NCT04575766终止1 期
A Phase 1 Study of FT-7051 in Men With Metastatic Castration-Resistant Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 8
- 主要终点
- Incidence of dose limiting toxicities (DLTs)
研究概览
简要总结
This is a Phase 1, open-label study that will evaluate the safety and tolerability of FT-7051 and determine the recommended Phase 2 dose (RP2D) as well as pharmacokinetics (PK), preliminary anti-tumor activity, and pharmacodynamics (PD) of FT-7051 in men with metastatic castration-resistant prostate cancer who have progressed despite prior therapy and had been treated with at least one potent anti-androgen therapy.
The starting dose, 25 mg once daily (QD), of FT-7051 administered discontinuously (21 days on/7 days off) in 28-day cycles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Signed informed consent
- •Diagnosis of progressive metastatic castration-resistant prostate cancer (mCRPC)
- •Previously failed at least one potent anti-androgen therapy
- •Castrate levels of serum testosterone
- •ECOG performance status 0-2
- •Adequate bone marrow function
- •Adequate kidney, heart and liver function
排除标准
- •Prior solid organ transplant
- •Prior treatment with small molecules including chemotherapy, antibody, or other experimental anticancer therapeutic within 4 weeks of first dose of study treatment
- •Prior radiation therapy within 4 weeks prior to initiation of study treatment (including radiofrequency ablation)
- •Prior androgen antagonist therapy (enzalutamide, apalutamide, abiraterone acetate, or darolutamide) within 2 weeks
- •Prior radium-223 therapy within 6 weeks
- •Symptomatic, untreated or actively progressing central nervous system (CNS) metastasis
- •Unstable or severe, uncontrolled medical condition (e.g., unstable cardiac function, unstable pulmonary condition including pneumonitis and/or interstitial lung disease, uncontrolled diabetes, active or uncontrolled infection requiring systemic therapy) or any important medical illness or abnormal laboratory finding that would, in the Investigator's judgement, increase the risk to the patient associated with participation in the study
- •Concomitant medications that cause Torsades de Pointes that have not reached steady state before first dose of the study drug
- •Concomitant medications that are strong inhibitors or inducers of CYP3A4 or an inhibitor of P-gp
- •History of infection with human immunodeficiency virus (HIV)
- •Active infection with hepatitis B, or hepatitis C virus
研究组 & 干预措施
Dose escalation study of FT-7051
Experimental
干预措施: FT-7051 (Drug)
结局指标
主要结局
Incidence of dose limiting toxicities (DLTs)
时间窗: Within first 4 weeks of treatment
Serious adverse events (SAEs) and clinically relevant adverse events (AEs)
时间窗: The treatment duration, predicted average 26 weeks
Incidence of clinical laboratory abnormalities as assessed by CTCAE v5.0
时间窗: The treatment duration, predicted average 26 weeks
次要结局
- Time to radiographic progression (rTTP)(The treatment duration, predicted average 26 weeks)
- Prostate-specific antigen (PSA): Maximum Decrease from Baseline(The treatment duration, predicted average 26 weeks)
- Prostate-specific antigen (PSA): Time to Progression(The treatment duration, predicted average 26 weeks)
- Apparent plasma clearance (CL/F)(Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment)
- Apparent volume of distribution (Vd/F)(Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment)
- Model-based estimate of change from baseline QT interval corrected using Fridericia's correction formula (QTcF) and 90% confidence interval at the estimated Cmax(Electrocardiogram collected at multiple timepoints during the first 45 days of treatment)
- Overall response rate: radiographic response rate(The treatment duration, predicted average 26 weeks)
- Complete response rate(The treatment duration, predicted average 26 weeks)
- Area under the plasma concentration versus time curve (AUC)(Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment)
- Prostate-specific antigen (PSA): Percent Change from Baseline(12 weeks)
- Peak Plasma Concentration (Cmax)(Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment)
- Time of peak plasma concentration (Tmax)(Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment)
- Terminal elimination half-life (T 1/2)(Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment)
研究者
研究点 (8)
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