EUCTR2012-001279-35-BG进行中（未招募）不适用
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.
Ipsen Pharma S.A.S0 个研究点目标入组 120 人开始时间: 2012年10月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •. Histologically proven locally advanced or metastatic prostate
- •cancer who are suitable for androgen deprivation therapy
- •2. Male aged =18 years old
- •3. Screening testosterone level of >125 ng/dL
- •4. Life expectancy of greater than 12 months in the judgement
- •of the Investigator
- •5. Eastern Cooperative Oncology Group (ECOG) performance
- •status of 0-1
- •6. Willing to give signed informed consent freely
- •7. Able to adhere to the study visit schedule and other protocol
- •requirements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 110
排除标准
- •1. Prior hormonal therapy for prostate cancer
- •2. Prior surgery or radiotherapy of prostate cancer with curative
- •intent unless disease is verified by a rising 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
- •3. Presence or history of any other malignancy except for
- •non-melanoma skin cancer adequately treated at least 2 years
- •before study entry
- •4. Painful local bone lesions or spinal lesions which may lead
- •to compression
- •5. 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
- •6. 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
- •7. Abnormal haematological, hepatic or renal functions:
- •Haemoglobin <9 g/dL, absolute neutrophil count =1.5 x 109/L or platelets =100 x 109/L
- •Serum creatinine =1.5 times the upper limit of normal (ULN)
- •Aspartate aminotransferase or alanine aminotransferase >2.5 times the ULN
- •8. Known hypersensitivity to the study treatment, to any of its
- •9. Known active use of recreational drug or alcohol dependence
- •in the opinion of the Investigator
- •10. 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
- •11. Use of systemic corticosteroids (inhaled corticosteroids and
- •topical application of corticosteroids are permitted)
- •12. Aged =90 years for the main study and =80 years for those
- •included in the PK population
- •13. 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
- •14. Any skin or other condition that may preclude s.c. injection
- •administration
- •15. Known brain or epidural metastases.
研究者
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