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NCT04524702 · ClinicalTrials.gov registry record · Phase 2
Paricalcitol and Hydroxychloroquine in Combination With Gemcitabine and Nab-Paclitaxel for Advanced Pancreatic Cancer
A Phase 2 study of Metastatic Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8, sponsored by Emory University.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 3
- Study locations
NCT04524702: Completed Phase 2 study of Metastatic Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8, sponsored by Emory University.
NCT04524702 is a Phase 2 study of Metastatic Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8 that has completed, run by Emory University. The registered enrollment target is 10 participants, below the 90-participant average among 37 other Metastatic Pancreatic Adenocarcinoma trials with a reported enrollment target (89% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04524702, a Phase 2 study of Metastatic Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase II trial investigates how well paricalcitol and hydroxychloroquine work when combined with gemcitabine and nab-paclitaxel in treating patients with pancreatic cancer that has spread to other places in the body (advanced or metastatic). Paricalcitol (a form of vitamin D) works by blocking a signal in the cancer cells that leads to growth and spreading of the tumor. Hydroxychloroquine (an autophagy inhibitor) enhances the activity of standard chemotherapy on cancer cells and prevent them to utilize energy to grow. Chemotherapy drugs, 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 paricalcitol and hydroxychloroquine together with standard chemotherapy (gemcitabine and nab-paclitaxel) may work better in treating patients with pancreatic cancer compared to either paricalcitol or hydroxychloroquine alone.
Primary Outcome
To evaluate the anti-tumor activity of the combination of paricalcitol plus hydroxychloroquine (PH) when added to gemcitabine and nab-paclitaxel treatment by assessing the Overall Response Rate (ORR) by RECIST 1.1. ORR is defined as the percentage of people in the trial who have partial response (PR) or complete response (CR). The Response rate will be estimated with Clopper-Pearson with a 90% exact confidence interval.
Conditions Studied
Interventions
- DRUG Gemcitabine
- DRUG Nab-paclitaxel
- DRUG Paricalcitol
- DRUG Hydroxychloroquine
Study Locations (3)
Georgia
- Emory University Hospital Midtown - Atlanta
- Emory University Hospital/Winship Cancer Institute - Atlanta
- Emory Saint Joseph's Hosptial - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2020-09-14 |
| Est. Completion | 2023-06-06 |
| Phase | Phase 2 |
What the finished NCT04524702 record still lists
NCT04524702 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 90-participant average among 37 other Metastatic Pancreatic Adenocarcinoma trials with a reported enrollment target (89% lower).
The record links to 3 conditions, with Metastatic Pancreatic Adenocarcinoma appearing as the primary indexed condition, and to 4 interventions - of which Gemcitabine is the first listed.
NCT04524702 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT04524702 about?
NCT04524702 is a clinical study titled "Paricalcitol and Hydroxychloroquine in Combination With Gemcitabine and Nab-Paclitaxel for Advanced Pancreatic Cancer". This phase II trial investigates how well paricalcitol and hydroxychloroquine work when combined with gemcitabine and nab-paclitaxel in treating patients with pancreatic cancer that has spread to other places in the body (advanced or metastatic). Paricalcitol (a form of vitamin D) works by blocking ...
What is the current status of trial NCT04524702?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2020-09-14. Estimated completion is 2023-06-06.
What conditions does trial NCT04524702 study?
This clinical trial studies the following conditions: Metastatic Pancreatic Adenocarcinoma, Stage IV Pancreatic Cancer AJCC v8, Advanced Pancreatic Adenocarcinoma.
What interventions are being tested in trial NCT04524702?
The interventions under investigation include: Gemcitabine (DRUG), Nab-paclitaxel (DRUG), Paricalcitol (DRUG), Hydroxychloroquine (DRUG).
Who is sponsoring clinical trial NCT04524702?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04524702 being conducted?
This trial has 3 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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