A Phase 1b-2, Multicenter, Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of REC-4881 in Patients with Familial Adenomatous Polyposis (FAP)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Part 1: Plasma PK parameters as appropriate, including but not limited to maximum (peak) plasma drug concentration (Cmax), time to reach maximum (peak) plasma concentration following drug administration (Tmax), and area under the plasma concentration-time curve (AUC).
研究概览
简要总结
Part 1: •To evaluate the pharmacokinetics (PK) of REC-4881 Part 2: •To identify the Recommended Phase 2 Dose (RP2D) of REC-4881 •To assess the safety and tolerability REC-4881 •To evaluate the effect of REC-4881 on polyp burden
研究设计
- 分配方式
- Na
- 主要目的
- A Study To Find How Well Rec-4881 Works And How Safe It Is In Participants With Fap
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients that: • are at least 18 years old. • have been diagnosed with FAP, which continues to affect the remaining portions of the bowels after surgery to remove all or part of the colon. • have a confirmed change (mutation) in the APC gene (for Part 2).
排除标准
- •Patient that: • has abnormal test results or a health problem that could make it unsafe to take part in the study. • has received radiation treatment to the lower belly (pelvic area) in the past. • have cancer in the stomach, duodenum, colon, rectum, or pouch at screening (Part 2). • have a large polyp that cannot be completely removed. • are currently receiving treatment for cancer of the lower belly or have taken certain medicines that may interfere with REC-4881 before joining the study.
研究组 & 干预措施
REC-4881
干预措施: REC-4881 (Drug)
The placebo is formulated from inactive components of the REC-4881 4 mg capsules include: mannitol, microcrystalline cellulose,hydroxypropyl cellulose, croscarmellose sodium, and magnesium stearate.
干预措施: The placebo is formulated from inactive components of the REC-4881 4 mg capsules include: mannitol, microcrystalline cellulose,hydroxypropyl cellulose, croscarmellose sodium, and magnesium stearate. (Drug)
结局指标
主要结局
Part 1: Plasma PK parameters as appropriate, including but not limited to maximum (peak) plasma drug concentration (Cmax), time to reach maximum (peak) plasma concentration following drug administration (Tmax), and area under the plasma concentration-time curve (AUC).
Part 1: Plasma PK parameters as appropriate, including but not limited to maximum (peak) plasma drug concentration (Cmax), time to reach maximum (peak) plasma concentration following drug administration (Tmax), and area under the plasma concentration-time curve (AUC).
Part 2: •Treatment emergent adverse events and DLTs •Serious adverse events •Treatment discontinuation and dose modification due to toxicity •Percent change from baseline in polyp burden after 12 weeks, 25 weeks, and 37 weeks (Interval Dosing regimen only) and EoT
Part 2: •Treatment emergent adverse events and DLTs •Serious adverse events •Treatment discontinuation and dose modification due to toxicity •Percent change from baseline in polyp burden after 12 weeks, 25 weeks, and 37 weeks (Interval Dosing regimen only) and EoT
次要结局
- Part 1: •Treatment emergent adverse events •Serious adverse events •Treatment discontinuation and dose modification due to toxicity
- Part2: •PK parameters including but not limited to: Cmax, Tmax, trough plasma concentrations (Ctrough), and AUCtau Change from baseline in: •Polyp number •Polyp number >5 mm •Highest histological grade •Spigelman Stage Classification for duodenal polyposis •InSiGHT Stage for rectal/pouch polyposis
研究者
Michelle Boytim
Scientific
Recursion Pharmaceuticals Inc.