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NCT02550327 · ClinicalTrials.gov registry record · Early Phase 1
Gemcitabine, Nab-Paclitaxel, Cisplatin and Anakinra Treatment on Patients With Pancreatic Cancer
A Early Phase 1 study, sponsored by Baylor Research Institute.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
NCT02550327 is a Early Phase 1 study that has completed, run by Baylor Research Institute. The registered enrollment target is 20 participants.
The verdict
NCT02550327, a Early Phase 1 study, has completed, sponsored by Baylor Research Institute.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
The objective of this study is to improve survival by the addition of anakinra to the chemotherapy combination of nab-paclitaxel, gemcitabine, and cisplatin in patients with resectable or potentially resectable pancreatic adenocarcinoma (PDAC). The primary endpoint of the study is to determine whether the combination of abraxane, gemcitabine, cisplatin, and anakinra will improve disease-free survival (DFS) and to determine the number of patients who meet or surpass 11.5 months of DFS. The secondary objectives of this study are to evaluate the effect of anakinra when combined with the three-drug regimen of nab-paclitaxel, gemcitabine, and cisplatin on response rate and overall survival after diagnosis and adverse events of patients with resectable or potentially resectable PDAC. The investigators will use the benchmark of 24 months overall survival (OS) to determine how many patients meet or exceed this goal. The investigators will monitor, by survey, patients' health related quality of life while on treatment to determine if the addition of anakinra improves this measure.
Interventions
- DRUG Cisplatin
- DRUG Gemcitabine
- DRUG Nab-paclitaxel
- DRUG Anakinra
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2016-01 |
| Est. Completion | 2021-06-14 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02550327
The ClinicalTrials.gov registry entry for NCT02550327 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor Research Institute, which has 180 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Cisplatin is the first listed.
NCT02550327 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02550327 about?
NCT02550327 is a clinical study titled "Gemcitabine, Nab-Paclitaxel, Cisplatin and Anakinra Treatment on Patients With Pancreatic Cancer". The objective of this study is to improve survival by the addition of anakinra to the chemotherapy combination of nab-paclitaxel, gemcitabine, and cisplatin in patients with resectable or potentially resectable pancreatic adenocarcinoma (PDAC). The primary endpoint of the study is to determine wheth...
What is the current status of trial NCT02550327?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2016-01. Estimated completion is 2021-06-14.
What interventions are being tested in trial NCT02550327?
The interventions under investigation include: Cisplatin (DRUG), Gemcitabine (DRUG), Nab-paclitaxel (DRUG), Anakinra (DRUG).
Who is sponsoring clinical trial NCT02550327?
This trial is sponsored by Baylor Research Institute, which has 180 total clinical trials registered on ClinicalTrials.gov.
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