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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

Clinical Trial Details

Eryaspase is an investigational drug. The term “investigation” refers to any drug or device that is being tested and is not approved for sale by the United States Food and Drug Administration (the FDA) for your disease. This means that Eryaspase can only be used for research. Eryaspase is made up of red blood cells that have been changed, and a particular enzyme was put inside it. This enzyme removes an essential nutrient (protein/amino acid) from the bloodstream that cancer cells depend on for life and growth. As a result, cancer cells may “starve” or die. Eryaspase has been tested previously in approximately 307 patients. About 104 of these subjects were treated for pancreatic cancer in 2 other clinical trials. The results of those 2 small clinical trials were positive, but additional testing must be done. 

In this study the experimental drug, eryaspase, will be given with chemotherapy which is already approved or used to treat patients with pancreatic cancer (either gemcitabine + Abraxane, or an irinotecan based regimen, for example irinotecan plus 5-fluorouracil [5-FU] and leucovorin). The purpose of this study is to find out if giving eryaspase with the chemotherapy works better than giving the chemotherapy by itself.

Subjects who participate will either receive the experimental drug, eryaspase, plus chemotherapy or chemotherapy only. Subjects who participate in this study will have already received prior treatment for advanced pancreatic cancer, and their cancer has continued to grow or has become worse.

Key Eligibility: 
  • 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 advanced setting with or without targeted agents, immunotherapy, or radiotherapy for treatment of advanced pancreatic adenocarcinoma

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

June Greenberg, RN
(212) 746-2651
jdg2002@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2001021298

ClinicalTrials.gov:

NCT03665441

Sponsor:

GRASPANC 2018-01

Status

Open to Enrollment

Age Group

Adult

Sponsor