NCT03243331已完成1 期
An Initial Safety Study of Gedatolisib Plus PTK7-ADC for Metastatic Triple-negative Breast Cancer
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
- Kathy Miller
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Safety of Gedatolisb + PTK7-ADC using NCI CTCAE v4.0
研究概览
简要总结
Phase 1 study to evaluate the safety and effect of Gedatolisib and PTK7-ADC for the treatment of triple negative breast cancer
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
- All
- 接受健康志愿者
- 否
入选标准
- •Metastatic Triple-negative Breast Cancer
- •Willingness to undergo tumor biopsy
- •Patients must have received at least 1 prior chemotherapy regimen for metastatic disease
排除标准
- •Previous treatment with mTOR inhibitor
- •Untreated brain metastases
研究组 & 干预措施
Gedatolisb + PTK7-ADC
Experimental
干预措施: Gedatolisib (Drug)
Gedatolisb + PTK7-ADC
Experimental
干预措施: PTK7-ADC (Drug)
结局指标
主要结局
Safety of Gedatolisb + PTK7-ADC using NCI CTCAE v4.0
时间窗: through study completion i.e. up to 1 year
safety and toxicity data will be assessed using NCI CTCAE v4.0 and tabulated and reported
次要结局
- Pharmacodynamic determination of inhibition of PI3k signaling(Cycle 1 Day 15)
- Pharmacodynamic determination modulation of Wnt pathway(Cycle 1 Day 15)
- Overall response rate in all enrolled subjects(through study completion i.e. up to 1 year)
- Efficacy in all enrolled subjects(18 weeks)
- Progression free survival in all enrolled subjects(through study completion i.e. up to 1 year)
研究者
Kathy Miller
Professor of Medicine
Indiana University
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Safety and Efficacy of Oral PTK787 in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (AMD)Wet Age-Related Macular DegenerationNCT00138632Novartis50
撤回
1 期
Gedatolisib, Hydroxychloroquine or the Combination for Prevention of Recurrent Breast Cancer ("GLACIER")Breast CancerNCT03400254Abramson Cancer Center at Penn Medicine
已完成
2 期
Study to Assess Safety & Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodiol.Primary Biliary CirrhosisNCT03226067Calliditas Therapeutics AB111
进行中（未招募）
1 期
Study of TL117 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell CarcinomaHead and Neck Squamous Cell CarcinomaNCT04843098Suzhou Junde Biotechnology Co., Ltd108
已完成
3 期
A Study of TAK-771 in Japanese Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal Motor Neuropathy (MMN)Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)Multifocal Motor Neuropathy (MMN)NCT05084053Takeda26