Pancreatic Adenocarcinoma MetastaticPhase 2NCT02195180
Efficacy and Safety of L-asparaginase Encapsulated in RBC Combined With Gemcitabine or FOLFOX in 2nd Line for Progressive Metastatic Pancreatic Carcinoma
A Phase 2 study testing ERY001, Gemcitabine and 5-fluoro-uracil/oxaliplatin/leucovorin (folfox) in people with Pancreatic Adenocarcinoma Metastatic, run by ERYtech Pharma at 16 sites in France.
Trial summary
A new approach that aims to destroy pancreatic tumor cells through modification of the tumor environment. Asparagine synthetase (ASNS) is an enzyme wich synthetise asparagine. Asparagine is an essential nutriment for pancreatic cancer cells which have no or low level of ASNS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma Metastatic
- What is being tested?
- ERY001, Gemcitabine and 5-fluoro-uracil/oxaliplatin/leucovorin (folfox)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 141 participants
- Where
- 16 sitesFrance
- Study dates
- Jul 2014to Nov 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 is eligible for the study if all of the following criteria are met:
- Advanced or metastatic exocrine pancreatic adenocarcinoma, confirmed histologically
- Available archival tumor tissue block with sufficient tissue either from primary tumor and/or from metastatic lesions for biomarker testing; alternatively, unstained slides with sufficient tissue may be substituted
- Only 1 prior systemic therapy for advanced or metastatic disease. NOTE: Patient must be eligible to 2nd line gemcitabine or mFOLFOX6 treatment Documented disease progression during or following first-line therapy for advanced disease
- Measurable lesion (>1cm) as assessed by CT scan or MRI (Magnetic Resonance Imaging) according to RECIST criteria (version 1.1)
- Age 18 years and older
Show all 9Show fewer
- ECOG performance status 0 or 1
- Ability to understand, and willingness to sign, a written informed consent and to comply with the scheduled visits, treatment plans, laboratory tests, and other study procedures.
- Patient beneficiary of a Social Security Insurance if applicable
Who cannot join
- A patient is excluded from the study if any of the following criteria are met:
- Patient who have received Oxaliplatin in first line will not be eligible in FOLFOX arm; Patient who received Gemcitabine in first line will not be eligible in Gemcitabine arm
- Resectable pancreatic adenocarcinoma
- Known hypersensitivity to L-asparaginase or have had prior exposure to any form of L-asparaginase
- Anti-vitamin K treatment. Replacement with low molecular weight heparin treatment if required
- Inadequate organ functions:
Show all 26Show fewer
- hemoglobin < 9.0 g/dl, neutrophil count < 1.5 x 109/L, platelets < 100 x 109/L.
- Liver or pancreatic function abnormalities
- AST or ALT > 3 x ULN, or
- Total bilirubin > 1.5 x ULN, or
- Lipase > 2 x ULN with suggestive clinical sign of pancreatitis or > 3N without suggestive clinical sign
- Renal insufficiency: Renal clearance determined by the Cockroft and Gault Formula < 60 mL/min
- Current or prior coagulopathy disorders in the last month
- PT ≥1.5 fold the upper limit of normal value or
- INR ≥1.5 fold the upper limit of normal value or
- Fibrinogen ≤ 0.75 fold the lower limit of normal value
- Known Infection: HIV, active hepatitis related to B or C virus
- Concurrent active malignancies (with the exception of in situ carcinoma of the cervix and inactive non melanoma skin cancer
- Other serious conditions than pancreatic cancer according to investigator's opinion
- NYHA Grade ≥ 2 congestive heart failure
- Systemic chemotherapy or radiation within the last 3 weeks or major surgery within 4 weeks NOTE: chemotherapy or radiation therapy given in less than 3 weeks is allowed, provided patient recovered from all related toxicities
- History of grade 3 blood transfusion reaction (life threatening situation)
- Presence of anti-erythrocyte antibodies (auto-antibodies or anti-public antibodies) preventing from getting a compatible packed Red Blood Cells for the patient
- Participation in another concurrent clinical trial
- Women of child-bearing potential and men with partners of childbearing potential without effective contraception as well as pregnant or breast feeding women
- Other severe acute/chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the Investigator would make the patient inappropriate for entry into this study.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
Saint Catherine Institute
Avignon, 84918
Institut de Cancerologie
Brest, 29609
Hopital Beaujon
Clichy, 92118
Hospital Henri Mondor
Créteil, 94010
Groupe Hospitalier Mutualiste Grenoble
Grenoble, 38028
Centre Hospitalier Departemental Vendee - Les Oudairies
La Roche-sur-Yon, 85925
Centre Oscar Lambret
Lille, 59020
Cnetre Leon Berard
Lyon, 69373
Institut Regional du Cancer-Montpellier Val d'Aurelle
Montpellier, 34298
Institute Mutualiste Montsouris
Paris, 75014
Hospital Saint Antoine
Paris, 75571
Hospital Pitie Salpetriere
Paris, 75651
CHU de Poitiers
Poitiers, 42109
CHU Reims
Reims, 51100
CHU Toulouse - Rangueil
Toulouse, 31059
CHU de Tours
Tours, 37044
About this study
Official title: Phase II, Randomized, Controlled, Clinical Trial Exploring Efficacy and Safety of ERY001 (L-asparaginase Encapsulated in Red Blood Cells) in Association With Gemcitabine or FOLFOX4 in Second-line Therapy for Patients With Progressive Metastatic Pancreatic Carcinoma
A new approach that aims to destroy pancreatic tumor cells through modification of the tumor environment.
Asparagine synthetase (ASNS) is an enzyme wich synthetise asparagine. Asparagine is an essential nutriment for pancreatic cancer cells which have no or low level of ASNS.
by L-asparaginase encapsulated in erythrocytes deplete (supress) Plasma asparagine.
in selected patients having no or low ASNS, may provide a new therapeutic approach.
- Conditions
- Pancreatic Adenocarcinoma Metastatic
- Being tested
- ERY001, Gemcitabine, 5-fluoro-uracil/oxaliplatin/leucovorin (folfox)
- Keywords
- Pancreas, adenocarcinoma, cancer, asparaginase, erythrocytes, red blood cell, Encapsulation, folfox, gemcitabine
- Medical subject headings
- Adenocarcinoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERY001Drug
Also called L asparaginase encapsulated in erythrocytes
GemcitabineDrug
5-fluoro-uracil/oxaliplatin/leucovorin (folfox)Drug
oxaliplatin 85 mg/m2 levo-leucovorin 200 mg/m2 5-FU 400 mg/m2
| Study group | Role | What they receive |
|---|---|---|
| standard of care combined with ERY001 | Experimental | standard of care = Gemcitabine or folfox Receives: Drug: ERY001; Drug: Gemcitabine; Drug: 5-fluoro-uracil/oxaliplatin/leucovorin (folfox) |
| standard of care alone | Sham comparator | standard of care = Gemcitabine or folfox Receives: Drug: Gemcitabine; Drug: 5-fluoro-uracil/oxaliplatin/leucovorin (folfox) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Evaluate the effects of eryaspase when combined with chemotherapy for the second line treatment of patients with pancreatic adenocarcinoma in terms of OS, whose tumors has low or no ASNS expression (ASNS 0 or 1+)
Measured: From last study treatment assessment visit until patient's death, loss to follow up, or study closure, assessed up to 36 months.
Progression free survival (PFS)
Evaluate the effects of eryaspase when combined with chemotherapy for the second line treatment of patients with pancreatic adenocarcinoma in terms of PFS, whose tumors has low or no ASNS expression (ASNS 0 or 1+)
Measured: From date of randomization to first documented progression of disease, death for any cause or until start of new anti-cancer treatment, whcihever came first, assessed up to 24 months.
Secondary outcomes (9)
Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)
Compare the safety profile in patients treated with eryaspase in combination with chemotherapy versus chemotherapy alone, including adverse events, vital signs and clinical laboratory assessments
Measured: collected from time of informed consent until 4 weeks after last study treatment
Overall survival
Evaluate the effects of eryaspase in combination with chemotherapy on investigator-assessed OS in all randomized patients (all patients) and in patients with ASNS 2+/3+ expressing tumors.
Measured: From last study treatment assessment visit until patient's death, loss to follow up, or study closure, assessed up to 36 months.
Progression free survival
Evaluate the effects of eryaspase in combination with chemotherapy on investigator-assessed PFS in all randomized patients (all patients) and in patients with ASNS 2+/3+ expressing tumors.
Measured: From date of randomization to first documented progression of disease, death for any cause or until start of new anti-cancer treatment, whcihever came first, assessed up to 24 months.
Objective response rate (ORR)
Evaluate the effect of eryaspase in combination with chemotherapy on the ORR, and the duration in all comers, patients with ASNS 0/1+ expressing tumors, and those with ASNS 2+/3+ expressing tumors.
Measured: From date of randomization to last tumor assessment data collected for each patient, assessed up to 24 months.
Disease control rate (DCR)
Evaluate the effect of eryaspase in combination with chemotherapy on the DCR in all comers, patients with ASNS 0/1+ expressing tumors, and those with ASNS 2+/3+ expressing tumors.
Measured: From date of randomization to 16 and 24 weeks.
Duration of response (DoR)
Evaluate the effect of eryaspase in combination with chemotherapy on the DoR in all comers, patients with ASNS 0/1+ expressing tumors, and those with ASNS 2+/3+ expressing tumors.
Measured: From date of first response of complete or partial response until tumor progression, assessed up to 24 months.
Evaluate the relationship of clinical outcomes with tumor markers
Evaluate the relationship of clinical outcome (i.e. OS, PFS, ORR, DCR and DoR) with tumor markers, namely cancer antigen (CA19-9), and carcinoembryonic antigen test (CEA).
Measured: From date of randomiztion to end of treatment visit, assessed up to 20 months.
Optical density reading
Assess the effect of eryaspase in combination with chemotherapy on PFS, OS, ORR, BOR, and other clinical outcomes in ASNS subsets, as determined by optical density reading.
Measured: From date of randomization to first documented progression of disease, death for any cause or until start of new anti-cancer treatment, whcihever came first, assessed up to 24 months.
Quality of Life status
Compare the 2 treatment arms with respect to change in quality of life status, the change of QOL relative to baseline
Measured: From date of randomiztion to end of treatment visit, assessed up to 20 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionFeb 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Adenocarcinoma MetastaticStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- ERYtech Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pascal Hammel, Pr MD, Principal investigator, Hopital Beaujon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02195180
- Sponsor's protocol ID
- GRASPANC 2013-03
- Other IDs
- 2013-004262-34
- Status last verified
- Nov 2017
- First submitted
- 16 Jul 2014
- Last updated
- 27 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bachet JB, Blons H, Hammel P, Hariry IE, Portales F, Mineur L, Metges JP, Mulot C, Bourreau C, Cain J, Cros J, Laurent-Puig P. Circulating Tumor DNA is Prognostic and Potentially Predictive of Eryaspase Efficacy in Second-line in Patients with Advanced Pancreatic Adenocarcinoma. Clin Cancer Res. 2020 Oct 1;26(19):5208-5216. doi: 10.1158/1078-0432.CCR-20-0950. Epub 2020 Jun 30.
PubMed 32605910Hammel P, Fabienne P, Mineur L, Metges JP, Andre T, De La Fouchardiere C, Louvet C, El Hajbi F, Faroux R, Guimbaud R, Tougeron D, Bouche O, Lecomte T, Rebischung C, Tournigand C, Cros J, Kay R, Hamm A, Gupta A, Bachet JB, El Hariry I. Erythrocyte-encapsulated asparaginase (eryaspase) combined with chemotherapy in second-line treatment of advanced pancreatic cancer: An open-label, randomized Phase IIb trial. Eur J Cancer. 2020 Jan;124:91-101. doi: 10.1016/j.ejca.2019.10.020. Epub 2019 Nov 21.
PubMed 31760314
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Randomized, Controlled, Clinical Trial Exploring Efficacy and Safety of ERY001 (L-asparaginase Encapsulated in Red Blood Cells) in Association With Gemcitabine or FOLFOX4 in Second-line Therapy for Patients With Progressive Metastatic Pancreatic Carcinoma
- ClinicalTrials.gov ID
- NCT02195180
- Acronym / sponsor ID
- GRASPANC 2013-03
- Conditions
- Pancreatic Adenocarcinoma Metastatic
- Keywords
- Pancreas, adenocarcinoma, cancer, asparaginase, erythrocytes, red blood cell, Encapsulation, folfox
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- ERYtech PharmaIndustry (pharma, biotech, devices)
- Study start
- Jul 2014 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 21 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A new approach that aims to destroy pancreatic tumor cells through modification of the tumor environment.
Asparagine synthetase (ASNS) is an enzyme wich synthetise asparagine. Asparagine is an essential nutriment for pancreatic cancer cells which have no or low level of ASNS.
by L-asparaginase encapsulated in erythrocytes deplete (supress) Plasma asparagine.
in selected patients having no or low ASNS, may provide a new therapeutic approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard of care combined with ERY001 | Experimental | Drug: ERY001, Drug: Gemcitabine, Drug: 5-fluoro-uracil/oxaliplatin/leucovorin (folfox)standard of care = Gemcitabine or folfox |
| standard of care alone | Sham comparator | Drug: Gemcitabine, Drug: 5-fluoro-uracil/oxaliplatin/leucovorin (folfox)standard of care = Gemcitabine or folfox |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Advanced or metastatic exocrine pancreatic adenocarcinoma, confirmed histologically
- Available archival tumor tissue block with sufficient tissue either from primary tumor and/or from metastatic lesions for biomarker testing; alternatively, unstained slides with sufficient tissue may be substituted
- Only 1 prior systemic therapy for advanced or metastatic disease. NOTE: Patient must be eligible to 2nd line gemcitabine or mFOLFOX6 treatment Documented disease progression during or following first-line therapy for advanced disease
- Measurable lesion (>1cm) as assessed by CT scan or MRI (Magnetic Resonance Imaging) according to RECIST criteria (version 1.1)
- Age 18 years and older
Key exclusion criteria (26 listed)
- Patient who have received Oxaliplatin in first line will not be eligible in FOLFOX arm; Patient who received Gemcitabine in first line will not be eligible in Gemcitabine arm
- Resectable pancreatic adenocarcinoma
- Known hypersensitivity to L-asparaginase or have had prior exposure to any form of L-asparaginase
- Anti-vitamin K treatment. Replacement with low molecular weight heparin treatment if required
- Inadequate organ functions:
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 |
|---|---|---|
| ERY001Also: L asparaginase encapsulated in erythrocytes | Drug | standard of care combined with ERY001 |
| Gemcitabine | Drug | standard of care alone, standard of care combined with ERY001 |
| 5-fluoro-uracil/oxaliplatin/leucovorin (folfox)oxaliplatin 85 mg/m2 levo-leucovorin 200 mg/m2 5-FU 400 mg/m2 | Drug | standard of care alone, standard of care combined with ERY001 |
Primary outcome
Overall survival (OS)
Time frame: From last study treatment assessment visit until patient's death, loss to follow up, or study closure, assessed up to 36 months.
Evaluate the effects of eryaspase when combined with chemotherapy for the second line treatment of patients with pancreatic adenocarcinoma in terms of OS, whose tumors has low or no ASNS expression (ASNS 0 or 1+)
Progression free survival (PFS)
Time frame: From date of randomization to first documented progression of disease, death for any cause or until start of new anti-cancer treatment, whcihever came first, assessed up to 24 months.
Evaluate the effects of eryaspase when combined with chemotherapy for the second line treatment of patients with pancreatic adenocarcinoma in terms of PFS, whose tumors has low or no ASNS expression (ASNS 0 or 1+)
9 secondary outcomes
Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)
Time frame: collected from time of informed consent until 4 weeks after last study treatment
Overall survival
Time frame: From last study treatment assessment visit until patient's death, loss to follow up, or study closure, assessed up to 36 months.
Progression free survival
Time frame: From date of randomization to first documented progression of disease, death for any cause or until start of new anti-cancer treatment, whcihever came first, assessed up to 24 months.
Objective response rate (ORR)
Time frame: From date of randomization to last tumor assessment data collected for each patient, assessed up to 24 months.
Disease control rate (DCR)
Time frame: From date of randomization to 16 and 24 weeks.
Duration of response (DoR)
Time frame: From date of first response of complete or partial response until tumor progression, assessed up to 24 months.
Evaluate the relationship of clinical outcomes with tumor markers
Time frame: From date of randomiztion to end of treatment visit, assessed up to 20 months.
Optical density reading
Time frame: From date of randomization to first documented progression of disease, death for any cause or until start of new anti-cancer treatment, whcihever came first, assessed up to 24 months.
Quality of Life status
Time frame: From date of randomiztion to end of treatment visit, assessed up to 20 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2018.
- Derived from this study: PubMed 32605910Bachet JB, Blons H, Hammel P, Hariry IE, Portales F, Mineur L, Metges JP, Mulot C, Bourreau C, Cain J, Cros J, Laurent-Puig P. Circulating Tumor DNA is Prognostic and Potentially Predictive of Eryaspase Efficacy in Second-line in Patients with Advanced Pancreatic Adenocarcinoma. Clin Cancer Res. 2020 Oct 1;26(19):5208-5216. doi: 10.1158/1078-0432.CCR-20-0950. Epub 2020 Jun 30.
- Derived from this study: PubMed 31760314Hammel P, Fabienne P, Mineur L, Metges JP, Andre T, De La Fouchardiere C, Louvet C, El Hajbi F, Faroux R, Guimbaud R, Tougeron D, Bouche O, Lecomte T, Rebischung C, Tournigand C, Cros J, Kay R, Hamm A, Gupta A, Bachet JB, El Hariry I. Erythrocyte-encapsulated asparaginase (eryaspase) combined with chemotherapy in second-line treatment of advanced pancreatic cancer: An open-label, randomized Phase IIb trial. Eur J Cancer. 2020 Jan;124:91-101. doi: 10.1016/j.ejca.2019.10.020. Epub 2019 Nov 21.
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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.
Pascal Hammel, Pr MD principal investigator
Hopital Beaujon
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ERY001, Gemcitabine and 5-fluoro-uracil/oxaliplatin/leucovorin (folfox) in people with Pancreatic Adenocarcinoma Metastatic, run by ERYtech Pharma at 16 sites in France.
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 9 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 27 Jul 2018. 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 France. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: From last study treatment assessment visit until patient's death, loss to follow up, or study closure, assessed up to 36 months.). The study lists 2 primary outcomes in all. 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 NCT02195180, which also lists 2 linked publications.
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 27 Jul 2018.