NL-OMON45198已完成2 期
A PHASE Ib/II STUDY OF IPATASERTIB (GDC-0068) OR APITILISIB (GDC-0980) WITH ABIRATERONE ACETATE VERSUS ABIRATERONE ACETATE IN PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER PREVIOUSLY TREATED WITH DOCETAXEL-BASED CHEMOTHERAPY - Genentech GO27983
GABA International0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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
- •Patients must meet all the following criteria to be eligible for study entry: 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, 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 (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 or 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. * 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.
排除标准
- •* 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.
- •* 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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