CTRI/2014/08/004922进行中（未招募）2 期
Phase II study to evaluate the safety, tolerability and efficacy of FOLFOX + CT-011 versus FOLFOX alone administered intravenously to patients with colorectal adenocarcinoma previously untreated for metastatic disease
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- CureTech Ltd
- 入组人数
- 171
- 试验地点
- 8
- 主要终点
- The primary endpoint will be the median progression free survival in patients treated with CT-011 plus FOLFOX compared to that of patients treated with FOLFOX alone. [ Time Frame: 32 months ]
研究概览
简要总结
The proposed clinical trial will be a multi-center, randomized, open label, active control study in previously untreated patients with metastatic colorectal cancer aimed to evaluate the safety, tolerability and efficacy of the monoclonal antibody, CT-011, administered at 3.0 mg/kg in combination with FOLFOX (FOLFOX4 or mFOLFOX6 compared with treatment by FOLFOX alone. Approximately 68 patients are planned to be enrolled to this study at 08 participating sites. This is a global trial including following countries:
Bulgaria India Peru Romania United States of America
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients age is 18 years or older, both genders.
- •2.Patients with metastatic disease who are eligible for first line FOLFOX chemotherapy.
- •Adjuvant or neoadjuvant given at least 12 months prior for non-metastatic disease is permitted.
- •3.ECOG performance status 8804; 1 4.At least 4 weeks from prior major surgery or radiotherapy.
- •5.Life expectancy greater than 3 months 6.Hematology: ANC 8805; 1.5X109 per Litre; Platelets greater than 100x109 per Litre.
- •7.Adequate Renal function 8.Adequate Hepatic functions 9.Normal Cardiac function.
排除标准
- •1.Patients who had adjuvant or neoadjuvant therapy for non-metastatic disease given within the last 12 months.
- •2.Patients who had received Oxaliplatin within 12 months prior to diagnosis of metastatic disease.
- •3.Patients on concurrent anti cancer therapy other than that allowed in the study.
- •4.Patients on concurrent steroids, other than those allowed for routine antiemetics, or inhaled steroids 5.Presence of clinically apparent or suspected brain metastasis.
- •6.Patients who have had myocardial infarction, severe congestive heart failure, or significant arrhythmia within the past 6 months.
- •7.Serious active infection at the time of pre-study screening.
- •8.Active or history of autoimmune disorders or conditions.
- •9.Women who are pregnant or lactating 10.Concurrent active malignancy.
- •11.Ascites, pleural effusions, or osteoblastic bone metastases as the only site of disease.
- •12.Other prior malignancies, except for cured or adequately treated malignancies for which there has been no evidence of activity for more than 5 years.
- •13.Subjects with a condition which may interfere with the subjects ability to understand the requirements of the study.
- •14.Patients with history of life threatening allergic reactions to food or drugs 15.Patients with symptomatic peripheral neuropathy greater than Grade
- •16.Known positive HIV, Hepatitis B surface antigen or Hepatitis C antibody.
结局指标
主要结局
The primary endpoint will be the median progression free survival in patients treated with CT-011 plus FOLFOX compared to that of patients treated with FOLFOX alone. [ Time Frame: 32 months ]
时间窗: Within 32months following the first CT-011 treatment
次要结局
- Objective response rate by RECIST.([ Time Frame: 32 months ] [Designated as safety issue: Yes])
- Response duration.([Time Frame: 32 months ] [Designated as safety issue: Yes])
- Tumor and immunological markers.([Time Frame: 32 months ] [Designated as safety issue: Yes ])
- Safety, tolerability, pharmacokinetics and immunogenicity of CT-011.([Time Frame: 32 months ] [Designated as safety issue: Yes])
- Progression-free survival rates.([Time Frame: 32 months ] Designated as safety issue: Yes])
- Overall survival.([Time Frame: 32 months ] [Designated as safety issue: Yes])
- Anti tumor activity of the antibody.([Time Frame: 32 months ] [Designated as safety issue: Yes])
研究者
研究点 (8)
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