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Enzyme
Eryaspase + Modified FOLFIRINOX for Pancreatic Cancer
Phase 1
Waitlist Available
Led By Marcus S Noel, MD
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must be > 18 years of age
Patient must have histologically or cytologically confirmed pancreatic adenocarcinoma, which is locally advanced, unresectable, or metastatic
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to treat pancreatic cancer. The standard 3+3 design will be used to determine the maximum tolerated dose (MTD) from 4 possible dose levels of Eryaspase in combination with mFOLFIRINOX.
Who is the study for?
This trial is for adults over 18 with advanced pancreatic adenocarcinoma who haven't had surgery, chemo, or radiotherapy for their metastatic disease. They must have normal organ and bone marrow function, measurable disease by RECIST 1.1 criteria, a life expectancy of at least 3 months, and an ECOG performance status ≤ 1. Women of childbearing potential must test negative for pregnancy and agree to use contraception.Check my eligibility
What is being tested?
The study tests the safety and early effectiveness of adding Eryaspase to modified FOLFIRINOX (a combination chemotherapy) in patients with advanced pancreatic cancer using a standard '3+3' design to find the highest dose that's safe (MTD). Participants will undergo various safety assessments including monitoring adverse events and regular physical exams.See study design
What are the potential side effects?
Potential side effects include reactions related to asparaginase such as allergic responses; chemotherapy-related issues like nausea, vomiting, diarrhea; blood count changes; fatigue; liver enzyme alterations; risk of infection due to immune system suppression from both the cancer and treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
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My pancreatic cancer is advanced and cannot be removed by surgery.
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I haven't had surgery, chemo, radiotherapy, or trial treatments for my advanced cancer.
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I am fully active and can carry on all my pre-disease activities without restriction.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Grade 3 or 4 adverse events
Secondary outcome measures
Objective Response Rate
overall survival (OS)
progression-free survival (PFS)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Eryaspase plus FOLFIRINOXExperimental Treatment2 Interventions
Eryaspase will be administered on day 1 and 15 of a 4 week cycle (intravenous infusion) in dose escalating/reduction depending on the cohort the patient is assigned to
mFOLFIRINOX dosing will include 5-fluorouracil 2400 mg/m² over 46 hours, oxaliplatin 85 mg/m², Irinotecan 150 mg/m² (intravenous infusion) on Day 1 and 15 of the 4 weeks cycle for a maximum of 12 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leucovorin
FDA approved
Find a Location
Who is running the clinical trial?
Georgetown UniversityLead Sponsor
343 Previous Clinical Trials
136,483 Total Patients Enrolled
ERYtech PharmaIndustry Sponsor
11 Previous Clinical Trials
1,024 Total Patients Enrolled
Marcus S Noel, MDPrincipal InvestigatorGeorgetown University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My bone marrow and organs are functioning normally.I have received a transplant from another person.I have not received a live vaccine within 30 days before starting the study medication, except for the seasonal flu shot.I am HIV-positive and on antiretroviral therapy.I am older than 18 years.I agree to use two forms of birth control if my partner can have children.My kidney function is normal or near normal.I have had cancer other than skin or early-stage cervical/breast cancer in the last 3 years.You cannot have taken any experimental drugs within the last 28 days before the screening.My cancer is a type of neuroendocrine, duodenal, or ampullary adenocarcinoma.My pancreatic cancer is advanced and cannot be removed by surgery.My cancer returned or got worse more than 6 months after finishing initial treatment.I do not have brain metastases.I am of childbearing age and have a negative pregnancy test.I haven't had surgery, chemo, radiotherapy, or trial treatments for my advanced cancer.I am allergic to certain cancer drugs like asparaginase or oxaliplatin.I have an autoimmune disease but it's not vitiligo or resolved childhood asthma.I do not have any severe ongoing illnesses that could interfere with the study.I am fully active and can carry on all my pre-disease activities without restriction.
Research Study Groups:
This trial has the following groups:- Group 1: Eryaspase plus FOLFIRINOX
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How does the risk profile of Eryaspase compare to other treatments?
"The safety of Eryaspase was evaluated as a 1, due to the limited evidence available from this phase one trial."
Answered by AI
How many participants can partake in this trial at its peak?
"At this moment, this clinical trial is not actively seeking participants. The post was originally published on December 2nd 2020 and last updated August 3rd 2022. In the meantime, there are plenty of other relevant studies recruiting; for adenocarcinoma, 771 trials are open to applicants and 643 for Eryaspase."
Answered by AI
Are researchers still signing up participants for this clinical investigation?
"The data available on clinicaltrials.gov reveals that this medical trial is not presently accepting applicants, considering it was last amended on August 3rd 2022 and initially posted two years prior. Nevertheless, there are 1,414 other studies enrolling patients at the present time."
Answered by AI
What medical maladies does Eryaspase typically remedy?
"Malignant growths in the rectum and colon, as well as ovarian cancer can be ameliorated with Eryaspase."
Answered by AI
What prior studies have involved the use of Eryaspase?
"Currently, there are 201 Phase 3 investigations into the effectiveness of Eryaspase being conducted. Predominantly in Guangzhou, Guangdong Province, these studies span a total of 27590 locations worldwide."
Answered by AI
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