NCT01715129已完成3 期
A Phase III Single Arm Study to Evaluate the Efficacy, Safety and Local Tolerability of a Subcutaneous 3-month Formulation of Triptorelin Pamoate (11.25 mg) in Patients With Locally Advanced or Metastatic 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
- 发起方
- Ipsen
- 入组人数
- 126
- 主要终点
- Percentage of Subjects Demonstrating Castration at Day 29 and Maintaining Castration at Day 183
研究概览
简要总结
Assess the efficacy and safety of Triptorelin pamoate 3M formulation (11.25mg) when administered by subcutaneous route.
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
- •Histologically proven locally advanced or metastatic prostate cancer who are suitable for androgen deprivation therapy
- •Male aged ≥18 years old
- •Screening testosterone level of >125 ng/dL
- •Life expectancy of greater than 12 months in the judgement of the Investigator
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •Willing to give signed informed consent freely
- •Able to adhere to the study visit schedule and other protocol requirements.
排除标准
- •Prior hormonal therapy for prostate cancer
- •Prior surgery or radiotherapy of prostate cancer with curative intent unless disease is verified by a rising prostate specific antigen (PSA) concentration on follow up (elevated PSA values on last two tests conducted at least a month apart) and the patient is eligible for androgen deprivation therapy
- •Presence or history of any other malignancy except for non melanoma skin cancer adequately treated at least 2 years before study entry
- •Painful local bone lesions or spinal lesions which may lead to compression
- •History of myocardial infarction, percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass graft, Class III/IV congestive heart failure, cerebrovascular accident, transient ischaemic attack, or limb claudication at rest, within six months prior to start of study treatment and ongoing symptomatic dysrhythmias, unstable angina, uncontrolled hypertension, and untreated atrial or uncontrolled ventricular arrhythmias
- •Any condition in opinion of the Investigator, including other active or latent infections, medical or psychiatric conditions, or the presence of laboratory abnormalities, which could confound the ability to interpret data from the study, compromises the objective of the study or places the patient at unacceptable risk if he participates in the study
- •Abnormal haematological, hepatic or renal functions:
- •Haemoglobin <9 g/dL, absolute neutrophil count ≤1.5 x 10^9/L or platelets ≤100 x 10^9/L
- •Serum creatinine ≥1.5 times the upper limit of normal (ULN)
- •Aspartate aminotransferase or alanine aminotransferase >2.5 times the ULN
- •Known hypersensitivity to the study treatment, to any of its excipients
- •Known active use of recreational drug or alcohol dependence in the opinion of the Investigator
- •Any current use or use within six months prior to start of treatment, of medications which are known to affect the metabolism and/or secretion of androgenic hormones: e.g. ketoconazole, aminoglutethimide, oestrogens, and progesterone
- •Use of systemic corticosteroids (inhaled corticosteroids and topical application of corticosteroids are permitted)
- •Aged ≥90 years for the main study and ≥80 years for those included in the pharmacokinetic (PK) patient population
- •Participation in any other study or receipt of any investigational compound in the 30 days (or five times the elimination half life if this is longer) prior to study entry
- •Any skin or other condition that may preclude s.c. injection administration
- •Known brain or epidural metastases.
研究组 & 干预措施
11.25mg
Experimental
11.25mg, SC on Day 1 and Day 92
干预措施: Triptorelin Pamoate 11.25mg (Drug)
结局指标
主要结局
Percentage of Subjects Demonstrating Castration at Day 29 and Maintaining Castration at Day 183
时间窗: At Day 29 and 183
Percentage of subjects castrated (i.e. with serum testosterone \<50 ng/dL or 1.735 nmol/L, using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and the proportion with castration maintained at Day 183 (after receiving 2 S.C. administrations of triptorelin pamoate, three months apart); they were calculated along with their respective 95% confidence intervals (CI) using exact methods on the ITT population at Day 29 and on the initially castrated (IC) population at Day 183
次要结局
- Percentage of Subjects Demonstrating Castration Before Administration of the Second Dose(At Day 92)
- Probability of Testosterone <50 ng/dL(Day 29 through Day 183)
- Cmin of Triptorelin in Subset of 18 Subjects(At Day 92 and 183)
- Percentage of Subjects With Normal and Abnormal PSA Levels at Day 183 (End of Study Visit)(At Day 183)
- Percentage of Subjects With Adverse Events(Up to Day 183)
- Time to Cmax (Tmax) of Triptorelin(At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1)
- Percentage of Subjects Demonstrating Castration With Testosterone Level <50 ng/dL at Day 95(Day 95)
- Percentage Change in Prostate Specific Antigen (PSA) Levels From Baseline in All Subjects(From Day 1 (Baseline) to Day 183 (End of study))
- Peak Plasma Concentration Value (Cmax) of Triptorelin(At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1)
- Area Under the Concentration Versus Time Curve Between 0 and 24 Hours (AUC0-24) of Triptorelin(At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1)
- Time to Achieve Castration (Tcast)(Up to Day 36)
- Plasma Triptorelin Levels (Cmin)(At Day 92 and 183)
- Clinically Apparent Tumor Progression(Day 92 and 183)
研究者
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