An Open-Label, Multicenter, Phase 2 Study of Single-Agent CNTO 888 (an Anti-CCL2 Monoclonal Antibody) for the Treatment of Subjects With Metastatic Castrate-Resistant Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 主要终点
- Percentage of Participants With Composite Response
研究概览
简要总结
The purpose of this study is to determine the safety and effectiveness of the study drug carlumab in participants with metastatic castrate-resistant prostate cancer (cancer of the gland that makes fluid that aids movement of sperm).
详细描述
This is an open-label (all people know the identity of the intervention), multicenter trial (conducted in more than one center) in participants with metastatic castrate-resistant prostate cancer. The trial consists of 3 phases: screening period, treatment period of approximately 4 months, and a follow-up period (Week 1, 4, 8 and 12 after the last dose) of up to 12 weeks after the administration of last dose. The participants will receive carlumab at the dose of 15 milligram/kilogram (mg/kg) by intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) at a constant rate over a 90 minute period once every 2 weeks until disease progression. Efficacy of the participants will be primarily evaluated by composite response. Participants' safety will be monitored throughout the 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
- •Histological documentation of adenocarcinoma of the prostate
- •Received at least 1 but no more than 2 prior docetaxel-based chemotherapy regimens and had disease progression following the last therapy
- •Serum prostate specific antigen (PSA) greater than or equal to 5.0 nanogram/milliliter (ng/ml) within 4 weeks prior to the first dose of study agent
- •Orchiectomy (surgery to remove one or both testicles) or testosterone less than 50 nanogram/deciliter by means of pharmacological/chemical castration within 4 weeks prior to the first dose of study agent
- •At least 6 weeks from prior docetaxel chemotherapy regimen to first dose of study agent
排除标准
- •Experience a hormonal treatment withdrawal response (including a lowering of PSA that was previously rising or symptomatic improvement)
- •Known or symptomatic Central Nervous System metastases
- •Residual toxicities resulting from previous therapy that are Grade 2 or more (except for alopecia)
- •Known allergies, hypersensitivity, or intolerance to carlumab or its excipients or clinically significant reactions to chimeric or human proteins
- •Vaccinated with live, attenuated vaccines within 4 weeks prior to the first dose of study agent
研究组 & 干预措施
Carlumab
干预措施: Carlumab (Drug)
结局指标
主要结局
Percentage of Participants With Composite Response
时间窗: Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab
The composite response is measured by change from Baseline in skeletal lesions, extra-skeletal lesions, and prostate specific antigen (PSA) values. A participant is considered to have composite response, if 1 of the following responses occurs after the first dose of carlumab: (1) Complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST), (2) PSA response at 12 weeks and absence of skeletal and extra-skeletal progression or (3) Stable disease at 24 weeks defined as the absence of PSA, skeletal, or extra-skeletal progression.
次要结局
- Maximum Observed Serum Concentration (Cmax)(Pre-dose and at the end of infusion for each Dose; 2, 4 hour (hr) and 1 week after Dose 1; 2 hr after Dose 4; Week 1, 4, 8 and 12 post-last dose)
- Area Under the Serum Concentration Versus Time Curve Between 0 And 14 Days (AUC 0-14d)(Pre-dose, at the end of infusion, 2, 4 hr and 1 week after end of infusion for the first dose)
- Percentage of Participants With Objective Tumor Response(Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab)
- Progression-Free Survival (PFS)(Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab)
- Overall Survival (OS)(Week 8, 12, every 12 weeks up to 1 year after last dose of carlumab)
- Percentage of Participants With Prostate Specific Antigen (PSA) Response(Up to 2 weeks before first dose, every 4 weeks after first dose, Week 4, 8, 12 after the last dose of carlumab)
- Percentage of Participants With Urinary Crosslinked N-Telopeptide of Type I Collagen (NTx) Response(Up to 2 weeks before first dose, every 4 weeks after first dose, Week 4, 8, 12 after the last dose of carlumab)
- Percentage of Participants With Pain Response(Up to 2 weeks before first dose, every 4 weeks after first dose, Week 4 after last dose of carlumab)
- Time to Radiologic Response(Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab)
- Duration of Radiologic Response(Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab)
- Minimum Observed Serum Concentration (Cmin)(Pre-dose and at the end of infusion for each Dose; 2, 4 hour (hr) and 1 week after Dose 1; 2 hr after Dose 4; Week 1, 4, 8 and 12 post-last dose)
- Half-life (t1/2)(Pre-dose and at the end of infusion for each Dose; 2, 4 hour (hr) and 1 week after Dose 1; 2 hr after Dose 4; Week 1, 4, 8 and 12 post-last dose)