临床试验/NCT00513071

NCT00513071已完成2 期

A Phase II Trial of AZD0530 in Hormone Refractory Prostate Cancer (HRPC)

National Cancer Institute (NCI)1 个研究点分布在 1 个国家目标入组 28 人开始时间: 2007年8月最近更新: 2018年4月19日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: National Cancer Institute (NCI)
入组人数: 28
试验地点: 1
主要终点: PSA Response Rate

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This phase II trial is studying how well AZD0530 works in treating patients with prostate cancer that did not respond to hormone therapy. AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

详细描述

PRIMARY OBJECTIVES:

I. To test the hypothesis that AZD0530 will improve the prostate-specific antigen (PSA) response rate and progression-free survival (PFS) in comparison with historical controls for patients with hormone-refractory prostate cancer (HRPC).

II. Evaluate the time to treatment failure and overall survival of patients with HRPC treated with AZD0530.

III. Evaluate the toxicities and tolerance of AZD0530 therapy in the HRPC population.

OUTLINE: This is a multicenter study.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: Male
接受健康志愿者: 否

入选标准

•Histologically or cytologically confirmed prostate cancer with a Gleason score available or interpretable and meeting 1 of the following criteria:
•No prior chemotherapy and relatively minimal cancer spread
•Only one prior taxane-based chemotherapy for aggressive and/or symptomatic disease
•Must have prostate cancer considered to be hormone refractory or androgen independent by one or more of the following criteria (despite androgen deprivation and anti-androgen withdrawal when applicable):
•Progression of unidimensionally measurable disease assessed within 28 days prior to initial administration of drug
•Progression of evaluable but not measurable disease assessed within 28 days prior to initial administration of drug for PSA evaluation and within 42 days for imaging studies (e.g., bone scans)
•Patients must have nonmeasurable disease (e.g., nuclear medicine bone scans) and non-target lesions (e.g., PSA level) assessed within 28 days prior to initial administration of drug
•Measurable disease is not required but is allowed
•Must be surgically or medically castrated
•If the method of castration was luteinizing hormone-releasing hormone (LHRH) agonists (e.g., leuprolide or goserelin), then the patient must be willing to continue the use of LHRH agonists
•Serum testosterone must be at castrate levels (< 50 ng/dL) at least 3 months prior to registration
•ECOG performance status 0-2
•WBC >= 3,000/uL
•Absolute neutrophil count >= 1,500/uL
•Platelets >= 100,000/uL
•Hemoglobin > 9 g/d
•Total bilirubin within normal institutional limits
•AST/ALT =< 2.5 x institutional upper limit of normal
•Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min
•Must agree to use adequate contraception prior to study entry and for the duration of study participation
•At least 3 weeks since the completion of chemotherapy and radiotherapy and the patient must have recovered from the side effects of the therapy
•At least 28 days since prior non-steroidal anti-androgens (e.g., flutamide) (42 days for bicalutamide or nilutamide) or hormonal treatment (e.g., ketoconazole) and demonstrated progression of disease since the agents were suspended
•Concurrent bisphosphonate therapy is allowed

排除标准

•Known brain metastases
•History of allergic reactions attributed to compounds of similar chemical or biological composition to AZD0530
•Patients with any of the following conditions that impair the ability to swallow AZD0530 tablets
•Gastrointestinal tract disease resulting in an inability to take oral medication or requiring IV alimentation
•Prior surgical procedures affecting absorption
•Active peptic ulcer disease
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
•Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier
•Use of specifically prohibited CYP3A4-active agents or substances
•Prohibited drugs should be discontinued 7 days prior to the administration of the first dose of AZD0530 and for 7 days following discontinuation of AZD0530
•Patients receiving any other investigational agents
•No investigational or commercial agents or therapies other than study drugs may be administered with the intent to treat the patient's malignancy
•HIV-positive patients on combination antiretroviral therapy

研究组 & 干预措施

Treatment (saracatinib)

Experimental

Patients receive oral AZD0530 once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.

干预措施: saracatinib (Drug)

Treatment (saracatinib)

Experimental

Patients receive oral AZD0530 once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.

干预措施: laboratory biomarker analysis (Other)

结局指标

主要结局

PSA Response Rate

时间窗: PSA measured every 4 weeks

Complete Response (CR), disappearance of all measurable and non-measurable disease. No new lesions. PSA ≤ 0.2 ng/mL; Partial Response (PR), a decline in PSA by at least 30%, confirmed by a second PSA value four or more weeks later; Overall Response (OR) = CR + PR

次要结局

Toxicity Data(Up to 2 years)
N-telopeptide and Deoxypyridinoline as Prognostic Bone Markers(At baseline, at 6 hours, at each course (day 1), and at 2 years)
Time to Treatment Failure(From first day of treatment until discontinuation of treatment, up to 2 years)
Progression-free Survival (PFS)(From start of treatment until progression or death, up to 2 years)
Overall Survival(From start of treatment, up to 5 years)
Relationship Between Changes in Laboratory Correlates and Response and Survival(Up to 2 years)

研究者

发起方

National Cancer Institute (NCI)

申办方类型

Nih

责任方

Sponsor

研究点 (1)

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