NL-OMON34099已完成不适用
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD3514 in Patients with Metastatic Castration-Resistant Prostate Cancer - SARD
Astra Zeneca0 个研究点目标入组 17 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
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
- •- Provision of signed and dated written informed consent
- •- Males aged 20 years or older
- •- Histologically or cytologically proven prostate cancer for which no standard therapy is currently considered appropriate
- •- Documented evidend of metastatic prostate cancer
- •- Presence of progressive disease as defined as one or more:
- •* Biochemical progression of the prostate cancer, defined as at least 2 stepwise increases in a series of any 3 PSA values collected while patient is castrate. The 3 PSA values selected do not need to be consecutive, and do not need to include the most recent PSA collected at, or prior to, study enrolment but must meet the following criteria:
- •i. There must be at least 14 days between each of the 3 PSA values, and each must be collected no more than 1 year before enrolment into the study
- •ii. The last PSA value in the series of the 3 must be either an increase of > 25% of the first PSA or an absolute increase of >10 ng/mL over the first PSA
- •iii. The last PSA value in the series of 3 must be > 1.2 ng/mL in patients who have had a radical prostatectomy and > 5 ng/mL in all other patients
- •iv. Each of the 3 PSA values must be collected whilst the patient is under medical castration or is surgically castrated
- •v. All PSA increases should be recorded after withdrawal of anti-androgen therapy
- •vi. All 3 PSA values must have been acquired after commencement of the last line of systemic therapy, including corticosteroids regardless of the therapeutic intent
- •* Progression as defined by RECIST 1.1
- •* Two or more new metastatic bone lesions from bone scans from a previous assessment
- •- Serum testosterone concentration < 50 ng/dL
- •- WHO performance status 0 to 1
- •- Patients should use condoms
排除标准
- •- Treatment with any of the following:
- •* Nitrosourea or mitomycin C within 6 weeks of the first dose of study treatment
- •* 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 selective androgen-receptor down-regulator
- •* Any other chemotherapy, immunotherapy or anticancer agents within 3 weeks of the first dose of
- •study treatment
- •* Any hormonal therapy (e.g. steroids) within 4 weeks of the first dose of study treatment (6 weeks
- •for anti-androgens). The use of LHRH-analogues is permitted. Concomitant use of steoids e.g. including but not limited to prednisolone, prednisone or dexamethasone is permitted if being administered as a supportive care agent
- •* Potent inhibitors or inducers of CYP3A4 within 2 weeks before the first dose of study treatment (3 weeks for St John*s Wort)
- •* AZD3514 in the present study
- •* Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study
- •*Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of
- •radiation for palliation within 2 weeks of the first dose of study treatment
- •- With the exception of alopecia or toxicities related to the use of gonadotropin-releasing hormone
- •agonists, any unresolved toxicities from prior therapy greater than Common Terminology Criteria
- •for Adverse Events (CTCAEv4) grade 1 at the time of starting study treatment
- •- 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 treatment
- •- 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 HIV.
- •- Any of the following cardiac criteria (see protocol)
- •- Inadequate bone marrow reserve or organ function as demonstrated by any of the following
- •laboratory values:
- •* Absolute neutrophil count < 1.5 x 109/L
- •* Platelet count < 100 x 109/L
- •* Haemoglobin < 90 g/L
- •* Alanine aminotransferase > 2.5 times the upper limit of normal (ULN) if no demonstrable liver
- •metastases or > 5 times ULN in the presence of liver metastases
- •* Aspartate aminotransferase > 2.5 times ULN if no demonstrable liver metastases or > 5 times
- •ULN in the presence of liver metastases
- •* Total bilirubin > 1.5 times ULN if no liver metastases or > 3 times ULN in the presence of liver
- •* Creatinine >1.5 times 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 times ULN
- •- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the
- •formulated product or previous significant bowel resection that would preclude adequate absorption of AZD3514
- •- History of hypersensitivity to active or inactive excipients of AZD3514 or drugs with a similar
- •chemical structure or class to AZD3514
- •- Judgment by the investigator that the patient should not participate in the study if the patient is
- •unlikely to comply with study procedures, restrictions and requirements
- •- Involvement in the planning and conduct of the s
研究者
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