EUCTR2011-004126-10-NL进行中（未招募）不适用
A PHASE Ib/II STUDY OF GDC-0068 OR GDC-0980 WITH ABIRATERONE ACETATE VERSUS ABIRATERONE ACETATE IN PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER PREVIOUSLY TREATED WITH DOCETAXEL-BASED CHEMOTHERAPY
适应症
相关药物
试验速览
- 阶段
- 不适用
- 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 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, paraffinembedded 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 (= 20% for excisional biopsy and = 50% 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. Cytologic or fine-needle aspiration samples are not
- •acceptable.
- •· 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 PSA value
- •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 65
- •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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