Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment in PAC

Completed · Phase 3

Conditions studied: Pancreatic Adenocarcinoma

In brief

This is an open-label, multicenter, randomized, Phase 3 study in patients with ductal adenocarcinoma of the pancreas who have failed only one prior line of systemic anti-cancer therapy for advanced pancreatic cancer and have measurable disease.

Key facts

Study ID

NCT03665441

Run by

ERYtech Pharma

People needed

512

Starts

2018-09-15

Expected to finish

2022-01-18

Last updated by the study team

2022-10-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A patient will be eligible for the study if all the following criteria are met:
• Must be 18 years of age or older.
• Must have histologically confirmed pancreatic adenocarcinoma.
• Must have Stage III or IV disease.
• Must have received one line of systemic chemotherapy in the advanced setting with or without targeted agents, immunotherapy, or radiotherapy for treatment of advanced pancreatic adenocarcinoma.
• 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.
• 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).
• NOTE: Bone disease consisting of blastic lesion only is not measurable.
• 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.
• If archival tissue is unavailable and an elective biopsy can't be scheduled due to COVID, this will be waived.
• Must have adequate performance status:
• ECOG Performance Status (PS) score of 0, or
• ECOG PS score one 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.
• Must have life expectancy of >12 weeks according to the investigator's clinical judgment.
• Females of childbearing potential must have a negative pregnancy test at screening and additional negative 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.
• 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:
• Absolute neutrophil count ≥1.5 x 109/L.
• Hemoglobin ≥9 g/dL. Patients with a baseline Hemoglobin ≥13 g/dL should be discussed with the medical monitor.
• Platelet count ≥100,000/mm3 (100 x 109/L).
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x upper limit of normal (ULN) (≤5 x ULN in presence of liver metastases).
• Total bilirubin ≤ 1.5 x institutional ULN.
• 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.
• Acceptable coagulation parameters: plasma antithrombin III >70% and fibrinogen ≥1.5 g/L
• Serum albumin ≥3.0 g/dL.

You may not qualify if…

• A patient is not eligible to participate in the study if any of the following criteria are met:
• Resectable or borderline resectable pancreatic adenocarcinoma at the time of signing the informed consent.
• Histology other than pancreatic adenocarcinoma (for example, but not inclusive: neuroendocrine, adenosquamous, etc.).
• More than one line of prior treatment in advanced or metastatic setting.
• Patient has experienced medically significant acute decline in clinical status including
• Decline in ECOG PS to >1 (or KPS <70) between baseline visit and within 72 hours prior to randomization.
• Weight loss of ≥10% during screening.
• 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 one month prior to randomization.
• 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.
• Bone as the only site of metastatic disease from pancreatic cancer (bone only disease).
• 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.
• Neurosensory neuropathy > Grade 2 at baseline.
• Pregnancy or breastfeeding.
• 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.
• Hypersensitivity to any of the components of the chemotherapy or ASNase.
• Patients who have received live or live attenuated vaccines within 3 weeks of randomization.
• History of other malignancies NOTE: Adequately treated non-melanoma skin cancer or curatively treated in-situ cancer of the cervix may be eligible.
• NOTE: Patients successfully treated for other malignancies and are disease-free for at least 5 years may be eligible.
• Any other severe acute or chronic condition/treatments that may increase the risk of study participation including:
• History of abdominal fistula, gastrointestinal perforation, peptic ulcer, or intra-abdominal abscess within 6 months prior to randomization.
• Current or history within 6 months prior to randomization of medically significant cardiovascular disease including symptomatic congestive heart failure >New York Heart Association (NYHA) Class II, unstable angina pectoris, clinically significant cardiac arrhythmia.
• Patients with pre-existing coagulopathy (e.g. hemophilia).

Where it is running

• Arizona Cancer Center — Scottsdale, Arizona, United States
• St. Joseph Heritage Healthcare — Fullerton, California, United States
• University of California Davis Medical Center — Sacramento, California, United States
• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Boca Raton Regional Hospital — Boca Raton, Florida, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Minnesota Health Clinics and Surgery Center — Minneapolis, Minnesota, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Weill Cornell Medicine — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Stony Brook University — Stony Brook, New York, United States
• Duke University — Durham, North Carolina, United States
• Medical Oncology Associates — Spokane, Washington, United States
• Institut de Cancerologie — Brest, France
• Hammersmith Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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