Trial · NCT06387342
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adverse Events | Every 2 weeks, assessed up to 1 year | Assessments of adverse events (AEs) will include characterization of type, incidence, severity (graded by CTCAE v5.0), seriousness, and relationship to treatment. |
| Primary | Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Change from baseline | Every 2 weeks, assessed up to 1 year | Eastern Cooperative Oncology Group (ECOG) Performance Status (PS), which is a scale of functioning, from 0 (normal activity) to 5 (death) |
| Secondary | Objective response rate | Every 8 weeks, assessed up to 1 year | clinical activity measure of objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), measured by computed tomography (CT) scan, positron emission tomography (PET) CT, and/or magnetic resonance imaging (MRI) |
| Secondary | Progression free survival | Every 8 weeks, assessed up to 1 year | clinical activity measure of progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), measured by computed tomography (CT) scan, positron emission tomography (PET) CT, and/or magnetic resonance imaging (MRI) |
| Secondary | Disease control rate | Every 8 weeks, assessed up to 1 year | clinical activity measure of disease control rate (DCR) |
| Secondary | Duration of response | Every 8 weeks, assessed up to 1 year | clinical activity measure of duration of response (DoR), defined as the time from first response to disease progression or death from any cause, whichever occurs first |
| Secondary | Overall survival | Every 8 weeks, assessed up to 1 year | clinical activity measure of overall survival (OS), including death from any cause |
| Other | Quality of Life evaluation with EORTC QLQ-C30 | Every 4 weeks, assessed up to 1 year | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30), in which summary scores range from 0 to 100, with higher scores indicating better health-related quality of life |
| Other | Quality of Life evaluation with EORTC QLQ-PAN26 | Every 4 weeks, assessed up to 1 year | European Organization for Research and Treatment of Cancer Quality of Life pancreatic adenocarcinoma-specific module, the EORTC QLQ-PAN26, in which summary scores range from 0 to 100, with higher scores indicating better health-related quality of life |
| Other | Pharmacokinetics of namodenoson: Cmax | Cycle 1, day 1 (each cycle is 28 days); Cycle 1, day 15, and Cycle 2, day 1 | Maximum plasma concentration of namodenoson |
| Other | Pharmacokinetics of namodenoson: Cmin | Cycle 1, day 1 (each cycle is 28 days); Cycle 1, day 15, and Cycle 2, day 1 | Minimum plasma concentration of namodenoson |
| Other | Pharmacokinetics of namodenoson: AUC(0-12) | Cycle 1, day 1 (each cycle is 28 days); Cycle 1, day 15, and Cycle 2, day 1 | Area under the curve of namodenoson plasma exposure from 0-12 hours post-dose |
| Other | Cancer antigen 19-9 (CA 19-9) | Every 4 weeks, assessed up to 1 year | Change from baseline in Cancer antigen 19-9 (CA 19-9) biomarker during treatment |
| Other | Carcinoembryonic Antigen (CEA) | Every 4 weeks, assessed up to 1 year | Change from baseline in Carcinoembryonic Antigen (CEA) biomarker during treatment |
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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