Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment in PDAC
- Must be 18 years of age or older.
- Must have histologically confirmed pancreatic ductal adenocarcinoma.
- Must have Stage III or IV disease.
- Must have received only one line of systemic chemotherapy 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.
- Must have measurable lesion(s).
- Archival or fresh tumor tissue must be available for evaluating relevant biomarkers.
- Must have adequate performance status: ECOG score of 0 or 1.
- 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 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 hematologic, chemistry and coagulation laboratory parameters at baseline.
- Patients requiring biliary stent placement must have the biliary stent placed >7 days prior to screening and must have normalization of bilirubin level after stenting.
- Must not be receiving therapy in a concurrent clinical study and must agree not to participate in any other interventional clinical studies.
- Must be able to understand and comply with the conditions of the protocol and must have read and understood the consent form and provided written informed consent.
- Resectable or borderline resectable pancreatic adenocarcinoma.
- Patient has experienced medically significant acute decline in clinical status including
- Decline in ECOG PS to >1 (or KPS <70)
- Weight loss of ≥10% during screening.
- Presence of active or symptomatic untreated central nervous system (CNS) metastases.
- Prior radiotherapy to the only area of measurable disease.
- Bone as the only site of metastatic disease from pancreatic cancer.
- History of recent clinical pancreatitis.
- Neurosensory neuropathy >Grade 1 at baseline.
- Pregnancy or breastfeeding.
- History of infection with human immunodeficiency virus (HIV) and/or active infection with hepatitis B or hepatitis C.
- Hypersensitivity to any of the components of the chemotherapy or asparaginase.
- Patients being treated with warfarin are not eligible. Warfarin must be replaced with low molecular weight heparin.
- 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.
- Any other severe acute or chronic condition that may increase the risk of study participation.
Patients who meet all inclusion and exclusion criteria will be randomized in a 1:1 ratio to one of the following treatment arms (see figure below): - Arm A (investigational arm): eryaspase in combination with either gemcitabine/Abraxane or irinotecan-based therapy (FOLFIRI [FOLinic acid-Fluorouracil-IRInotecan regimen] or Onivyde®/5 fluorouracil/leucovorin), or - Arm B (control arm): gemcitabine/Abraxane or irinotecan-based therapy (FOLFIRI or Onivyde/5-FU/leucovorin) The chemotherapy will be investigator's choice and based on what patient has received in first line treatment. Treatment will continue until disease progression, unacceptable toxicity, or the patient's withdrawal of consent. An End of Treatment visit should occur within approximately 30 days from last dose of eryaspase or chemotherapy regimen. A survival follow-up period will include the collection of survival, progression of disease if applicable, treatment updates, and quality of life assessments every 8 weeks.
Trial Phase Phase III
Trial Type Treatment
- Primary ID GRASPANC 2018-01
- Secondary IDs NCI-2019-03830
- Clinicaltrials.gov ID NCT03665441