EUCTR2018-000572-15-DK进行中（未招募）1 期
A Randomized, Phase 3 Study of Eryaspase in Combination with Chemotherapy versus Chemotherapy Alone as Second-Line Treatment in Patients with Pancreatic Adenocarcinoma - TRYbeCA-1– TRial of erYaspase in pancreatic CAncer
ERYTECH Pharma0 个研究点目标入组 602 人开始时间: 2018年8月27日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 602
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
入选标准
- •A patient will be eligible for the study if all the following criteria are met:
- •1. Must be 18 years of age or older.
- •2. Must have histologically confirmed pancreatic ductal adenocarcinoma.
- •3. Must have Stage III or IV disease (see Appendix 11.1).
- •4. Must have received only one line of systemic chemotherapy with or without targeted agents, immunotherapy, or radiotherapy for treatment of advanced pancreatic
- •adenocarcinoma.
- •5. Must have radiological evidence of disease progression following most recent prior treatment, defined as appearance of any new lesion or increase of >20% of one or more existing lesions.
- •6. Must have measurable lesion(s) per RECIST version 1.1 by CT scan with contrast (or MRI, if the patient is allergic to CT contrast media).
- •- Measurable disease may be in the field of prior irradiation; however, at least 4 weeks must have elapsed between the completion of radiation therapy and the baseline scan documenting disease status.
- •- Bone disease is considered radiologically measurable only if there is at least a 50% lytic component.
- •NOTE: Bone disease consisting of blastic lesion only is not measurable.
- •7. Archival or fresh tumor tissue must be available for evaluating relevant biomarkers. Formalin-fixed paraffin-embedded [FFPE] block preferred, or a minimum of 10 unstained FFPE slides of one archived block is required. NOTE: cytology samples
- •from fine needle aspirates or brushing biopsies are not sufficient.
- •8. Must have adequate performance status (see Appendix 11.2):
- •- ECOG Performance Status (PS) score of 0, or
- •- ECOG score 1 and score =80 on Karnofsky Performance Status (KPS) scale.
- •9. Must have life expectancy of >12 weeks according to the Investigator’s clinical judgment.
- •10. Females of childbearing potential must have a negative pregnancy test at screening and additional pregnancy test prior to first dose. Males and females of childbearing potential must agree to use a highly effective method of contraception during treatment and for at least 6 months after the last dose of study treatment.
- •11. Must have adequate laboratory parameters at baseline (obtained <14 days prior to randomization:
- •a. Absolute neutrophil count =1.5 x 109/L.
- •b. Hemoglobin =9 g/dL.
- •c. Platelet count =100,000/mm3 (100 x 109/L).
- •d. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =2.5 x upper limit of normal (ULN) (=5 x ULN in presence of liver metastases).
- •e. Total bilirubin =1.5 x institutional ULN.
- •f. Serum creatinine within normal limits or calculated clearance >60 mL/min/1.73 m2 for patients with serum creatinine levels above or below the
- •institutional normal range. Actual body weight should be used for calculating creatinine clearance (e.g., using the Cockcroft-Gault formula). For patients with a
- •Body Mass Index (BMI) >30 Kg/m2, lean body weight should be used instead.
- •g. Acceptable coagulation parameters: plasma antithrombin III >70%, fibrinogen =1.5 g/dL, international normalized ratio (INR) <1.5, and partial thromboplastin
- •time (PTT) =
排除标准
- •A patient is not eligible to participate in the study if any of the following criteria are met:
- •1. Resectable or borderline resectable pancreatic adenocarcinoma.
- •2. Histology other than pancreatic ductal adenocarcinoma (for example, but not inclusive: neuroendocrine, adenosquamous).
- •3. More than 1 line of prior treatment in advanced or metastatic setting.
- •4. Patient has experienced medically significant acute decline in clinical status including
- •a. Decline in ECOG PS to >1 (or KPS <70) between baseline visit and within 72 hours prior to randomization.
- •b. Weight loss of =10% during screening.
- •5. Presence of active or symptomatic untreated central nervous system (CNS) metastases.
- •NOTE: Patients with asymptomatic or stable CNS metastases are eligible, provided that the CNS metastases are radiologically and clinically stable, and the patient is off steroids for at least 1 month prior to randomization.
- •6. Prior radiotherapy to the only area of measurable disease, unless there is documented disease progression, defined as an increase of at least 1 cm in the longest diameter compared to the nadir scan.
- •NOTE: Patients must have completed treatment and recovered from all acute treatmentrelated toxicities prior to administration of the first dose of eryaspase or chemotherapy.
- •7. Bone as the only site of metastatic disease from pancreatic cancer (bone-only disease).
- •8. History of recent clinical pancreatitis, according to revised Atlanta criteria, within 3 months of randomization.
- •NOTE: The revised Atlanta classification [1] requires that two or more of the following criteria be met for the diagnosis of acute pancreatitis: (a) abdominal pain suggestive of
- •pancreatitis, (b) serum amylase or lipase level =3 x ULN, or (c) characteristic imaging findings using CT or MRI.
- •9. Neurosensory neuropathy >Grade 1 at baseline.
- •10. Pregnancy or breastfeeding.
- •11. History of infection with human immunodeficiency virus (HIV) and/or active infection with hepatitis B or hepatitis C.
- •12. Hypersensitivity to any of the components of the chemotherapy or asparaginase.
- •NOTE: Patients known to be homozygous for UGT1A1*28 who are assigned to an irinotecan-containing regimen must have the initial irinotecan dose reduced. Subjects whose UGT1A1 status is not known but are being considered for irinotecan-based
- •chemotherapy must be screened for UGT1A1*28 allele before enrollment into the trial and must have the initial irinotecan dose reduced if demonstrated to be homozygous for the UGT1A1*28 allele.
- •13. Patients being treated with warfarin are not eligible. Warfarin must be replaced with low molecular weight heparin.
- •14. History of other malignancies except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated by
- •surgery alone or surgery plus radiotherapy with no evidence of disease for >5 years.
- •15. Any other severe acute or chronic condition that may increase the risk of study participation including:
- •a. History of abdominal fistula, gastrointestinal perforat
研究者
相似试验
已完成
3 期
A Randomized, Phase 3 Study of Eryaspase in Combination with Chemotherapy versus Chemotherapy Alone as Second-Line Treatment in Patients with Pancreatic AdenocarcinomaPancreatic Adenocarcinoma10017991Pancreatic cancerNL-OMON55526ERYTECH Pharma10
进行中（未招募）
1 期
Clinical study in subjects with pancreatic adenocarcinoma to assess safety and efficacy of investigational product (eryaspase) when added to standard chemotherapyPancreatic AdenocarcinomaMedDRA version: 21.1Level: LLTClassification code 10051971Term: Pancreatic adenocarcinomaSystem Organ Class: 100000004864EUCTR2018-000572-15-ATERYTECH Pharma482
进行中（未招募）
1 期
Clinical study in subjects with pancreatic adenocarcinoma to assess safety and efficacy of investigational product (eryaspase) when added to standard chemotherapyEUCTR2018-000572-15-BEERYTECH Pharma482
进行中（未招募）
1 期
Clinical study in subjects with pancreatic adenocarcinoma to assess safety and efficacy of investigational product (eryaspase) when added to standard chemotherapyEUCTR2018-000572-15-FIERYTECH Pharma482
进行中（未招募）
1 期
Clinical study in subjects with pancreatic adenocarcinoma to assess safety and efficacy of investigational product (eryaspase) when added to standard chemotherapyPancreatic AdenocarcinomaMedDRA version: 21.1Level: LLTClassification code 10051971Term: Pancreatic adenocarcinomaSystem Organ Class: 100000004864EUCTR2018-000572-15-SEERYTECH Pharma482