EUCTR2018-000572-15-IT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 PHARMA S.A.0 个研究点目标入组 512 人开始时间: 2021年1月29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
- 512
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
- •1.Must be 18 years of age or older.
- •2.Must have histologically confirmed pancreatic adenocarcinoma.
- •3.Must have Stage III or IV disease (see Appendix 1).
- •4.Must have received only one line of systemic chemotherapy in advanced setting 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).
- •oMeasurable 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.
- •oBone 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 2 and 3):
- •oECOG Performance Status (PS) score of 0, or
- •oECOG PS score 1 and score =80 on Karnofsky Performance Status (KPS) scale.
- •NOTE: Must have body mass index (BMI) =18.5 kg/m2 (obtained <14 days prior to randomization
- •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.These include, but not limited to:
- •a. combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: i. intravaginal ii. transdermal
- •b. progestogen-only hormonal contraception associated with inhibition of ovulation: i. injectable ii. implantable
- •c. intrauterine device (IUD) d. bilateral tubal occlusion
- •e. vasectomised partner f. sexual abstinence (defined as refraining from heterosexual intercourse
- •during the entire period of risk associated with the study treatments) is intended. g. males with partners of childbearing potential must agree to use condoms
- •NOTE: Since an indirect interaction between components of the oral contraceptives and ASNase cannot be ruled out, oral contraceptives are
- •not considered acceptable as contraceptive methods in the current clinical trial. A method other than oral contraception should be used in women of childbearing potential. NOTE: All chemotherapeutic agents may be teratogenic and excreted in breast milk. Patients who are breast feeding should consider alternative
- •methods. Please refer to protocol for complete list
- •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 338
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 144
排除标准
- •1.Resectable or borderline resectable pancreatic adenocarcinom at the time of signing theinformed consent.
- •2.Histology other than pancreatic adenocarcinoma (for example, but not inclusive: neuroendocrine, adenosquamous, etc.).
- •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 high dose steroid treatment for at least 1 month prior to randomization.
- •6.Prior radiotherapy to the only area of measurable disease,
- •NOTE: Patients must have completed treatment and recovered from all acute treatment-related 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.
- •9ase including symptomatic congestive
研究者
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