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NCT04158635 · ClinicalTrials.gov registry record · Phase 1
Gemcitabine, Nab-Paclitaxel, and Bosentan for the Treatment of Unresectable Pancreatic Cancer
A Phase 1 study of Stage IV Pancreatic Cancer AJCC v8 and Stage III Pancreatic Cancer AJCC v8, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT04158635 is a Phase 1 study of Stage IV Pancreatic Cancer AJCC v8 and Stage III Pancreatic Cancer AJCC v8 that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 21 participants, below the 88-participant average among 31 other Stage IV Pancreatic Cancer AJCC v8 trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04158635, a Phase 1 study of Stage IV Pancreatic Cancer AJCC v8 and Stage III Pancreatic Cancer AJCC v8, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the side effects and best dose of bosentan and how well it works when given together with gemcitabine and nab-paclitaxel for the treatment of pancreatic cancer that cannot be removed by surgery (unresectable). Bosentan may block the hormone endothelin and prevent the growth and spread of pancreatic cancer. Drugs used in chemotherapy, such as gemcitabine and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving bosentan with chemotherapy (gemcitabine and nab-paclitaxel) may work better in treating patients with pancreatic cancer compared to chemotherapy alone.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- DRUG Gemcitabine
- DRUG Nab-paclitaxel
- DRUG Bosentan
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2021-09-01 |
| Est. Completion | 2026-01-27 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04158635
The ClinicalTrials.gov registry entry for NCT04158635 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 88-participant average among 31 other Stage IV Pancreatic Cancer AJCC v8 trials with a reported enrollment target (76% lower). The listed sponsor is City of Hope Medical Center, which has 582 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Stage IV Pancreatic Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT04158635 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04158635 about?
NCT04158635 is a clinical study titled "Gemcitabine, Nab-Paclitaxel, and Bosentan for the Treatment of Unresectable Pancreatic Cancer". This phase I trial studies the side effects and best dose of bosentan and how well it works when given together with gemcitabine and nab-paclitaxel for the treatment of pancreatic cancer that cannot be removed by surgery (unresectable). Bosentan may block the hormone endothelin and prevent the growt...
What is the current status of trial NCT04158635?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2021-09-01. Estimated completion is 2026-01-27.
What conditions does trial NCT04158635 study?
This clinical trial studies the following conditions: Stage IV Pancreatic Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8, Unresectable Pancreatic Carcinoma.
What interventions are being tested in trial NCT04158635?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Gemcitabine (DRUG), Nab-paclitaxel (DRUG), Bosentan (DRUG).
Who is sponsoring clinical trial NCT04158635?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04158635 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.