Trial · NCT04158635
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 | Incidence of adverse events | Up to 30 days after last dose of protocol therapy | Will be recorded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0. |
| Primary | Dose limiting toxicities (DLTs) | Up to 21 days (Cycle 1) | Toxicities will be graded according to NCI CTCAE v 4.0. DLT's apply only to bosentan-only single stage AND cycle 1 and should be attributable to the treatment. |
| Primary | Compliance | During the first week | Number of bosentan tablets and bottles returned will be reconciled with the patient diary. |
| Secondary | Progression-free survival (PFS) | Time to disease progression/ relapse or death as a result of any cause, assessed up to 2 years | Will be evaluated using the Kaplan-Meier methods, both as a single group and by disease classification (metastatic versus \[vs.\] advanced unresectable). Response will also be examined by disease classification as part of a secondary analysis. |
| Secondary | Overall survival (OS) | Time to death as a result of any cause, assessed up to 2 years | Will be evaluated using the Kaplan-Meier methods, both as a single group and by disease classification (metastatic vs. advanced unresectable). Response will also be examined by disease classification as part of a secondary analysis. |
| Secondary | Time to treatment failure (TTF) | Time to treatment termination for any reason (progression, toxicity, death, patient preference), assessed up to 2 years | Will be evaluated using the Kaplan-Meier methods, both as a single group and by disease classification (metastatic vs. advanced unresectable). Response will also be examined by disease classification as part of a secondary analysis. |
| Other | Temporal impact of bosentan therapy on tumor vs. normal pancreatic tissue perfusion profile (tumor stroma and blood flow) | Up to 2 years | |
| Other | Levels of nab-paclitaxel, bosentan and active plasma metabolite Ro 48-5033 | Up to 2 years | Will be quantitated in the peripheral blood. |
| Other | Analysis of loci that encode organic anion transporting polypeptides (OATP) in participants who experience severe hepatotoxicity, increased during protocol therapy | Up to 2 years | |
| Other | Quantification of the number of circulating tumor cells and temporal proteomic/micro ribonucleic acid (miRNA) profile will assess response to therapy | Up to 2 years | |
| Other | Histopathology/ structural assessment and quantification of the miRNA profile | Up to 2 years | Will allow the identification of prognostic biomarkers. |
| Other | Quality of life assessment | Up to 2 years | Assesses using Functional Assessment of Cancer Therapy: General (FACT-G) questionnaire. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04158635/registered