NCT02705469已完成1 期
A Phase 1 Safety and Tolerability Study of ZEN003694 in Patients With Metastatic Castration-Resistant Prostate Cancer
Zenith Epigenetics6 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2016年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 6
- 主要终点
- For dose escalation only: Incidence of dose-limiting toxicities (DLT)
研究概览
简要总结
This is an open label, Phase 1, dose escalation and dose confirmation study of ZEN003694 in patients with mCRPC.
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
- •Males age ≥ 18 years
- •Metastatic, castrate resistant, histologically confirmed prostate cancer; surgically castrated or continuous medical castration for ≥ 8 weeks prior to screening
- •Serum testosterone < 50 ng/dL determined within 4 weeks of first administration of study drug
- •Prior progression on one or more androgen-receptor/androgen-synthesis inhibitor therapies (e.g. abiraterone, enzalutamide, apalutamide, TAK-700 and/or galeterone) by Prostate Cancer Working Group 2 (PCWG2) criteria. Prior progression on bicalutamide/nilutamide/flutamide/ketoconazole alone is not allowed.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Adequate laboratory parameters [absolute neutrophil (ANC), platelets, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, creatinine and coagulation parameters] at screening
排除标准
- •Any history of brain metastases or prior seizure or conditions predisposing to seizure activity
- •Have previously received an investigational BET inhibitor (including previous participation in this study or Study ZEN003694-002)
- •Have received prior systemic anti-cancer therapy or investigational therapy within 2 weeks or five half-lives, whichever is shorter, prior to the first administration of study drug
- •Failure to recover to Grade 1 or lower toxicity related to prior systemic therapy (excluding alopecia and neuropathy) prior to study entry
- •Radiation therapy within 2 weeks of first administration of study drug
- •Have received prior chemotherapy in the metastatic castration-resistant setting (prior chemotherapy in the hormone-sensitive setting is allowed provided last dose was at least 6 months prior to study entry)
- •Currently receiving medications known to be strong inducers or inhibitors of CYP3A4 with a narrow therapeutic window. Strong inducers and inhibitors of CYP3A4 with narrow therapeutic ranges must be discontinued at least 7 days prior to the first administration of study drug.
研究组 & 干预措施
Dose Escalation and Dose Confirmation - ZEN003694 Single Agent
Experimental
ZEN003694 will be administered orally as a single agent once daily in 28-day cycles, enrolling mCRPC patients.
干预措施: ZEN003694 (Drug)
结局指标
主要结局
For dose escalation only: Incidence of dose-limiting toxicities (DLT)
时间窗: Cycle 1 (Day 1 thru Day 28)
A DLT is a treatment-related, clinically significant adverse event or laboratory abnormality occurring during the first cycle of treatment (Day 1 thru Day 28).
For dose escalation and dose confirmation: Incidence of treatment-related adverse events (AE) and treatment-related serious adverse events (SAE)
时间窗: Up to 24 months
次要结局
- Evaluate prostate-specific antigen (PSA) response rate by PCWG2 criteria(From screening up to 24 months)
- Measure the pharmacokinetic (PK) parameter: AUC of ZEN003694(Cycle 1 Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 1 Day 2: pre-dose; Cycle 1 Day 15: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 2 Day 1: pre-dose)
- Measure the PK parameter: Cmax of ZEN003694(Cycle 1 Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 1 Day 2: pre-dose; Cycle 1 Day 15: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 2 Day 1: pre-dose)
- Measure the PK parameter: Cmin of ZEN003694(Cycle 1 Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 1 Day 2: pre-dose; Cycle 1 Day 15: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 2 Day 1: pre-dose)
- Measure the PK parameter: Tmax of ZEN003694(Cycle 1 Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 1 Day 2: pre-dose; Cycle 1 Day 15: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 2 Day 1: pre-dose)
- Measure the PK parameter: t1/2 of ZEN003694(Cycle 1 Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 1 Day 2: pre-dose; Cycle 1 Day 15: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 2 Day 1: pre-dose)
- Evaluate radiographic response rate by PCWG2 criteria(From screening up to 24 months)
- Evaluate median progression-free survival by PCWG2 criteria(From screening up to 24 months)
- Evaluate circulating tumor cell (CTC) response rate during dose confirmation phase only(From screening up to 12 months)
研究者
研究点 (6)
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