NL-OMON55526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 Adenocarcinoma - GRASPANC 2018-01
ERYTECH Pharma0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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 Protocol 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. NOTE: patients whose disease
- •progression on, or within 3 months, of neo(adjuvant) chemotherapy may be
- •considered eligible.
- •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. NOTE: if archival tissue is unavailable and an elective biopsy
- •can't be scheduled due to COVID, this will be waived
- •8. Must have adequate performance status (see Protocol Appendix 2 and 3):
- •- ECOG Performance Status (PS) score of 0, or
- •- ECOG score 1 and score >=80 on Karnofsky Performance Status (KPS) scale.
- •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. For more details see protocol
- •11. Must have adequate laboratory parameters at baseline (obtained <14 days
- •prior to randomization:Laboratory parameters outside of these ranges that are
- •deemed clinically insignificant should be discussed with the medical monitor
- •a. Absolute neutrophil count >=1.5 x 109/L.
- •b. Hemoglobin >=9 g/dL. monitorPatients with a baseline Hemoglobin >=13 g/dL
- •should be discussed with the medical monitor
- •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.
- 另有 2 项未显示
排除标准
- •1. Resectable or borderline resectable pancreatic adenocarcinoma at the time of
- •signing the informed consent
- •2. Histology other than pancreatic 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 high dose steroids 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 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.NOTE: Patients with unknown status of
- •hepatitis B or C must be tested and declared negative before randomization
- •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
- •unless they have previously tolerated full doses irinotecan . Subjects whose
- •UGT1A1 status is not known but are being considered for irinotecan-based
- •chemotherapy must be screened for UGT1A1*28 allele unless they have previously
- •tolerated full doses irinotecan before enrollment into the trial and must have
- •the initial irinotecan dose reduced if
- •demonstrated to be homozygous for the UGT1A1*28 allele.
- •NOTE: Patients assigned to the irinotecan/5 FU arms in the study should not
- •have dihydropyridine dehydrogenase deficiency (DPD). Patients whose DPD status
- •is unknown at time of screening should be tested before enrollment in the
- •irinotecan/5 FU arm unless they have previously tolerated full doses of 5 FU
- •13. Patients who have received live or live attenuated vaccines within 3 weeks
- •randomization.
- 另有 6 项未显示
研究者
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