Trial · NCT02697058
Phase II of BAX2398/5-FU/Calcium Levofolinate in Pancreatic Cancer
NCT02697058, Phase 2, Completed, Institut de Recherches Internationales Servier
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase II of BAX2398/5-FU/Calcium Levofolinate in Pancreatic Cancer. Trials, record NCT02697058. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02697058
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II of BAX2398/5-FU/Calcium Levofolinate in Pancreatic Cancer
- NCT number
- NCT02697058
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 84 participants, actual
- Lead sponsor
- Institut de Recherches Internationales Servier
- Conditions
- Metastatic Pancreatic Cancer
- Interventions
- BAX2398 + 5-FU/calcium levofolinate, 5-FU/calcium levofolinate
- First posted
- 2016-03-03
- Last updated
- 2024-07-25
Source ClinicalTrials.gov
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) in Part 2 of Study | Part 2 Baseline to the end of the study (up to 22 months) | Progression Free Survival (PFS) was defined as the time from randomization to the first documented disease progression based on the independent central review board's assessment using RECIST 1.1 or death due to any cause, whichever occurred first. |
| Secondary | Progression Free Survival (PFS) in Part 1 of Study | Part 1 Baseline to the end of the study (up to 22 months) | Progression Free Survival (PFS) was defined as the time from randomization to the first documented disease progression based on the independent central review board's assessment using RECIST 1.1 or death due to any cause, whichever occurred first. |
| Secondary | Overall Survival (OS) | Baseline to the end of the study (up to 22 months) | OS was defined as the time from the date of informed consent (Part 1) or date of randomization (Part 2) to death due to any cause or the date of last known alive. |
| Secondary | Time to Treatment Failure (TTF) | Baseline to the end of the study (up to 22 months) | TTF was defined as the time from randomization to disease progression according to RECIST 1.1, death due to any cause, discontinuation of treatment due to toxicity, or for symptomatic deterioration, or start of another anticancer therapy |
| Secondary | Objective Response Rate (ORR) | Baseline to the end of the study (up to 22 months) | ORR was defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) |
| Secondary | Disease Control Rate (DCR) | Baseline to the end of the study (up to 22 months) | DCR was defined as the proportion of participants with a best overall response of complete response (CR); partial response (PR); or stable disease (SD) lasting \>=24 weeks |
| Secondary | Tumor Marker Response | Baseline, every 6 weeks and 37 days post last visit (up to 22 months) | Tumor marker response was defined as decrease of 50% of cancer antigen (CA)-19-9 in relation to the baseline level at least once during the treatment period. Tumor marker response evaluable population consist of participants who have elevated CA-19-9 level (greater than \[\<\] 30 international unit \[IU\] / millilitre \[ml\]) at baseline and at least one post baseline CA-19-9 assessment. |
| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores | Baseline, Day 1 of Cycle 4, 7, 10, 13, and 16; and 37 days post last visit (up to 22 months) | The EORTC-QLQC30 is a reliable and valid measure of the quality of life of cancer participants in multicultural clinical research settings. It incorporates nine multi-item scales: five functional scales (physical \[PFS\], role \[RFS\], cognitive \[CFS\], emotional \[EFS\], and social \[SFS\]); three symptom scales (fatigue \[FSS\], pain \[PSS\], and nausea and vomiting \[NVSS\]); and a global health status (GHS) and quality-of-life scale. Several single-item symptom measures are also included. All scales and single-item measures range=0 to 100. High score for a functional scale=high/healthy level of functioning. High score for global health status/QoL=high QoL. High score for symptom scale/single item=high level of symptomatology/problems. |
| Secondary | Change From Baseline in Pain | Baseline, Days 1 and 8 of Cycles 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 16, 17, Day 1 of Cycles 3, 6, 9, 12, 15, 18 and 37 days post last visit (up to 22 months) | Participants assessed pain on the VAS. VAS range: 0 (no pain) to 100 worst pain. |
| Secondary | Change from Baseline in Analgesic use | Baseline, Days 1 and 8 of Cycles 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 16, 17, Day 1 of Cycles 3, 6, 9, 12, 15, 18 and 37 days post last visit (up to 22 months) | Participants recorded their analgesic usage in diaries. |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33099898 | BACKGROUND |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02697058
GET https://conductscience.org/api/trials/v1/NCT02697058/registered?page=2