NL-OMON53020已完成2 期
A Randomised, Double-Blind, Placebo-Controlled, Multicentre Phase II Study to Compare the Efficacy, Safety and Tolerability of Olaparib Versus Placebo When Given in Addition to Abiraterone Treatment in Patients With Metastatic Castrate-Resistant Prostate Cancer Who Have Received Prior Chemotherapy Containing Docetaxel - D081DC00008 - Part B
Astra Zeneca0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Provision of signed and dated written informed consent prior to any study
- •specific procedures. 2. Male aged 18 years and older.
- •3. Histologically or cytologically proven diagnosis of prostate cancer.
- •4. Candidate for abiraterone therapy with documented evidence of metastatic
- •castration-resistant prostate cancer. Metastatic status is defined as at least
- •one documented metastatic lesion on either bone scan or CT/MRI scan. Castration
- •resistant prostate cancer is defined as rising PSA or other signs of disease
- •progression despite treatment with androgen deprivation therapy and the
- •presence of a castrate level of testosterone (<=50 ng/dL).
- •5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 with no
- •deterioration over the previous 2 weeks.
- •6. Patients must have a life expectancy >=12 weeks.
- •7. Patients are willing and able to comply with the protocol for the duration
- •of the study including undergoing treatment and scheduled visits and
- •examinations, and completing PRO instruments.
- •8. Patients must be on a stable concomitant medication regimen, defined as no
- •changes in medication or in dose within 2 weeks prior to start of olaparib
- •dosing, except for bisphosphonates, denosumab and corticosteroids, which should
- •be stable for at least 4 weeks prior to start of olaparib dosing.
- •9. For the randomised phase only, patients must have received chemotherapy in
- •the form of docetaxel treatment for metastatic castration-resistant prostate
- •cancer. Note: patients who discontinued docetaxel for toxicity reasons and
- •without completing the full course will still be eligible to enter this study
- •provided they received at least 2 cycles of chemotherapy. Provide informed
- •consent for the pharmacogenetic sampling and analyses.
排除标准
- •1. Involvement in the planning and/or conduct of the study (applies to both
- •AstraZeneca staff, its agents and/or staff at the study site).
- •2. Previous treatment in the present study.
- •3. Treatment with any of the following:- Previous exposure to any 2nd
- •generation anti-hormonal including abiraterone and enzalutamide- More than 2
- •prior courses of chemotherapy for metastatic prostate cancer- Previous use of
- •immunotherapy or radium-223 for the treatment of metastatic prostate cancer-
- •Any investigational agents or study drugs from a previous clinical study within
- •30 days of the first dose of study treatment;- Any previous exposure to a CYP17
- •(17a-hydroxylase/C17,20-lyase) inhibitor;- Substrates of CYP2D6 with a narrow
- •therapeutic index (eg, thioridazine);- Potent inhibitors or inducers of CYP3A4
- •within 2 weeks before the first dose of study treatment (3 weeks for St John*s
- •Wort).- Any previous treatment with a PARP inhibitor, including olaparib.
- •4. With the exception of alopecia or toxicities related to the use of
- •gonadotropinreleasing hormone agonists, any unresolved toxicities from prior
- •therapy greater than CTCAE Grade 2 at the time of starting study treatment.
- •5. Spinal cord compression or brain metastases unless asymptomatic, treated and
- •stable and not requiring steroids for at least 4 weeks prior to start of study
- •6. As judged by the Investigator, any evidence of severe or uncontrolled
- •systemic diseases, including uncontrolled hypertension, active bleeding
- •diatheses, or active infection including hepatitis B, hepatitis C and human
- •immunodeficiency virus (HIV). Screening for chronic conditions is not required.
- •7. Any of the following cardiac criteria:* Mean resting QTc >470 msec
- •obtained from 3 ECGs* Any clinically important abnormalities in rhythm,
- •conduction or morphology of resting ECG eg, complete left bundle branch block,
- •third degree heart block* Any factors that increase the risk of QTc
- •prolongation or risk of arrhythmic events such as heart failure, hypokalaemia,
- •congenital long QT syndrome, family history of long QT syndrome or unexplained
- •sudden death under 40 years of age or any concomitant medication known to
- •prolong the QT interval.
- •8. Other malignancy within the last 5 years except: adequately treated
- •non-melanoma skin cancer or other solid tumours including lymphomas (without
- •bone marrow involvement) curatively treated with no evidence of disease for >=5
- •9. Inadequate bone marrow reserve or organ function as demonstrated by any of
- •the following laboratory values:* Absolute neutrophil count (ANC) <1.5 x
- •109/L* Platelet count <100 x 109/L* Haemoglobin (Hb) <100 g/L* Aspartate
- •aminotransferase (AST) or alanine aminotransferase (ALT)> 2.5 x upper limit
- •of normal (ULN) if no demonstrable liver metastases or> 5 x ULN in the
- •presence of liver metastases* Total bilirubin >1.5 x ULN if no liver
- •metastases or >3 x ULN in the presence of liver metastases (except in the
- •case of Gilbert*s disease)* Creatinine >1.5 x ULN concurrent with creatinine
- •clearance <50 mL/min (measured or calculated by Cockcroft and Gault
- •equation); confirmation of creatinine clearance is only required when
- •creatinine is >1.5 x ULN* If bone metastases are present and liver function
- •is otherwise considered adequate by the Inves
研究者
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