NCT01370070已完成2 期
Multicenter Phase II Study of MK-2206 in Previously Treated Patients With Recurrent and Metastatic Nasopharyngeal Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- The proportion of patients alive and progression-free at 6 months along with the confirmed response rate as a dual primary endpoint
研究概览
简要总结
To evaluate the activity and safety of MK-2206 in patients with recurrent or metastatic nasopharyngeal carcinoma (NPC)
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
- All
- 接受健康志愿者
- 否
入选标准
- •Aged > 18 year, able to give written informed consent.
- •History of histologically or cytologically confirmed non-keratinizing NPC that has recurred at locoregional and/or distant sites, and is not amenable to potentially curative radiotherapy or surgery.
- •Patients must have progressed within 24 months of receiving one or two prior line of chemotherapy for recurrent disease, of which at least one line must contain platinum drugs such as Cisplatin, Carboplatin or oxaliplatin.
- •Adequate organ reserve: neutrophils >1.5x109/L, platelets ≥100 x109/L, hemoglobin ≥9 g/dL, serum alanine aminotransferase (ALT) < 2.5 x upper limit of normal (ULN) or ALT< 5 x ULN in the presence of liver metastases, serum bilirubin < 2.5 x ULN, serum creatinine < 1.5 x ULN.
- •Presence of measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST ver 1.1).
排除标准
- •Chemotherapy, radiotherapy (except to bone metastases) or investigational treatment within 4 weeks of enrollment.
- •Patients with diabetes or in risk for hyperglycemia should not be excluded from trials with MK-2206, but the hyperglycemia should be well controlled before the patient enters the trial.
- •Cardiovascular: baseline QTcF > 450 msec (male) or QTcF >470 msec (female) Left bundle branch block, 2nd or 3rd degree AV block, bifascicular block, sick sinus syndrome, Wolff-Parkinson-white syndrome, significant sinus bradycardia (< 50bpm) . However, patients with asymptomatic right bundle branch block or 1st degree AV block, in the absence of known cardiac disease (e.g. coronary, valvular) are NOT excluded..
- •Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
研究组 & 干预措施
MK-2206
Experimental
干预措施: MK-2206 (Drug)
结局指标
主要结局
The proportion of patients alive and progression-free at 6 months along with the confirmed response rate as a dual primary endpoint
时间窗: 3 years
次要结局
- RECIST-based subjective response(3 Years)
- Laboratory correlates: pharmacokinetics, plasma EBV DNA half-life(3 years)
- treatment tolerability(2 years)
- Adverse events(2 Years)
- Progression-free survival(3 Years)
- Overall survival(3 years)
- duration of response(3 years)
研究者
CCTU
Comprehensive Cancer Trial Units
Chinese University of Hong Kong
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Akt Inhibitor MK2206 in Treating Patients With Recurrent or Metastatic Head and Neck CancerRecurrent Squamous Cell Carcinoma of the NasopharynxStage IV Squamous Cell Carcinoma of the NasopharynxNCT01349933National Cancer Institute (NCI)21
已完成
1 期
A Study of MK2206 in Locally Advanced or Metastatic Solid Tumors (2206-007)Solid TumorsNCT01071018Merck Sharp & Dohme LLC24
终止
2 期
Study of MK 2206 in Patients With Relapsed or Refractory Diffuse Large B Cell LymphomaDiffuse Large B Cell LymphomaNCT01466868Centre Leon Berard22
已完成
1 期
A Combination Therapy Study of MK-2206 and AZD6244 in Participants With Advanced Solid Tumors (MK-2206-010)Locally Advanced or Metastatic Solid TumorsNCT01021748Merck Sharp & Dohme LLC63
已完成
2 期
Akt Inhibitor MK2206 in Treating Patients With Advanced Gastric or Gastroesophageal Junction CancerAdenocarcinoma of the Gastroesophageal JunctionDiffuse Gastric AdenocarcinomaGastric Intestinal Type AdenocarcinomaGastric Mixed AdenocarcinomaRecurrent Gastric CarcinomaNCT01260701National Cancer Institute (NCI)75