EUCTR2013-004091-34-GB进行中（未招募）不适用
A randomised Phase II study of Enzalutamide (MDV3100) in combination with AZD5363 in Patients with Metastatic Castration - Resistant Prostate Cancer - RE-AKT
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 136
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
- •1)Written informed consent.
- •2)Histological diagnosis of adenocarcinoma of the prostate and with archival tumour tissue
- •3)Metastatic Castration-Resistant Prostate Cancer (mCRPC).
- •4)Progressed after 1 or 2 lines of taxane based chemotherapy.
- •5)Progressed after at least 12 weeks of abiraterone
- •6)Age 18 years or above.
- •7)Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
- •8)PSA greater than or equal to 10ng/ml.
- •9)Documented willingness to use an effective means of contraception while participating in the study and for 12 months post last dose of treatment
- •10)Documented ongoing castrate serum testosterone <50 ng/dL (<2.0 nM).
- •11)Received prior castration by orchiectomy and/or ongoing Luteinizing Hormone-Releasing Hormone (LH-RH) agonist treatment.
- •12)Progression of disease by PSA utilizing PCWG2 criteria and at least another of the following criteria;
- •a.disease progression as defined by at least 2 new lesions on bone scan.
- •b.Soft tissue disease progression defined by modified RECIST 1.1.
- •c.Clinical progression (worsening pain & the need for palliative radiotherapy).
- •PHASE I SAFETY RUN IN and EXPANSION COHORT - inclusion criteria:
- •13)Willing to have a biopsy to obtain tumour tissue for biomarker analyses prior to and after treatment.
- •SINGLE STAGE PHASE II EXPANSION COHORT ONLY - inclusion criteria:
- •14)Prior exposure to enzalutamide of at least 12 weeks is required with documented disease progression
- •15)Archival tumour tissue available for the analysis of PTEN loss by the central laboratory
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 48
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •1)Prior treatment with enzalutamide (not applicable for the phase I safety run in or for the single stage phase II expansion cohort).
- •2)Prior treatment with PI3K, AKT, TOR kinase or mTOR inhibitors
- •3)Surgery, chemotherapy, or other anti-cancer therapy within 4 weeks prior to trial entry / randomisation into the study (6 weeks for bicalutamide). Any other therapies for prostate cancer, other than GnRH analogue therapy, such as progesterone, medroxyprogesterone, progestins (megesterol), or 5-alpha reductase inhibitors (e.g., finasteride or dutasteride), must be discontinued at least 2 weeks before the first dose of study drug.
- •4)Participation in another clinical trial and any concurrent treatment with any investigational drug within 4 weeks prior to trial entry / randomisation.
- •5)Prior limited field radiotherapy within 2 weeks or wide field radiotherapy within 4 weeks of trial entry / randomisation.
- •6)History of seizure or any condition that may predispose to seizure including, but not limited to underlying brain injury, stroke, primary brain tumours, brain metastases, or alcoholism.
- •7)History of loss of consciousness or transient ischemic attack within the previous 12 months of trial entry / randomisation.
- •8)Known brain or leptomeningeal involvement.
- •9)Use of potent inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19 within 2 weeks before trial entry / randomisation (3 weeks for St John¡¯s Wort) must be avoided.
- •10)Clinically significant abnormalities of glucose metabolism as defined by any of the following:
- •a.Diagnosis of diabetes mellitus type I or II
- •b.Glycosylated haemoglobin (HbA1C) =8.0% at screening
- •c.Fasting Plasma Glucose =8.9mmol/L at screening.
- •11)Inadequate organ and bone marrow function as evidenced by:
- •a.Haemoglobin <8.5 g/dL
- •b.Absolute neutrophil count <1.0 x 109/L
- •c.Platelet count < 75 x 109/L
- •d.Albumin =25 g/dL.
- •e.AST / SGOT and/or ALT / SGPT = 2.5 x ULN (=5 x ULN if liver metastases)
- •f.Total bilirubin = 1.5 x ULN (except for patient with Gilbert's disease)
- •g.Serum Creatinine > 1.5 x ULN
- •12)Inability or unwillingness to swallow oral medication.
- •13)Malabsorption syndrome or other condition that would interfere with enteral absorption.
- •14)Any of the following cardiac criteria;
- •a.Mean resting corrected QT interval (QTcF) >470msec obtained triplicate ECGs
- •b.Clinically important abnormalities(rhythm/conduction/morphology)resting ECG
- •c.Factors that increase risk of QTc prolongation or risk of arrhythmic events
- •d.Experience of any of the following in the preceding six months:
- •- coronary artery bypass graft
- •- angioplasty
- •- vascular stent
- •- myocardial infarction
- •- angina pectoris
- •- congestive heart failure NYHA = Grade2
- •e.Uncontrolled hypotension
- •15)Clinically significant history of liver disease consistent with Child-Pugh Class B or C, including viral or other hepatitis, current alcohol abuse, or cirrhosis.
- •16)Any other finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patients at high risk from treatment complications.
- •17)Need for chronic corticosteroid therapy of >10 mg of prednisolone or >0.5mg of dexamethasone per day or an equivalent dose of other anti inflammatory corticosteroid.
- •18)Malignancies other than prostate cancer within 5 years prior to trial ent
研究者
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