Trial · NCT07409272
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | Up to 3.5 years | OS is defined as the time from the date of randomization until the date of death from any cause. |
| Secondary | Progression-Free Survival (PFS) per RECIST v1.1. as assessed by the investigator. | Up to 3.5 years | PFS is defined as the time from the start of randomization until the date of documented radiological disease progression per RECIST v1.1 as assessed by the investigator or until death for any cause, whichever comes first. |
| Secondary | Time to Improvement in Pancreatic Pain (TIPP) measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-PAN26). | Up to 3.5 years | EORTC-QLQ-PAN26 is a 26-item questionnaire that evaluates pancreatic cancer-specific symptoms such as pain, dietary changes, jaundice, altered bowel habits, and emotional problems. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For symptom scales/items, higher scores indicate worse symptoms. |
| Secondary | Time to Worsening of General Health Status/Quality of Life (GHS/QoL) (TWGQ) measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). | Up to 3.5 years | The EORTC-QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For functional scales, higher scores indicate better functioning, while for symptom scales/items, higher scores indicate worse symptoms. |
| Secondary | Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, | Up to 3.5 years | ORR is defined as the proportion of participants whose best overall response is rated as complete response (CR) or partial response (PR) per RECIST v1.1. as assessed by the investigator. |
| Secondary | Number of Participants with Adverse Events (AEs) | Up to 3.5 years | An 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. |
| Secondary | Number of Participants with Serious Adverse Events (SAEs) | Up to 3.5 years | An SAE 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, and other medically important events. |
| Secondary | Number of Participants with laboratory value abnormalities and/or AEs | Up to 3.5 years | Number of participants with potentially clinically significant laboratory values. |
| Secondary | Number of Participants with electrocardiogram (ECG) abnormalities and/or AEs. | Up to 3.5 years | Number of participants with potentially clinically significant ECG values. |
| Secondary | Number of Participants with vital sign abnormalities and/or AEs. | Up to 3.5 years | Number of participants with potentially clinically significant vital sign values. |
| Secondary | Number of Participants with Eastern Cooperative Oncology Group (ECOG) performance status. | Up to 3.5 years | 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. |
| Secondary | Pharmacokinetics (PK) of setidegrasib End-of-Infusion (EOI) concentration | Up to 9 months | EOI Concentration will be recorded from plasma samples collected. |
| Secondary | PK of setidegrasib in plasma: concentration immediately prior to dosing at multiple dosing (Ctrough) | Up to 9 months | Ctrough will be recorded from plasma samples collected. |
| Secondary | Change from baseline in EORTC QLQ-PAN26 | Up to 3.5 years | EORTC-QLQ-PAN26 is a 26-item questionnaire that evaluates pancreatic cancer-specific symptoms such as pain, dietary changes, jaundice, altered bowel habits, and emotional problems. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For symptom scales/items, higher scores indicate worse symptoms. |
| Secondary | Change from baseline in EORTC QLQ-C30 | Up to 3.5 years | The EORTC-QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For functional scales, higher scores indicate better functioning, while for symptom scales/items, higher scores indicate worse symptoms. |
| Secondary | Change from baseline in EuroQol 5-dimensional 5-level version (EQ-5D-5L) | Up to 3.5 years | The EQ-5D-5L is a standardized instrument for use as a measure of health outcome consisting of 6 items that cover 5 main domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a general visual analog scale for health status. Each domain comprises 5 severity levels (no problems, slight problems, moderate problems, severe problems, extreme problems). The general visual analog scale records the respondent's self-rated health status on a vertical graduated (0 = the worst health a participant can imagine to 100 = the best health a participant can imagine) visual analogue scale. Responses to the 5 items will also be converted to a weighted health state index (utility score) based on values derived from general population samples. |
| Secondary | Change from baseline in Patient Global Impression of Change (PGIC). | Up to 3.5 years | The PGIC is a single-item questionnaire that asks participants to provide the overall self-assessment of change in their disease on a 7-point scale ranging from "very much worse" to "very much better" as compared to the participant starting the study treatment. Only PGIC questions assessing pain and overall status will be collected. |
| Secondary | Change from baseline in Patient Global Impression of Severity PGIS | Up to 3.5 years | The PGIS is a single-item questionnaire that asks participants to provide the overall self-assessment of their disease severity on a 4-point scale for the past week, with 1 as "None" and 4 as "Severe". Only PGIS questions assessing pain and overall status will be collected. |
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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