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Phase 2A Pilot C3 Trial of Recurrent/Refractory Metastatic Advanced Pancreatic Cancer

NCT06030622 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-04-19

No results posted yet for this 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.

Conditions

  • Pancreatic Cancer Metastatic

Interventions

DRUG

Gemcitabine and C3 (Metformin, Simvastatin, and Digoxin)

Combination treatment of Metformin, Simvastatin and Digoxin with Gemcitabine (Arm 1)

DRUG

C3 (Metformin, Simvastatin, and Digoxin) only

C3 only (Metformin, Simvastatin, and Digoxin) if patients decline Gemcitabine (Arm 2).

Sponsors & Collaborators

  • State University of New York - Downstate Medical Center

    lead OTHER

Principal Investigators

  • Mohan Preet, MD · SUNY Downstate Health Sciences University

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-17
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06030622 on ClinicalTrials.gov