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NCT04115163 · ClinicalTrials.gov registry record · Phase 2
Biologically Optimized Infusion Schedule of Gemcitabine and Nab-Paclitaxel for the Treatment of Metastatic Pancreatic Cancer
A Phase 2 study of Metastatic Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8, sponsored by Anne Noonan.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 67
- Enrollment target
- 1
- Study location
NCT04115163: Recruiting Phase 2 study of Metastatic Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8, sponsored by Anne Noonan.
NCT04115163 is a Phase 2 study of Metastatic Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8 that is actively recruiting participants, run by Anne Noonan. The registered enrollment target is 67 participants, below the 88-participant average among 37 other Metastatic Pancreatic Adenocarcinoma trials with a reported enrollment target (24% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04115163, a Phase 2 study of Metastatic Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8, is actively recruiting participants, sponsored by Anne Noonan.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 67 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well a biologically optimized infusion schedule of gemcitabine and nab-paclitaxel works in treating patients with pancreatic cancer that has spread to other places in the body (metastatic). 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. Altering the timing of the nab-paclitaxel infusion may improve response in patients with pancreatic cancer.
Primary Outcome
ORR will be assessed by Response Evaluation Criteria in Solid Tumors 1.1 in patients with advanced pancreatic adenocarcinoma to receive optimized infusion schedule of gemcitabine plus nab-paclitaxel. The ORR will be calculated as the proportion of patients who achieve a response to therapy divided by the total number of evaluable patients. All evaluable patients will be included in calculating the ORR for the study along with corresponding 95% binomial confidence intervals (CIs) (assuming that t
Conditions Studied
Interventions
- DRUG Gemcitabine
- DRUG Nab-paclitaxel
Study Locations (1)
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2020-06-24 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What NCT04115163 shows while recruiting
NCT04115163 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 88-participant average among 37 other Metastatic Pancreatic Adenocarcinoma trials with a reported enrollment target (24% lower).
The record links to 2 conditions, with Metastatic Pancreatic Adenocarcinoma appearing as the primary indexed condition, and to 2 interventions - of which Gemcitabine is the first listed.
NCT04115163 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT04115163 about?
NCT04115163 is a clinical study titled "Biologically Optimized Infusion Schedule of Gemcitabine and Nab-Paclitaxel for the Treatment of Metastatic Pancreatic Cancer". This phase II trial studies how well a biologically optimized infusion schedule of gemcitabine and nab-paclitaxel works in treating patients with pancreatic cancer that has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as gemcitabine and nab-paclitaxel, work in di...
What is the current status of trial NCT04115163?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 67 participants. The study started on 2020-06-24. Estimated completion is 2026-12-31.
What conditions does trial NCT04115163 study?
This clinical trial studies the following conditions: Metastatic Pancreatic Adenocarcinoma, Stage IV Pancreatic Cancer AJCC v8.
What interventions are being tested in trial NCT04115163?
The interventions under investigation include: Gemcitabine (DRUG), Nab-paclitaxel (DRUG).
Who is sponsoring clinical trial NCT04115163?
This trial is sponsored by Anne Noonan, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04115163 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04115163's enrollment target sits among peer trials
67 13th of 37 higher than 25 of 37 other Metastatic Pancreatic Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Pancreatic Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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