Trial · NCT07024615
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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) |
| Secondary | Disease-free survival (DFS) | Up to 11.5 months | Disease-free survival (DFS) is defined as the time from date of surgical resection of pancreas tumor until the date of radiological disease recurrence or death due to any cause |
| Secondary | Number of participants with microscopically margin-negative (R0) resection | Up to 10.5 months |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT07024615/registered