Trial · NCT07024615
A Study of ASP2138 Given Before Surgery, Then Chemotherapy After Surgery, in People With Pancreatic Ductal Cancer
NCT07024615, Phase 1, Recruiting, Astellas Pharma Global Development, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of ASP2138 Given Before Surgery, Then Chemotherapy After Surgery, in People With Pancreatic Ductal Cancer. Trials, record NCT07024615. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07024615
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of ASP2138 Given Before Surgery, Then Chemotherapy After Surgery, in People With Pancreatic Ductal Cancer
- NCT number
- NCT07024615
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 25 participants, estimated
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Interventions
- ASP2138, Oxaliplatin, Leucovorin, 5-FU, Irinotecan, Gemcitabine, Nab-paclitaxel, Capecitabine
- First posted
- 2025-06-17
- Last updated
- 2026-09-02
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with Adverse Events (AEs) | Up to 11.5 months | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. This includes events related to the comparator, if applicable, and events related to the (study) procedures. |
| Primary | Number of participants with Serious Adverse Events (SAEs) | Up to 11.5 months | A Serious Adverse Event is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other situations. |
| Primary | Number of participants with laboratory value abnormalities and/or AEs | Up to 11.5 months | Number of participants with potentially clinically significant laboratory values. |
| Primary | Number of participants with vital signs abnormalities and/or AEs | Up to 11.5 months | Number of participants with potentially clinically significant vital sign values. |
| Primary | Number of participants with 12-lead electrocardiogram (ECG) abnormalities and/or AEs | Up to 10.5 months | Number of participants with potentially clinically significant 12-Lead ECG values. |
| Primary | Number of participants with physical examinations (PEs) abnormalities and/or AEs | Up to 11.5 months | Number of participants with potentially clinically significant PEs values. |
| Primary | Number of participants at each grade of Eastern Cooperative Oncology Group (ECOG) performance status score | Up to 11.5 months | The ECOG scale will be used to assess performance status. Grades range from 0 (fully active) to 5 (dead). Negative change scores indicate an improvement. Positive scores indicate a decline in performance. |
| Primary | Number of participants with ASP2138-related surgery delays (≥ 7 days) | Up to 12 weeks after the end of neoadjuvant treatment | Surgery delay is defined as the interval (in days) between the pre-specified planned date of surgery and the actual date on which surgery is performed. Delays of ≥ 7 days that are assessed by the investigator as being related to ASP2138 (treatment-related) will be documented. |
| Secondary | Pharmacokinetics (PK) of ASP2138 in serum: concentration immediately prior to dosing at multiple dosing (Ctrough) | Up to 0.5 month | Ctrough will be recorded from the pharmacokinetic (PK) serum samples collected. |
| Secondary | Number of participants at each grade of Pathologic Response | Up to 10.5 months | The College of American Pathologists (CAP) grading will be used to assess pathological response. Grades range from 0: No viable cancer cells (complete response) to grade 3: Extensive residual cancer with no evident tumor regression (poor or no response) |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT07024615
GET https://conductscience.org/api/trials/v1/NCT07024615/registered