Pancreatic AdenocarcinomaPhase 3Trybeca-1NCT03665441
Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment in PAC
A Phase 3 study testing eryaspase, Gemcitabine plus Abraxane and Irinotecan plus 5-FU plus leucovorin in people with Pancreatic Adenocarcinoma, run by ERYtech Pharma at 16 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- eryaspase, Gemcitabine plus Abraxane and Irinotecan plus 5-FU plus leucovorin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 512 participants
- Where
- 16 sitesin 3 countries
- Study dates
- 15 Sep 2018to 18 Jan 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- 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 during their participation in this trial while on study treatment. Patients taking part in surveys or observational studies are eligible to participate in this study.
- 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.
Who cannot join
- 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.
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- 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).
- Psychiatric illness/social situations or any other serious uncontrolled medical disorders in the opinion of the Investigator that would limit compliance with study requirements.
Trial locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
United States14 sites
Boca Raton Regional Hospital
Boca Raton, Florida, 33486
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Roswell Park Cancer Institute
Buffalo, New York, 14263
Duke University
Durham, North Carolina, 27705
St. Joseph Heritage Healthcare
Fullerton, California, 92835
University of Minnesota Health Clinics and Surgery Center
Minneapolis, Minnesota, 55455
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Weill Cornell Medicine
New York, New York, 10021
University of Rochester Medical Center
Rochester, New York, 14642
University of California Davis Medical Center
Sacramento, California, 95817
Arizona Cancer Center
Scottsdale, Arizona, 85258
Medical Oncology Associates
Spokane, Washington, 99208
Stony Brook University
Stony Brook, New York, 10021
Georgetown University Hospital
Washington D.C., District of Columbia, 20057
About this study
Official title: A Randomized, Phase 3 Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment of Patients With Pancreatic Adenocarcinoma
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.
Read the detailed description
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.
- Conditions
- Pancreatic Adenocarcinoma
- Being tested
- eryaspase, Gemcitabine plus Abraxane, Irinotecan plus 5-FU plus leucovorin
- Keywords
- pancreatic, cancer, asparaginase, gemcitabine, Abraxane, asparagine depletion, onivyde, nab-paclitaxel, folinic acid, fluorouracil, irinotecan, leucovorin, amino acid, RECIST 1.1
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eryaspaseDrug
Also called L-asparaginase
L-asparaginase encapsulated in erythrocytes (red blood cells)
Gemcitabine plus AbraxaneDrug
Also called Gemzar, nab-paclitaxel, onxol
gemcitabine, Abraxane
Irinotecan plus 5-FU plus leucovorinDrug
Also called Onivyde, liposomal irinotecan, Camptosar, Campto, Adrucil, Carac, Efudex, Efudix, folinic acid, calcium folinate
irinotecan, 5-FU, leucovorin
| Study group | Role | What they receive |
|---|---|---|
| Eryaspase plus Chemotherapy | Experimental | eryaspase 100 U/kg dosed every 2 weeks in combination with
Gemcitabine plus abraxane (albumin-bound paclitaxel) administered on Days 1, 8, and 15 of each 4 week cycle as follows:
* Abraxane (125 mg/m2) IV
* Gemcitabine (1000 mg/m2) IV
Or
Irinotecan plus 5-FU plus leucovorin administered on Days 1 and 15 of each 4 week cycle as follows:
* Onivyde 70 mg/m2 (irinotecan freebase) IV (recommended dose in patients homozygous for UGT1A1*28 is 50 mg/m2)
* Leucovorin 400 mg/m2 IV
* 5 FU 2400 mg/m2
Or
* FOLFIRI: Irinotecan 180 mg/m2 IV
* Leucovorin 400 mg/m² IV
* 5 FU 400 mg/m² IV bolus
* 5 FU 2400 mg/m² IV continuous infusion over 46 hours immediately following bolus 5 FU Receives: Drug: eryaspase; Drug: Gemcitabine plus Abraxane; Drug: Irinotecan plus 5-FU plus leucovorin |
| Chemotherapy alone | Other | Standard treatment: Gemcitabine plus abraxane (albumin-bound paclitaxel) administered on Days 1, 8, and 15 of each 4 week cycle Or Irinotecan plus 5-FU plus leucovorin administered on Days 1 and 15 of each 4 week cycle Receives: Drug: Gemcitabine plus Abraxane; Drug: Irinotecan plus 5-FU plus leucovorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
To determine whether the addition of eryaspase to chemotherapy improves OS when compared to chemotherapy alone
Measured: ~12 months
Secondary outcomes (6)
Progression Free Survival (PFS)
To compare PFS between the 2 treatment arm. Progression is determined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: ~24 weeks
Objective Response Rate (ORR)
To compare the ORR between the 2 treatment arms. ORR is defined as the proportion of patients who achieve objective tumor response (CR or PR) per modified RECIST 1.1: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.
Measured: ~24 weeks
Duration of Response (DoR)
To compare the DoR between the 2 treatment arms
Measured: ~24 weeks
Disease Control Rate (DCR)
To compare the between the 2 treatment arms
Measured: ~24 weeks
Incidence of Treatment Emergent Adverse Events as Assessed by CTCAE v5.0
To evaluate the safety and tolerability of eryaspase in combination with chemotherapy versus chemotherapy alone by assessing the number of patients with with treatment emergent adverse events per CTCAE v5.0
Measured: ~9 months
Time to Quality of Life Questionnaire EORTC QLQ-C30 First Worsening in Global Health Status Analysis
The time to first Worsening was defined as the date of randomization to the date of first Worsening occurred in patient score on their global health status. Patients who did not have any worsening were censored at date of last measurement or at baseline if no measurement is available post-baseline.
Measured: ~1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start15 Sep 2018
- Primary completion30 Aug 2021
- Study completion18 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 512 participants (actual)
Sponsor and investigators
- Lead sponsor
- ERYtech Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manuel Hidalgo, MD, PhD, Principal investigator, Weill Cornell, NY, USPascal Hammel, MD, PhD, Principal investigator, Hospital Beaujon, Clichy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665441
- Sponsor's protocol ID
- GRASPANC 2018-01
- Acronym
- Trybeca-1
- Status last verified
- Jan 2021
- First submitted
- 6 Sep 2018
- Last updated
- 18 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hammel P, Metges JP, Macarulla Mercade T, Garcia-Carbonero R, Bouche O, Portales F, Pazo Cid RA, Mineur L, Cubillo Gracian A, Trouilloud I, Guimbaud R, Tougeron D, Reina JJ, Feliu J, Sauri T, Fountzilas C, Lecomte T, Molin Y, Ponz-Sarvise M, Forget F, Berardi R, Van Cutsem E, Gelsomino F, Tournigand C, Bockorny B, Bachet JB, Marin Vera M, Cuyle PJ, Wasan H, Noel M, Van Laethem JL, Kay R, Youssoufian H, El-Hariry I, Hidalgo M. TRYBECA-1: A Randomized Phase III Study of Eryaspase Combined With Chemotherapy Versus Chemotherapy as Second-Line Treatment in Patients With Advanced Pancreatic Adenocarcinoma. J Clin Oncol. 2025 Dec 10;43(35):3714-3727. doi: 10.1200/JCO-25-00872. Epub 2025 Nov 4.
PubMed 41187298
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase 3 Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment of Patients With Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT03665441
- Acronym / sponsor ID
- Trybeca-1 / GRASPANC 2018-01
- Conditions
- Pancreatic Adenocarcinoma
- Keywords
- pancreatic, cancer, asparaginase, gemcitabine, Abraxane, asparagine depletion, onivyde, nab-paclitaxel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 512 participants (actual)
- Lead sponsor
- ERYtech PharmaIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 18 Jan 2022 (actual)
- First posted
- 11 Sep 2018 (actual)
- Results
- Posted 28 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eryaspase plus Chemotherapy | Experimental | Drug: eryaspase, Drug: Gemcitabine plus Abraxane, Drug: Irinotecan plus 5-FU plus leucovorineryaspase 100 U/kg dosed every 2 weeks in combination with Gemcitabine plus abraxane (albumin-bound paclitaxel) administered on Days 1, 8, and 15 of each 4 week cycle as follows: * Abraxane (125 mg/m2) IV * Gemcitabine (1000 mg/m2) IV Or Irinotecan plus 5-FU plus leucovorin administered on Days 1 and 15 of each 4 week cycle as follows: * Onivyde 70 mg/m2 (irinotecan freebase) IV (recommended dose in patients homozygous for UGT1A1*28 is 50 mg/m2) * Leucovorin 400 mg/m2 IV * 5 FU 2400 mg/m2 Or * FOLFIRI: Irinotecan 180 mg/m2 IV * Leucovorin 400 mg/m² IV * 5 FU 400 mg/m² IV bolus * 5 FU 2400 mg/m² IV continuous infusion over 46 hours immediately following bolus 5 FU |
| Chemotherapy alone | Other | Drug: Gemcitabine plus Abraxane, Drug: Irinotecan plus 5-FU plus leucovorinStandard treatment: Gemcitabine plus abraxane (albumin-bound paclitaxel) administered on Days 1, 8, and 15 of each 4 week cycle Or Irinotecan plus 5-FU plus leucovorin administered on Days 1 and 15 of each 4 week cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- 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.
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eryaspaseAlso: L-asparaginaseL-asparaginase encapsulated in erythrocytes (red blood cells) | Drug | Eryaspase plus Chemotherapy |
| Gemcitabine plus AbraxaneAlso: Gemzar, nab-paclitaxel, onxolgemcitabine, Abraxane | Drug | Chemotherapy alone, Eryaspase plus Chemotherapy |
| Irinotecan plus 5-FU plus leucovorinAlso: Onivyde, liposomal irinotecan, Camptosar, Campto, Adrucil, Carac, Efudex, Efudix, folinic acid, calcium folinateirinotecan, 5-FU, leucovorin | Drug | Chemotherapy alone, Eryaspase plus Chemotherapy |
Primary outcome
Overall Survival (OS)
Time frame: ~12 months
To determine whether the addition of eryaspase to chemotherapy improves OS when compared to chemotherapy alone
6 secondary outcomes
Progression Free Survival (PFS)
Time frame: ~24 weeks
Objective Response Rate (ORR)
Time frame: ~24 weeks
Duration of Response (DoR)
Time frame: ~24 weeks
Disease Control Rate (DCR)
Time frame: ~24 weeks
Incidence of Treatment Emergent Adverse Events as Assessed by CTCAE v5.0
Time frame: ~9 months
Time to Quality of Life Questionnaire EORTC QLQ-C30 First Worsening in Global Health Status Analysis
Time frame: ~1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41187298Hammel P, Metges JP, Macarulla Mercade T, Garcia-Carbonero R, Bouche O, Portales F, Pazo Cid RA, Mineur L, Cubillo Gracian A, Trouilloud I, Guimbaud R, Tougeron D, Reina JJ, Feliu J, Sauri T, Fountzilas C, Lecomte T, Molin Y, Ponz-Sarvise M, Forget F, Berardi R, Van Cutsem E, Gelsomino F, Tournigand C, Bockorny B, Bachet JB, Marin Vera M, Cuyle PJ, Wasan H, Noel M, Van Laethem JL, Kay R, Youssoufian H, El-Hariry I, Hidalgo M. TRYBECA-1: A Randomized Phase III Study of Eryaspase Combined With Chemotherapy Versus Chemotherapy as Second-Line Treatment in Patients With Advanced Pancreatic Adenocarcinoma. J Clin Oncol. 2025 Dec 10;43(35):3714-3727. doi: 10.1200/JCO-25-00872. Epub 2025 Nov 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel Hidalgo, MD, PhD principal investigator
Weill Cornell, NY, US
Pascal Hammel, MD, PhD principal investigator
Hospital Beaujon, Clichy, France
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing eryaspase, Gemcitabine plus Abraxane and Irinotecan plus 5-FU plus leucovorin in people with Pancreatic Adenocarcinoma, run by ERYtech Pharma at 16 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: ~12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03665441, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2022.