A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 268
- 试验地点
- 83
- 主要终点
- Part 2: To compare progression-free (PFS) survival by independent review committee (IRC) between navtemadlin and placebo
研究概览
简要总结
This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy.
The study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT
- •Subjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1
- •Adequate hematologic, hepatic and renal function (within 14 days)
排除标准
- •Has any sarcomas or small-cell carcinomas with neuroendocrine differentiation
- •Prior immune therapy, cytokine therapy, or any investigational therapy (within 28 days)
- •Indwelling surgical drains
- •Grade 2 or higher QTc prolongation
- •History of major organ transplant
- •History of bleeding diathesis; major hemorrhage or intracranial hemorrhage (within 24 weeks)
研究组 & 干预措施
Part 1 Arm 2
Navtemadlin administered orally at 240 mg, once daily (QD) on Days 1-7 in a 28-day treatment cycles.
干预措施: Navtemadlin (Drug)
Part 1 Arm 1
Navtemadlin administered orally at 180 mg, once daily (QD) on Days 1-7 in a 28-day treatment cycles.
干预措施: Navtemadlin (Drug)
Part 2 Arm A
Navtemadlin administered orally at 180 mg once daily (QD) on Days 1-7 in a 28-day treatment cycles.
干预措施: Navtemadlin (Drug)
Part 2 Arm B
Navtemadlin administered orally at 240 mg once daily (QD) on Days 1-7 in a 28-day treatment cycles.
干预措施: Navtemadlin (Drug)
Part 2 Arm C
Placebo administered orally at 180 mg once daily (QD) on Days 1-7 in a 28-day administration cycle.
干预措施: Navtemadlin Placebo (Drug)
Part 2 Arm D
Placebo administered orally at 240 mg once daily (QD) on Days 1-7 in a 28-day administration cycle.
干预措施: Navtemadlin Placebo (Drug)
结局指标
主要结局
Part 2: To compare progression-free (PFS) survival by independent review committee (IRC) between navtemadlin and placebo
时间窗: 50 months
PFS defined as the time from randomization to disease progression by IRC or death, whichever occurs first
Part 1: To determine the navtemadlin Phase 3 dose
时间窗: 12 months
Safety review committee (SRC) will determine the navtemadlin Phase 3 dose for Part 2 based on safety data from Part 1
次要结局
- Part 2: To evaluate the treatment effect of navtemadlin on the time to first subsequent treatment (TFST)(50 months)
- Parts 1 and 2: To determine the pharmacokinetic (PK) profile of navtemadlin(1 day)
- Parts 1 and 2: To evaluate the treatment effect of navtemadlin on the disease control rate (DCR)(50 months)
- Part 1: To evaluate the treatment effect of navtemadlin on PFS by IRC and investigator assessment(50 months)