Trial · NCT03665441
Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment in PAC
NCT03665441, Phase 3, Completed, ERYtech Pharma; results first posted 2022-09-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment in PAC. Trials, record NCT03665441. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03665441
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment in PAC
- NCT number
- NCT03665441
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 512 participants, actual
- Lead sponsor
- ERYtech Pharma
- Conditions
- Pancreatic Adenocarcinoma
- Interventions
- eryaspase, Gemcitabine plus Abraxane, Irinotecan plus 5-FU plus leucovorin
- First posted
- 2018-09-11
- Last updated
- 2022-10-18
- Results first posted
- 2022-09-28
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | ~12 months | To determine whether the addition of eryaspase to chemotherapy improves OS when compared to chemotherapy alone |
| Secondary | Progression Free Survival (PFS) | ~24 weeks | 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. |
| Secondary | Objective Response Rate (ORR) | ~24 weeks | 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. |
| Secondary | Duration of Response (DoR) | ~24 weeks | To compare the DoR between the 2 treatment arms |
| Secondary | Disease Control Rate (DCR) | ~24 weeks | To compare the between the 2 treatment arms |
| Secondary | Incidence of Treatment Emergent Adverse Events as Assessed by CTCAE v5.0 | ~9 months | 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 |
| Secondary | Time to Quality of Life Questionnaire EORTC QLQ-C30 First Worsening in Global Health Status Analysis | ~1 year | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | ~12 months | months | MEDIAN | |
| SECONDARY | Progression Free Survival (PFS) | ~24 weeks | months | MEDIAN | |
| SECONDARY | Objective Response Rate (ORR) | ~24 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Duration of Response (DoR) | ~24 weeks | months | MEDIAN | |
| SECONDARY | Disease Control Rate (DCR) | ~24 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Incidence of Treatment Emergent Adverse Events as Assessed by CTCAE v5.0 | ~9 months | Analysis set includes only patients who were treated on study (Safety Population). 7 patients in the eryaspase plus chemotherapy arm and 11 patients in the chemotherapy alone arm discontinued study prior to initiation of first dose. | participants | NUMBER |
| SECONDARY | Time to Quality of Life Questionnaire EORTC QLQ-C30 First Worsening in Global Health Status Analysis | ~1 year | The number of participants in this section consist of all patients who receive at least one dose of the study treatment and provide answers to at least some items of the EORTC QLQ-C30 at Cycle 1 Day 1 (i.e, baseline) and a time point after the date of first dose of study treatment. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Eryaspase Plus Chemotherapy | 7.5 | 95% Confidence Interval 6.5 to 8.3 | months | |
| Overall Survival (OS) | Chemotherapy Alone | 6.7 | 95% Confidence Interval 5.4 to 7.5 | months | |
| Progression Free Survival (PFS) | Eryaspase Plus Chemotherapy | 3.7 | 95% Confidence Interval 3.4 to 4.1 | months | |
| Progression Free Survival (PFS) | Chemotherapy Alone | 3.4 | 95% Confidence Interval 2 to 3.7 | months | |
| Objective Response Rate (ORR) | Eryaspase Plus Chemotherapy | 41 | Participants | ||
| Objective Response Rate (ORR) | Chemotherapy Alone | 32 | Participants | ||
| Duration of Response (DoR) | Eryaspase Plus Chemotherapy | 5.7 | 95% Confidence Interval 3.9 to 7.4 | months | |
| Duration of Response (DoR) | Chemotherapy Alone | 6.8 | 95% Confidence Interval 2.8 to 7.4 | months | |
| Disease Control Rate (DCR) | Eryaspase Plus Chemotherapy | 147 | Participants | ||
| Disease Control Rate (DCR) | Chemotherapy Alone | 126 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Eryaspase Plus Chemotherapy | 255 | |
| Overall Study | STARTED | Chemotherapy Alone | 257 | |
| Overall Study | COMPLETED | Eryaspase Plus Chemotherapy | 216 | |
| Overall Study | COMPLETED | Chemotherapy Alone | 240 | |
| Overall Study | NOT COMPLETED | Eryaspase Plus Chemotherapy | 39 | |
| Overall Study | NOT COMPLETED | Chemotherapy Alone | 17 |
Source ClinicalTrials.gov
Adverse events350
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Asthenia | General disorders | Eryaspase Plus Chemotherapy | 186 | 248 | |
| other | Asthenia | General disorders | Chemotherapy Alone | 73 | 246 | |
| other | Diarrhoea | Gastrointestinal disorders | Eryaspase Plus Chemotherapy | 132 | 248 | |
| other | Diarrhoea | Gastrointestinal disorders | Chemotherapy Alone | 107 | 246 | |
| other | Anaemia | Blood and lymphatic system disorders | Eryaspase Plus Chemotherapy | 128 | 248 | |
| other | Anaemia | Blood and lymphatic system disorders | Chemotherapy Alone | 97 | 246 | |
| other | Nausea | Gastrointestinal disorders | Eryaspase Plus Chemotherapy | 132 | 248 | |
| other | Nausea | Gastrointestinal disorders | Chemotherapy Alone | 89 | 246 | |
| other | Neutropenia | Blood and lymphatic system disorders | Eryaspase Plus Chemotherapy | 108 | 248 | |
| other | Neutropenia | Blood and lymphatic system disorders | Chemotherapy Alone | 93 | 246 |
1 to 10 of 350Source ClinicalTrials.gov
See all 350 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Eryaspase Plus Chemotherapy | 209 | 248 |
| Total, all-cause mortality | Chemotherapy Alone | 211 | 246 |
| Total, other adverse events | Eryaspase Plus Chemotherapy | 248 | 248 |
| Total, other adverse events | Chemotherapy Alone | 244 | 246 |
| Total, serious adverse events | Eryaspase Plus Chemotherapy | 122 | 248 |
| Total, serious adverse events | Chemotherapy Alone | 105 | 246 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41187298 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Eryaspase Plus Chemotherapy vs Chemotherapy Alone: Disease Control Rate (DCR) | Trial comparisons |
| Eryaspase Plus Chemotherapy vs Chemotherapy Alone: deaths from any cause | Trial comparisons |
| Eryaspase Plus Chemotherapy vs Chemotherapy Alone: Objective Response Rate (ORR) | Trial comparisons |
| Eryaspase Plus Chemotherapy vs Chemotherapy Alone: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03665441
GET https://conductscience.org/api/trials/v1/NCT03665441/results?page=2