PER-006-19尚未招募未知
PARALLEL GROUP SINGLE BLIND STUDY TO COMPARE THE PHARMACOKINETIC PROFILES AND PHARMACODYNAMIC RESPONSE OF A NEW DEPOT FORMULATION OF GOSERELIN ACETATE CAPSULE/IMPLANT FOR SUBCUTANEOUS INJECTION, PEPTI 10.8 MG, TO ZOLADEX 10.8 MG CAPSULE/IMPLANT IN AMBULATORY PATIENTS WITH ADVANCED CARCINOMA OF THE PROSTATE.
PEPTIGROUPE Inc,0 个研究点目标入组 0 人开始时间: 2019年6月17日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1Be a male ≥ 18 years of age
- •2Be an ambulatory patient with advanced carcinoma of the prostate, as verified by an available previous biopsy
- •3Have a life expectancy ≥ 1 year
- •4Have a testosterone level ˃ 5 nmol/L or ˃ 1.5 ng/mL at screening
- •5Have the ability to understand the requirements of the study and is willing to provide written informed consent
- •6Agree to abide by the study restrictions and return for the required assessments
排除标准
- •1.Have brain metastases
- •2.Have vertebral metastases with evidence of spinal cord compression
- •3.Have renal impairment due to ureteric obstruction or a recent history of obstructive uropathy
- •4.Have excruciating, severe bone pain due to extensive bone metastases. Concomitant therapy with either flutamide or bicalutamide is permitted during the first month of the study, in the case where bone metastases are present or suspected
- •5.Have undergone orchiectomy, adrenalectomy or hypophysectomy
- •6.Have undergone prostatic surgical procedures (e.g., radical prostatectomy, transurethral resection of the prostate) within the last month
- •7.Have undergone localized external beam radiotherapy, brachytherapy, thermotherapy, cryotherapy within the last 4 weeks
- •8.Have undergone systemic chemotherapy, immunotherapy (e.g., antibody therapies, tumor-vaccines) or biological response modifiers (e.g., cytokines) within the last 3 months
- •9.Have been treated with 5-alpha-reductase inhibitors (e.g., finasteride (Proscar®, Propecia® ) dutasteride (Avodart®)) within the last 3 months
- •10.Have been previously treated with luteinizing hormone releasing hormone agonists (LHRHa) (e.g., leuprolide (Lupron®), goserelin (Zoladex) etc.) in the past 6 months.
- •11.Have an ongoing treatment with androgen receptor (AR) blockers (e.g megestrol (Megace®) cyproterone (Androcur®). (For the mitigation of the initial testosterone flare, Bicalutamide (Casodex®) treatment is permitted, but must be initiated prior to study and terminated at the latest 30 days after the patient has received goserelin depot injection).
- •12.Have a known hypersensitivity to gonadotropin releasing hormone (GnRH), GnRH agonists, any LHRH agonists (e.g., leuprolide (Lupron®), goserelin (Zoladex) etc.) or to the PLGA polymers contained in the study formulation
- •13.Have a severe liver disease (e.g., cirrhosis, chronic active hepatitis or chronic persistent hepatitis) or have persistent ALT, AST ˃ 2 X ULN, serum creatinine ˃ 2 X ULN, serum bilirubin ˃ 2 X ULN
- •14.Have received an investigational drug or participated in a clinical trial within the last 30 days
- •15.Have a clinically serious and/or unstable concurrent infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Investigator, may be jeopardized by participation in this study or by the complications of this therapy
- •16.Have a BMI<18.5
- •17.Have an INR≥2
- •18.Have a history of QT prolongation, congenital long QT syndrome, electrolyte abnormalities, CHF, or concurrent administration with QT prolonging drugs or QTc>450 msec.
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