NCT02118064已完成2 期
A Multinational, Multicenter, Open-label, Single-arm, Phase II Study of G17DT Immunogen in Combination With Irinotecan in Metastatic Colorectal Carcinoma Refractory to Previous Irinotecan-based Chemotherapy.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 161
- 主要终点
- Survival time
研究概览
简要总结
This study was designed to evaluate the ability for G17DT to slow or arrest tumor growth in patients with refractory colon cancer who had been previously treated with an Irinotecan-based chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Have histologically confirmed cancer of the colon or rectum or both and objective evidence of distant metastases
- •Have measurable disease
- •Have previously been treated with an irinotecan based chemotherapy
- •Have progressive metastatic disease after an irinotecan containing chemotherapy regimen (alone or in combination) for metastatic colorectal cancer
- •Be at least 18 years of age
- •Have laboratory data as specified below:
- •Aspartate aminotransferase (AST) and ALT less than 2.5 times upper limit of normal
- •Bilirubin less than 1.5 mg/dL (SI units, 25.65 mol/L)
- •Creatinine less than 1.5 mg/dL (SI units, 132 mol/L)
- •White blood cell (WBC) count greater than 3,000/mm3
- •Platelets greater than 100,000/mm3
- •Hemoglobin more than 9.5 g/dL (SI units, 5.9 mol/L)
- •International normalized ratio of prothrombin time less than 1.2, and activated partial thromboplastin time no more than 5 seconds above normal limits
- •Have a life expectancy of at least 3 months
- •Have a KPS score of 70 or greater
- •Use contraceptive methods, if sexually active
- •Have the ability to understand the requirements of the study, to provide written informed consent, agree to abide by the study restrictions, and agree to return for the required assessments
排除标准
- •Be pregnant or nursing
- •Have only symptomatic locally recurrent colorectal cancer
- •Have had any active cancer in addition to metastatic colorectal cancer within the last 5 years except curatively treated nonmelanomatous skin cancer
- •Have received any prior anticancer immunotherapy
- •Have central nervous system metastasis, whether treated or not
- •Have bone metastases as sole manifestation of metastatic colorectal cancer
- •Have received chemotherapy within the previous 21 days
- •Have had major surgery within 21 days
- •Have immunodeficiency (primary or acquired)
- •Have undergone bone marrow transplantation within the last year
- •Require chronic administration of corticosteroids; inhaled corticosteroids for asthma and chronic obstructive pulmonary disease are allowed
- •Use in the past 30 days or concomitant use of immunosuppressants, including systemic (i.e., oral or injected) corticosteroids
- •Have participated in any clinical trial involving conventional or investigational drugs or devices within 21 days before G17DT irinotecan administration
- •Have contraindication to irinotecan based therapy
- •Have hypersensitivity to diphtheria toxoid
- •Use in the past 14 days or chronic concomitant use of proton pump inhibitors
- •Have uncontrolled serious cardiovascular or metabolic disease or any other uncontrolled serious medical or psychiatric illness
- •Have any condition that is likely to detrimentally affect regular follow up
结局指标
主要结局
Survival time
时间窗: up to 12 months
The vital status of patients was monitored until death or end of the study.
Number of Patients with Serious and Non-Serious Adverse Events
时间窗: Up to 12 months
Adverse events, defined as any event involving adverse reactions, illnesses with onset during the study, or exacerbations of pre-existing illnesses, were assessed at each visit.
Tumor response
时间窗: up to 12 months
Evaluate the effect of G17DT-Irinotecan combination therapy on tumor response assessed by magnetic resonance imaging or computed tomography.
次要结局
未报告次要终点
研究者
相似试验
已完成
2 期
Safety and Efficacy of G17DT Immunogen in the Treatment of Gastric and Gastroesophageal CancerStomach NeoplasmsEsophageal NeoplasmsNCT00042510Cancer Advances Inc.103
已完成
3 期
Safety and Efficacy of G17DT Immunogen Combined With Gemcitabine vs. Gemcitabine in the Treatment of Advanced Pancreatic CarcinomaPancreatic CancerNCT00044031Cancer Advances Inc.394
已完成
2 期
GW572016 to Treat Recurrent Malignant Brain TumorsGliosarcomaGliomaGlioblastoma MultiformeBrain TumorGBMGSNCT00107003National Cancer Institute (NCI)9
已完成
1 期
Study of Intravenous TCD-717 in Patients With Advanced Solid TumorsAdvanced Solid TumorsNCT01215864Traslational Cancer Drugs Pharma, SL28
已完成
2 期
Study to Determine the Antibody Response to 500µg G17DT in Treatment of Patients With Gastric CancerGastric CancerNCT02450032Cancer Advances Inc.12