NCT02195180已完成2 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 Pharma16 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2014年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 141
- 试验地点
- 16
- 主要终点
- Overall survival (OS)
研究概览
简要总结
A new approach that aims to destroy pancreatic tumor cells through modification of the tumor environment.
Asparagine synthetase (ASNS) is an enzyme wich synthetise asparagine. Asparagine is an essential nutriment for pancreatic cancer cells which have no or low level of ASNS.
by L-asparaginase encapsulated in erythrocytes deplete (supress) Plasma asparagine.
in selected patients having no or low ASNS, may provide a new therapeutic approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •A patient is eligible for the study if all of the following criteria are met:
- •Advanced or metastatic exocrine pancreatic adenocarcinoma, confirmed histologically
- •Available archival tumor tissue block with sufficient tissue either from primary tumor and/or from metastatic lesions for biomarker testing; alternatively, unstained slides with sufficient tissue may be substituted
- •Only 1 prior systemic therapy for advanced or metastatic disease. NOTE: Patient must be eligible to 2nd line gemcitabine or mFOLFOX6 treatment Documented disease progression during or following first-line therapy for advanced disease
- •Measurable lesion (>1cm) as assessed by CT scan or MRI (Magnetic Resonance Imaging) according to RECIST criteria (version 1.1)
- •Age 18 years and older
- •ECOG performance status 0 or 1
- •Ability to understand, and willingness to sign, a written informed consent and to comply with the scheduled visits, treatment plans, laboratory tests, and other study procedures.
- •Patient beneficiary of a Social Security Insurance if applicable
排除标准
- •A patient is excluded from the study if any of the following criteria are met:
- •Patient who have received Oxaliplatin in first line will not be eligible in FOLFOX arm; Patient who received Gemcitabine in first line will not be eligible in Gemcitabine arm
- •Resectable pancreatic adenocarcinoma
- •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
- •Inadequate organ functions:
- •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 > 2 x ULN with suggestive clinical sign of pancreatitis 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 in the last month
- •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
- •Known 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 NOTE: chemotherapy or radiation therapy given in less than 3 weeks is allowed, provided patient recovered from all related toxicities
- •History of grade 3 blood transfusion reaction (life threatening situation)
- •Presence of anti-erythrocyte antibodies (auto-antibodies or anti-public antibodies) preventing from getting a compatible packed Red Blood Cells for the patient
- •Participation in another concurrent clinical trial
- •Women of child-bearing potential and men with partners of childbearing potential without effective contraception as well as pregnant or breast feeding women
- •Other severe acute/chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the Investigator would make the patient inappropriate for entry into this study.
研究组 & 干预措施
standard of care combined with ERY001
Experimental
standard of care = Gemcitabine or folfox
干预措施: ERY001 (Drug)
standard of care combined with ERY001
Experimental
standard of care = Gemcitabine or folfox
干预措施: Gemcitabine (Drug)
standard of care combined with ERY001
Experimental
standard of care = Gemcitabine or folfox
干预措施: 5-fluoro-uracil/oxaliplatin/leucovorin (folfox) (Drug)
standard of care alone
Sham Comparator
standard of care = Gemcitabine or folfox
干预措施: Gemcitabine (Drug)
standard of care alone
Sham Comparator
standard of care = Gemcitabine or folfox
干预措施: 5-fluoro-uracil/oxaliplatin/leucovorin (folfox) (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: From last study treatment assessment visit until patient's death, loss to follow up, or study closure, assessed up to 36 months.
Evaluate the effects of eryaspase when combined with chemotherapy for the second line treatment of patients with pancreatic adenocarcinoma in terms of OS, whose tumors has low or no ASNS expression (ASNS 0 or 1+)
Progression free survival (PFS)
时间窗: From date of randomization to first documented progression of disease, death for any cause or until start of new anti-cancer treatment, whcihever came first, assessed up to 24 months.
Evaluate the effects of eryaspase when combined with chemotherapy for the second line treatment of patients with pancreatic adenocarcinoma in terms of PFS, whose tumors has low or no ASNS expression (ASNS 0 or 1+)
次要结局
- Objective response rate (ORR)(From date of randomization to last tumor assessment data collected for each patient, assessed up to 24 months.)
- Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)(collected from time of informed consent until 4 weeks after last study treatment)
- Overall survival(From last study treatment assessment visit until patient's death, loss to follow up, or study closure, assessed up to 36 months.)
- Progression free survival(From date of randomization to first documented progression of disease, death for any cause or until start of new anti-cancer treatment, whcihever came first, assessed up to 24 months.)
- Disease control rate (DCR)(From date of randomization to 16 and 24 weeks.)
- Duration of response (DoR)(From date of first response of complete or partial response until tumor progression, assessed up to 24 months.)
- Evaluate the relationship of clinical outcomes with tumor markers(From date of randomiztion to end of treatment visit, assessed up to 20 months.)
- Optical density reading(From date of randomization to first documented progression of disease, death for any cause or until start of new anti-cancer treatment, whcihever came first, assessed up to 24 months.)
- Quality of Life status(From date of randomiztion to end of treatment visit, assessed up to 20 months.)
研究者
研究点 (16)
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