NCT01748500已完成2 期
Pantoprazole and Docetaxel for Men With Metastatic Castration-Resistant Prostate Cancer - a Single Arm Phase II Clinical Trial With a Predefined Reference Group (PANDORA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Confirmed PSA response
研究概览
简要总结
The main objectives of this trial are:
- To assess the activity and safety of pantoprazole and docetaxel (with prednisone) in men with metastatic CRPC who have not received prior chemotherapy.
- To evaluate archival prostate cancer tissue of men included in the clinical trial for evidence of autophagy using IHC for LC3B, ATG5, p62 as well as ERG.
- To evaluate pharmacokinetic interactions of pantoprazole with docetaxel.
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
- •Age ≥18yrs
- •ECOG performance status ≤2
- •Histologically or cytologically confirmed adenocarcinoma of the prostate
- •Clinical or radiological evidence of metastatic disease
- •Disease progression while receiving androgen deprivation therapy with an increase in PSA of 25% or greater over nadir value measured on 3 consecutive occasions at least 1 week apart
- •Antiandrogen therapy must have been stopped at least 4 weeks prior to start of trial treatment (6 weeks in the case of bicalutamide or nilutamide)if there was a reduction in serum PSA after this therapy was initiated
- •Baseline serum prostate-specific antigen (PSA)≥10ng/ml
- •Total testosterone <50 ng/dL (<1.7 nmol/L)
- •Adequate hematologic values: neutrophil count ≥1,500/mm3, platelet ≥100,000/mm3, hemoglobin ≥10.0 g/dl
- •Adequate hepatic and renal function: total bilirubin level ≤1.5 x ULN (unless secondary to documented Gilbert's disease); ALT,AST, and creatinine ≤1.5 x ULN
- •Ability to understand and to sign consent for the study
排除标准
- •Prior treatment for prostate cancer with chemotherapy or radioisotopes
- •History of another cancer within the preceding five years (except basal or squamous-cell skin cancer or adequately treated superficial bladder cancer)
- •Known or suspected brain or leptomeningeal metastases
- •Symptomatic peripheral neuropathy of grade 2 or higher
- •Major surgery within 4 weeks of start of trial treatment
- •Radiotherapy to ≥25% of the bone marrow and any radiotherapy within 4 weeks of start of trial treatment
- •Known hypersensitivity to trial treatment or hypersensitivity to any of its components
- •Any concomitant drugs contraindicated for use with the trial treatment
- •Any serious underlying medical condition which could impair the ability of the patient to participate in the trial
- •Any psychological, familial, sociological or other patient related factors that might preclude compliance with the study protocol
研究组 & 干预措施
Pantoprazole, Docetaxel, Prednisone
Experimental
干预措施: Pantoprazole (Drug)
结局指标
主要结局
Confirmed PSA response
时间窗: 20 months
The primary endpoint is met if PSA falls to ≤50% of baseline, maintained for ≥3 weeks.
次要结局
未报告次要终点
研究者
研究点 (1)
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