EUCTR2016-000869-23-GB进行中（未招募）1 期
Targeting cancer care with the use of genetic profiling - BARCODE 2
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •For Part 1 (genetic screening) of the study:
- •1.Age = 18 years.
- •2.Histologically confirmed prostate adenocarcinoma. A copy of the original histology report from biopsy or surgery must be obtained.
- •3.Castration-resistant disease defined as biochemical or radiological progression on/after treatment with orchidectomy or LHRH analogues as per PCWG2 criteria.
- •4.Confirmed metastatic disease on conventional imaging methods such as CT, bone scan or PET imaging.
- •5.Current or previous treatment including docetaxel and/or enzalutamide/ abiraterone
- •6.Adequate renal function measured by calculated GFR (Cockcroft-Gault) >30ml/min. This must be documented within 7 days of registration. If a patient had renal dysfunction that is expected to improve, they may be considered for part 1 of the study
- •7.Adequate haematological function (haemoglobin =10g/dl, neutrophil count >1.5x109/L and platelets >100x109/L). This must be documented within 7 days of registration.
- •8.WHO performance status 0-2 as assessed and documented by study doctor.
- •9.Life expectancy >12 weeks
- •10.Patients with stable, treated brain metastases will be eligible providing informed consent can be given and that other sites of measurable disease are present
- •11.The subject is capable of understanding and complying with the protocol requirements and has signed the BARCODE 2 informed consent form.
- •In addition to the above, for Part 2 of the study:
- •1.Confirmed pathogenic germline mutation in a DNA repair gene. (Patients with a known germline mutation will need to provide a report from the external laboratory where genetic testing was carried out)
- •2.Previous treatment with docetaxel and abiraterone or enzalutamide with documented disease progression prior to study entry to part 2 (rising PSA and/or radiographic progression)
- •3.Adequate liver function: Total bilirubin =1.5 x upper limit of normal (ULN) except for patients with known Gilbert’s syndrome; AST and ALT = 2.5x ULN in the presence of liver metastases.
- •4.Adequate renal function: creatinine clearance >40ml/min measured by EDTA clearance.
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14
排除标准
- •Exclusion Criteria (for part 1 and 2)
- •1.Critical organ metastases (e.g. spinal metastases with risk of cord compression) as documented on most recent imaging report.
- •2.Patients with bleeding tumours.
- •3.Previous treatment with a platinum chemotherapy drug for prostate cancer.
- •4.Previous treatment with a PARP inhibitor
- •5.Patients with a history of severe allergic to carboplatin or other platinum-containing compounds
- •6.Patients unfit for chemotherapy or those with ongoing neuropathy >grade 1 (sensory or motor) according to NCI CTCAE V4.02.
- •7.Known and documented hearing impairment
- •8.Other active malignancies or previous malignancies likely, in the PI’s opinion, to impact on management of mCRPC.
- •9.Significant documented cardiovascular disease: severe/unstable angina, myocardial infarction less than 6 months prior to trial entry, arterial thrombotic events less than 6 months prior to trial entry, clinically significant cardiac failure requiring treatment (NYHA II-IV).
- •10.Cerebrovascular disease (CVA or TIA) in the preceding 2 years to entry to Part 2 of study.
- •11.Presence of symptomatic brain metastases.
研究者
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