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NCT06030622 · ClinicalTrials.gov registry record · Phase 1
Phase 2A Pilot C3 Trial of Recurrent/Refractory Metastatic Advanced Pancreatic Cancer
A Phase 1 study of Pancreatic Cancer Metastatic, sponsored by State University of New York - Downstate Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT06030622: Recruiting Phase 1 study of Pancreatic Cancer Metastatic, sponsored by State University of New York - Downstate Medical Center.
NCT06030622 is a Phase 1 study of Pancreatic Cancer Metastatic that is actively recruiting participants, run by State University of New York - Downstate Medical Center. The registered enrollment target is 25 participants, below the 129-participant average among 9 other Pancreatic Cancer Metastatic trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06030622, a Phase 1 study of Pancreatic Cancer Metastatic, is actively recruiting participants, sponsored by State University of New York - Downstate Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
The goals of this trial are: 1) To evaluate the safety and tolerability of C3 administration with Gemcitabine; and 2) To assess the disease response following C3 administration with Gemcitabine. The main question it aims to answer are: 1) Is C3 in combination with Gemcitabine safe, tolerable, and effective for reducing improving advanced stage pancreatic cancer? and 2) Can C3 in combination with Gemcitabine prolong the lives of patients with advanced stage pancreatic cancer. Participants will receive a combination of metformin (850 mg twice a day), digoxin (0.25 mg once a day), and simvastatin (20 mg once a day), also known as C3, and Gemcitabine (as per standard of care) for 2 years. If patients decline Gemcitabine, they will be offered the C3 medications only.
Primary Outcome
Number of participants with treatment-related Adverse Events as assessed by CTCAE v4.0
Conditions Studied
Interventions
- DRUG Gemcitabine and C3 (Metformin, Simvastatin, and Digoxin)
- DRUG C3 (Metformin, Simvastatin, and Digoxin) only
Study Locations (1)
New York
- SUNY Downstate Health Sciences University - Brooklyn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2024-04-17 |
| Est. Completion | 2024-12 |
| Phase | Phase 1 |
What NCT06030622 shows while recruiting
NCT06030622 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 129-participant average among 9 other Pancreatic Cancer Metastatic trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Pancreatic Cancer Metastatic appearing as the primary indexed condition, and to 2 interventions - of which Gemcitabine and C3 (Metformin, Simvastatin, and Digoxin) is the first listed.
NCT06030622 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06030622 about?
NCT06030622 is a clinical study titled "Phase 2A Pilot C3 Trial of Recurrent/Refractory Metastatic Advanced Pancreatic Cancer". The goals of this trial are: 1) To evaluate the safety and tolerability of C3 administration with Gemcitabine; and 2) To assess the disease response following C3 administration with Gemcitabine. The main question it aims to answer are: 1) Is C3 in combination with Gemcitabine safe, tolerable, and ef...
What is the current status of trial NCT06030622?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2024-04-17. Estimated completion is 2024-12.
What conditions does trial NCT06030622 study?
This clinical trial studies the following conditions: Pancreatic Cancer Metastatic.
What interventions are being tested in trial NCT06030622?
The interventions under investigation include: Gemcitabine and C3 (Metformin, Simvastatin, and Digoxin) (DRUG), C3 (Metformin, Simvastatin, and Digoxin) only (DRUG).
Who is sponsoring clinical trial NCT06030622?
This trial is sponsored by State University of New York - Downstate Medical Center, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06030622 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06030622's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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