CTRI/2013/05/003699进行中（未招募）3 期
Prospective, multi-centre, randomized, open-label, two-arm,parallel group, active-control, comparative clinicalstudy to evaluate efficacy, safety and pharmacokineticsof R-TPR-023 and Avastinâ„¢ when given intravenously inpatients with Metastatic colorectal cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 105
- 试验地点
- 23
- 主要终点
- Outcome Name: Efficacy will be assessed as Objective Response Rate (Complete Response and Partial Response) by RECIST 1.1 criteria at 25 weeks
研究概览
简要总结
This is a prospective, multi-centre, open-label, two-arm, parallel group, active-control, randomized comparative clinical study. The present study will evaluate the efficacy
safety and pharmacokinetics of R-TPR-023 and Avastinâ„¢ in patients with Metastatic colorectal cancer.
The primary outcome measures will be to assess the efficacy as overall response rate (Complete Response and Partial Response) assessed by RECIST 1.1 criteria at 25 weeks.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient must have histologically or cytologically confirmed colorectal adenocarcinoma with metastatic disease documented on diagnostic imaging studies.
- •Patient must have measurable lesions as defined by modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- •Patients who agree to undergo the Magnetic Resonance Imaging (MRI) studies must have a metastatic lesion that is >2 cm.
- •Patient must not have previously received chemotherapy for metastatic disease.
- •Patients with estimated life expectancy >6 months
- •Patient may have received adjuvant therapy for primary colorectal cancer provided that at least 6 months have elapsed from the time the adjuvant therapy was concluded and recurrent disease was documented.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Patients must have adequate organ and marrow function as defined below: ・ • Absolute neutrophil count (ANC) ≥1,500/mm3; • Platelets ≥100,000/ mm3; hemoglobin ≥9 gm/dL (may be transfused to maintain or exceed this level); • Total Bilirubin ≤1.5 within institutional upper limit of normal (IULN); AST or SGOT/ALT or SGPT ≤ 2.5 times IULN, or ≤ 5 times IULN if known liver metastases; • Serum Creatinine ≤1.5 x IULN
- •Patients must have an International Normalized Ratio (INR) less than/equal to 1.5 and a Partial thromboplastin time (PTT) less than/equal to 1.5 IULN.
- •Patients with history of hypertension must be well-controlled (blood pressure less than/equal to 150/100), on a stable regimen of anti-hypertensive therapy.
- •Females of childbearing potential should be willing to use an approved method of double-barrier contraception and have to have a negative pregnancy test.
- •Able to understand the study procedures, the risks involved, willing to provide written Informed Consent, and able to adhere to study schedules and requirements.
排除标准
- •Participation in other clinical trial within 4 weeks of first infusion of this study.
- •Prior full field radiotherapy less than/equal to 4 weeks or limited field radiotherapy less than/equal to 2 weeks prior to treatment.
- •History or presence of central nervous system metastases.
- •Patient with history of prior treatment with bevacizumab or other agents targeting vascular endothelial growth factor (VEGF).
- •Known dihydropyrimidine dehydrogenase deficiency.
- •Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab, irinotecan, 5-FU, or leucovorin.
- •Serious non-healing wound, ulcer, or active bone fracture.
- •Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 0; anticipation of need for major surgical procedure during the course of the study.
- •Fine needle aspirations or core biopsies within 7 days prior to Day
- •Patients may have prophylactic use of low molecular weight heparin; however therapeutic use of heparin or low molecular weight heparin is not acceptable.
- •Evidence of bleeding diathesis or coagulopathy.
- •Patients with a history of another primary malignancy less than/equal to 5 years, with the exception of non-melanoma skin cancer, and carcinoma in situ of uterine cervix.
- •History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0, unless affected area has been removed surgically.
- •Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study: Uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with an antihypertensive regimen; Unstable angina; New York Heart Association (NYHA) greater than/equal to grade 2 congestive heart failure
- •Myocardial infarction within 6 months of study enrollment; History of stroke within 6 months of study enrollment; Unstable symptomatic arrhythmia requiring medication (Patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible); Clinically significant peripheral vasculardisease; Uncontrolled diabetes; Serious active or uncontrolled infection
- •History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.
- •Subjects with HIV, HBsAg, HCV test positive.
- •Any other condition which investigator feels would pose a significant hazard to subject if bevacizumab or chemotherapy is administered.
结局指标
主要结局
Outcome Name: Efficacy will be assessed as Objective Response Rate (Complete Response and Partial Response) by RECIST 1.1 criteria at 25 weeks
时间窗: 25 weeks
次要结局
- 1. To assess the disease progression free survival (PFS) rate And evaluate ORR at 25 weeks and 1 years(2. To determine single dose pharmacokinetics of R-TPR-023 and Avastinâ„¢)
研究者
研究点 (23)
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