Trial · NCT03504423
Study Evaluating Efficacy and Safety of FFX Versus Combination of CPI-613 With mFFX in Patients With Metastatic Adenocarcinoma of the Pancreas
NCT03504423, Phase 3, Completed, Cornerstone Pharmaceuticals; results first posted 2023-01-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study Evaluating Efficacy and Safety of FFX Versus Combination of CPI-613 With mFFX in Patients With Metastatic Adenocarcinoma of the Pancreas. Trials, record NCT03504423. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03504423
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Evaluating Efficacy and Safety of FFX Versus Combination of CPI-613 With mFFX in Patients With Metastatic Adenocarcinoma of the Pancreas
- NCT number
- NCT03504423
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 528 participants, actual
- Lead sponsor
- Cornerstone Pharmaceuticals
- Conditions
- Pancreatic Cancer Metastatic
- Interventions
- CPI 613, mFolfirinox, Folfirinox
- First posted
- 2018-04-20
- Last updated
- 2023-01-03
- Results first posted
- 2023-01-03
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | 38 months | Defined as the duration from the date of randomization to the date of death from any cause |
| Secondary | Progression Free Survival (PFS) | 38 months | Defined as the duration from the date of randomization to the date of progressive disease or death from any cause. Progressive Disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. |
| Secondary | Overall Response Rate (ORR) | 38 months | Defined as the rate of Complete Response (CR) plus Partial Response (PR): Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of diameters of target lesions; |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | 38 months | months | MEDIAN | |
| SECONDARY | Progression Free Survival (PFS) | 38 months | months | MEDIAN | |
| SECONDARY | Overall Response Rate (ORR) | 38 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | CPI-613, mFolfirinox | 11.10 | 95% Confidence Interval 10.22 to 12.94 | months | |
| Overall Survival (OS) | Folfirinox | 11.73 | 95% Confidence Interval 10.12 to 13.24 | months | |
| Progression Free Survival (PFS) | CPI-613, mFolfirinox | 7.82 | 95% Confidence Interval 6.97 to 10.91 | months | |
| Progression Free Survival (PFS) | Folfirinox | 7.98 | 95% Confidence Interval 7.23 to 11.14 | months | |
| Overall Response Rate (ORR) | CPI-613, mFolfirinox | 104 | Participants | ||
| Overall Response Rate (ORR) | Folfirinox | 90 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CPI-613, mFolfirinox | 266 | |
| Overall Study | STARTED | Folfirinox | 262 | |
| Overall Study | COMPLETED | CPI-613, mFolfirinox | 259 | |
| Overall Study | COMPLETED | Folfirinox | 235 | |
| Overall Study | NOT COMPLETED | CPI-613, mFolfirinox | 7 | |
| Overall Study | NOT COMPLETED | Folfirinox | 27 |
Source ClinicalTrials.gov
Adverse events1,862
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 | Anaemia | Blood and lymphatic system disorders | CPI-613, mFolfirinox | 120 | 259 | |
| other | Anaemia | Blood and lymphatic system disorders | Folfirinox | 94 | 235 | |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | CPI-613, mFolfirinox | 1 | 259 | |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Folfirinox | 0 | 235 | |
| other | Febrile bone marrow aplasia | Blood and lymphatic system disorders | CPI-613, mFolfirinox | 1 | 259 | |
| other | Febrile bone marrow aplasia | Blood and lymphatic system disorders | Folfirinox | 0 | 235 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | CPI-613, mFolfirinox | 7 | 259 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Folfirinox | 19 | 235 | |
| other | Immune thrombocytopenic purpura | Blood and lymphatic system disorders | CPI-613, mFolfirinox | 0 | 259 | |
| other | Immune thrombocytopenic purpura | Blood and lymphatic system disorders | Folfirinox | 1 | 235 |
1 to 10 of 1,862Source ClinicalTrials.gov
See all 1,862 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CPI-613, mFolfirinox | 140 | 259 |
| Total, all-cause mortality | Folfirinox | 133 | 235 |
| Total, other adverse events | CPI-613, mFolfirinox | 258 | 259 |
| Total, other adverse events | Folfirinox | 232 | 235 |
| Total, serious adverse events | CPI-613, mFolfirinox | 140 | 259 |
| Total, serious adverse events | Folfirinox | 133 | 235 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CPI-613, mFolfirinox vs Folfirinox: Overall Response Rate (ORR) | Trial comparisons |
| CPI-613, mFolfirinox vs Folfirinox: deaths from any cause | Trial comparisons |
| CPI-613, mFolfirinox vs Folfirinox: 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/NCT03504423
GET https://conductscience.org/api/trials/v1/NCT03504423/events?page=2