EUCTR2011-004126-10-CZ进行中（未招募）1 期
A PHASE Ib/II STUDY OF IPATASERTIB (GDC-0068) OR APITOLISIB (GDC-0980) WITH ABIRATERONE ACETATE VERSUS ABIRATERONE ACETATE IN PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER PREVIOUSLY TREATED WITH DOCETAXEL-BASED CHEMOTHERAPY
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 260
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
- •Patients must meet all the following criteria to be eligible for study
- •· Signed Informed Consent Form(s)
- •· Age =18 years
- •Histologically confirmed metastatic or advanced prostate adenocarcinoma that has been previously treated with docetaxel-based therapy and has progressed during treatment of at least one hormonal therapy (luteinizing hormone-releasing hormone, bicalutamide, etc.)
- •Availability at the site of a representative formalin-fixed, paraffin-embedded
- •tumor specimen that enabled the definitive diagnosis of prostate cancer, accompanied by an associated pathology report (required prior to randomization)
- •The specimen must contain adequate viable tumor cells (e.g., a minimum of 50 viable tumor cells or tumor tissue derived from prostatectomy or = 50% tumor content if sample is a core biopsy).
- •Specimen may consist of a tissue block (preferred) or 15-20 unstained, serial slides. Cytologic or fine-needle aspiration samples are not acceptable.
- •If archival tissue is either insufficient or unavailable, the patient may still be eligible, upon discussion with the Medical Monitor, assuming the patient Can provide = 5 unstained, serial slides
- •Is willing to consent to and undergo a pretreatment core or excisional biopsy of the tumor (if fresh biopsy is permitted by local regulatory authorities and ethics committees). Cytologic or fine-needle aspiration samples are not acceptable. Note that patients who undergo a fresh tumor biopsy will be eligible regardless of viable tumor cell content.
- •Two rising PSA levels = 2 ng/mL measured = 1 week apart during or following the most recent prior therapy for prostate cancer that meet the Prostate Cancer Working Group 2 (PCWG2) criteria for progression before initiation of study treatment or radiographic evidence of disease progression in soft tissue or bone, with or without disease progression on the basis of the
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 67
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 193
排除标准
- •Patients who meet any of the following criteria will be excluded from
- •study entry:
- •· Small cell or neuroendocrine prostate carcinoma
- •· History of Type I or Type II diabetes mellitus requiring insulin
- •Patients who are on a stable dose of oral diabetes medication = 4 weeks
- •prior to initiation of study treatment may be eligible for enrollment.
- •· Inability or unwillingness to swallow pills
- •· Malabsorption syndrome or other condition that would interfere with
- •enteral absorption
- •· Congenital long QT syndrome or QTc > 480 msec
研究者
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