surgery, within 4 weeks of screening visit
- •History and concomitant clinical and radiographic evidence of central nervous system/spinal cord metastases and subjects at risk for spinal cord compression
- •Clinical evidence of active urinary tract obstruction and subjects at risk for urinary obstruction
- •History of bilateral orchiectomy, adrenalectomy, or hypophysectomy
- •History or presence of hypogonadism, or receipt of exogenous testosterone supplementation within 6 months of Baseline
- •Clinically significant abnormal ECG and/or history of clinically significant cardiovascular disease as judged by the investigator
- •History of drug and/or alcohol abuse within 6 months of Baseline
- •Contraindication to leuprolide or an LHRH agonist as indicated on package labeling
- •Use of 5-alpha reductase inhibitor within the last 6 months of screening visit
- •History or presence of insulin-dependent diabetes mellitus (Type I). Presence of well controlled diabetes mellitus Type II will be allowed if only oral hypoglycemic are required. Prostate cancer subjects with poor controlled diabetes mellitus with Hb1Ac > 9.5% or urine glycosuria > 1.0 g/dL should be excluded.
- •Use of systemic corticosteroids at a dose >10 mg/d or anti-androgens
- •Use of any investigational agent within 4 weeks of screening visit
- •Use of any over-the-counter (OTC) medication within 4 weeks of screening visit except for those listed in the permitted Concomitant Treatment section.
- •Uncontrolled intercurrent illness that would jeopardize the subject's safety, interfere with the objectives of the protocol, or limit the subject's compliance with study requirements, as determined by the Investigator in consultation with the Sponsor
研究组 & 干预措施
Leuprolide Mesylate 25mg
Experimental
All subjects will be males with prostate cancer. They will be injected twice with a depot formulation containing 25 mg of Leuprolide Mesylate.
The first dose on day 0 and the second dose on day 84 (twelve weeks apart). Subjects will be followed until day 168.
干预措施: Leuprolide Mesylate (Drug)
结局指标
主要结局
Efficacy of Leuprolide Mesylate (LMIS 25mg)
时间窗: 168 days
The percentage of subjects with a serum testosterone concentration suppressed to castrate levels (≤ 50 ng/dL) from Day 28 through Day 168.
次要结局
- Number of Participants With Adverse Events(168 days)
研究者
研究点 (21)
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相关资讯
FDA Sets PDUFA Date for 3-Month Leuprolide Mesylate in Advanced Prostate Cancer- The FDA has set August 29, 2025, as the PDUFA goal date for Foresee Pharmaceuticals' 3-month formulation of CAMCEVI (leuprolide mesylate) for advanced prostate cancer.
- A phase 3 trial supports the NDA, demonstrating 97.9% of patients achieved and maintained testosterone suppression to castrate levels.
- The 3-month formulation offers an alternative dosing schedule to the currently marketed 6-month version of CAMCEVI.
- Foresee Pharmaceuticals anticipates a successful commercial launch of the 3-month CAMCEVI formulation upon potential FDA approval.last yearForesee Pharmaceuticals Submits NDA for 3-Month Leuprolide Mesylate in Advanced Prostate Cancer- Foresee Pharmaceuticals has submitted an NDA to the FDA for a 3-month depot formulation of leuprolide mesylate (Camcevi) for advanced prostate cancer.
- Phase 3 trial data supports the NDA, demonstrating 97.9% testosterone suppression to ≤50 ng/dL in treated patients.
- The new formulation aims to expand treatment options, offering a ready-to-use profile with potential FDA approval in 2025 and launch in 2026.
- The most common adverse events in the trial included hot flushing, hypertension, increased body weight, and injection site hemorrhage.last yearForesee Pharmaceuticals Seeks FDA Approval for 3-Month Leuprolide Mesylate in Advanced Prostate Cancer- Foresee Pharmaceuticals has submitted an NDA to the FDA for a 3-month depot formulation of leuprolide mesylate (Camcevi) for advanced prostate cancer.
- Phase 3 trial data supports the NDA, demonstrating 97.9% of patients achieved serum testosterone suppression to ≤50 ng/dL by day 28 through day 168.
- The 3-month formulation aims to expand treatment options, complementing the already approved 6-month leuprolide mesylate depot formulation.
- FDA decision is anticipated in 2025, with a potential commercial launch in 2026, offering a ready-to-use profile for patients.last yearForesee Pharmaceuticals Seeks FDA Approval for 3-Month Leuprolide Mesylate in Advanced Prostate Cancer- Foresee Pharmaceuticals has submitted an NDA to the FDA for a 3-month depot formulation of leuprolide mesylate (Camcevi) to treat advanced prostate cancer.
- The NDA is supported by Phase 3 trial data showing 97.9% of patients achieved serum testosterone suppression to castrate levels.
- The 3-month formulation aims to expand treatment options, with potential FDA approval in 2025 and commercial launch in 2026.
- A 6-month formulation of Camcevi is already approved in multiple regions, demonstrating Foresee's commitment to long-acting injectables.last yearFDA Reviews 3-Month Leuprolide Mesylate for Advanced Prostate Cancer- The FDA is reviewing a new drug application for a 3-month depot formulation of leuprolide mesylate for advanced prostate cancer.
- Phase 3 trial data showed 97.9% of patients achieved serum testosterone suppression with the 3-month leuprolide mesylate formulation.
- The treatment demonstrated a manageable safety profile, with common adverse events including hot flushing and hypertension.
- If approved, this ready-to-use formulation could expand treatment options for patients with advanced prostate cancer.last year
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