EUCTR2019-003485-40-GB进行中（未招募）1 期
ACTION: Phase I/II Trial of Abiraterone Acetate in Combination with Tildrakizumab (anti-IL23 targeting monoclonal antibody) in Men with Metastatic Castration-Resistant Prostate Cancer (mCRPC) - ACTION: Abiraterone in Combination with Tildrakizumab
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 45
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 and be capable of cooperating with treatment & follow up.
- •2.Age = 18 years
- •3.Histologically or cytologically proven adenocarcinoma of the prostate.
- •4.Metastatic castration resistant prostate cancer.
- •5.Documented prostate cancer progression as assessed by the investigator with one of the following:
- •a. Progression of soft tissue/visceral disease by RECIST (v1.1) and/or,
- •b. Progression of bone disease by PCWG3 bone scan criteria and/or,
- •c. Progression of PSA by PCWG3 PSA criteria and/or,
- •d. Clinical progression with worsening pain and need for palliative radiotherapy for bone metastases.
- •6.Patients may have received have progressed after either enzalutamide or abiraterone treatment (having received a minimum of 12 weeks enzalutamide or abiraterone).
- •7.Ongoing androgen deprivation maintaining serum testosterone of less than 50 ng/dL (less than 2.0 nM) is mandatory.
- •8.Life expectancy of at least 12-weeks.
- •9.World Health Organisation (WHO) performance status of 0-2.
- •10. Able to swallow the study drug
- •11.Archival tissue must be available for research analysis
- •12.Patients must have disease that is amenable to biopsy and must be willing to undergo tumour biopsies.
- •13.Subjects must either have measurable disease as according to RECIST v1.1 or if the patient has bone-only metastases, a CTC count of = 5/7.5 ml blood.
- •14. Haematological and biochemical indices within the ranges shown in 4.1.1 of the protocol. These measurements must be performed within one week of starting IMP
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years)
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Patients with predominantly small cell or neuroendocrine differentiated prostate cancer
- •2.Prior therapy, including major surgery, chemotherapy, radium-223 or other anti-cancer therapy within 4 weeks prior to IMP administration. The use of bisphosphonates or RANK ligand inhibitors in patients with known osteopenia or osteoporosis or bone metastases is permitted. A single fraction of palliative radiation is permitted if at least 14-days before starting trial treatment.
- •3. Prior hormonal treatment
- •4.Prior limited field radiotherapy within the previous 2 weeks or wide field radiotherapy within the previous 4 weeks prior to IMP administration
- •5.Participation in another interventional clinical trial & any concurrent treatment with any investigational drug within 4 weeks prior to IMP
- •6.Any toxicities due to prior chemotherapy &/or radiotherapy that have not resolved to a NCI-CTCAE v4.02 Gr. =1 with the exception of chemotherapy induced alopecia & Gr.2 peripheral neuropathy
- •7.Clinical &/or biochemical evidence of hyperaldosteronism or hypopituitarism.
- •8.Use of drugs that are known strong CYP3A4 inducers and CYP2D6 substrates with a narrow therapeutic index. Seville orange or grapefruit products, and any herbal medications should be avoided 4 weeks prior to trial entry
- •9.Malabsorption syndrome or other condition that would interfere with enteral absorption
- •10.Intracerebral metastases
- •11.Any of the following cardiac criteria: •QT interval > 470 msec •Clinically important abnormalities including rhythm, conduction or ECG changes (left bundle branch block, third degree heart block) •Factors predisposing to QT prolongation including heart failure, hypokalemia, congenital long QT syndrome, family history of prolonged QT syndrome, unexplained sudden death (under 40) & concomitant medications known to prolong QT interval •Coronary artery bypass, angioplasty, vascular stent, myocardial infarction, angina or congestive heart failure (NYHA =gr.2) in the last 6 months
- •12.Uncontrolled hypotension (systolic blood pressure <90mmHg &/or diastolic blood pressure <50 mmHg)
- •13.Uncontrolled hypertension on optimal medication (systolic blood pressure >180, diastolic blood pressure >100)
- •14.Patients with known history of adrenal insufficiency or mineralocorticoid excess
- •15.Patients with a significant history of liver disease (Child-Pugh B or C, viral or other hepatitis, current alcohol abuse or cirrhosis)
- •16.Serologically positive for hep. B, hep. C or human immunodeficiency virus (HIV).
- •17.At high medical risk because of non-malignant systemic disease including active infection
- •18.Known history of tuberculosis
- •19.Poorly controlled type 2 diabetes with HbA1C >7.5
- •20.Malignancy other than prostate cancer within 3 years of trial entry with the exception of adequately treated basal cell carcinoma. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy must have no evidence of that disease for at least 3 years & be deemed at negligible risk for recurrence, are deemed eligible
- •21.Immunocompromised patients including patients who have previously received organ transplants or are on long-term immunosuppression
- •22.Active or uncontrolled autoimmune disease requiring corticosteroid therapy
- •23.Any other finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect interpretation of the results or renders the patients at high risk from treatment complicati
研究者
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