EUCTR2013-004262-34-FR进行中（未招募）1 期
Phase II, randomized, controlled, clinical trial exploring efficacy and safety of ERY001 (L-asparaginase encapsulated in Red Blood Cells) in association with gemcitabine or FOLFOX4 in second-line therapy for patients with progressive metastatic pancreatic carcinoma.
ERYTECH Pharma0 个研究点目标入组 90 人开始时间: 2014年2月28日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patients with progressive metastatic exocrine pancreatic adenocarcinoma, confirmed histologically
- •- Patients with available histology specimen, either from primary tumor and/or from metastatic lesions. The IHC analyses (done in a central laboratory) issued from these specimens MUST allow determining the level of asparagine synthetase expression. Such result is mandatory for the final analysis
- •- Patient eligible to 2nd line gemcitabine or FOLFOX4 treatment according investigator’s decision.
- •- Measurable lesion (>1cm) as assessed by CT scan or MRI (Magnetic Resonance Imaging) according to RECIST criteria (version 1.1)
- •- Patient aged 18 years and older
- •- ECOG (WHO) performance status 0-1
- •- Signed Informed Consent
- •- Patient beneficiary of a Social Security Insurance if applicable
- •During the selection period, any study related examination not required for the standard diagnosis must be performed after signature of the informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •- Patient with cerebral metastasis
- •- Patient with resectable or borderline non metastatic pancreatic adenocarcinoma
- •- Patient with known hypersensitivity to L-asparaginase or have had prior exposure to any form of L-asparaginase
- •- Anti-vitamin K treatment. Replacement with low molecular weight heparin treatment if required
- •- Patient unable to receive treatments based on gemcitabine or FOLFOX4 or ERY001, due to general or visceral conditions unrelated to pancreatic cancer such as:
- •* Bone marrow impairment as evidenced by hemoglobin < 9.0 g/dl, neutrophil count < 1.5 x 109/L, platelets < 100 x 109/L.
- •* Liver or pancreatic function abnormalities
- •AST or ALT > 3 x ULN, or
- •Total bilirubin > 1.5 x ULN, or
- •Lipase > 2N (grade 2) with suggestive clinical sign or > 3N without suggestive clinical sign
- •* Renal insufficiency: Renal clearance determined by the Cockroft and Gault Formula ? 60 mL/min
- •* Current or prior coagulopathy disorders
- •PT =1.5 fold the upper limit of normal value or
- •INR =1.5 fold the upper limit of normal value or
- •Fibrinogen = 0.75 fold the lower limit of normal value
- •* Infection: HIV, active hepatitis related to B or C virus
- •* Concurrent active malignancies (with the exception of in situ carcinoma of the cervix and inactive non melanoma skin cancer)
- •* Other serious conditions than pancreatic cancer according to investigator's opinion
- •* NYHA Grade = 2 congestive heart failure
- •- Systemic chemotherapy or radiation within the last 3 weeks or major surgery within 4 weeks
- •- History of grade 3 blood transfusion reaction (life threatening situation)
- •- Presence of rare and dangerous anti-erythrocyte antibodies preventing from getting a compatible packed Red Blood Cells for the patient
- •- Patient already included in another clinical trial, 30 days prior inclusion
- •- Women of child-bearing potential and men with partners of childbearing potential without effective contraception as well as pregnant or breast feeding women.
- •- Patients whose regular follow-up is impossible due to psychological, family, social or geographical reasons
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