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

Part of paid clinical trials in Brooklyn, New York.

Sponsor
State University of New York - Downstate Medical Center
Study ID
NCT06030622
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Pancreatic Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine and C3 (Metformin, Simvastatin, and Digoxin) — DRUG
    Combination treatment of Metformin, Simvastatin and Digoxin with Gemcitabine (Arm 1)
  • C3 (Metformin, Simvastatin, and Digoxin) only — DRUG
    C3 only (Metformin, Simvastatin, and Digoxin) if patients decline Gemcitabine (Arm 2).

Study Details

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.

Key Dates

First listed
Sep 11, 2023
Start date
Apr 17, 2024
Status verified
Jul 2026
Primary completion
Dec 1, 2028
Completion
Dec 30, 2028

Study Design

Enrollment
25 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Gemcitabine and C3 (Combination Digoxin, Simvastatin, and Metformin)
    Study participants will be offered metformin (850 mg twice a day), digoxin (0.25 mg once a day), and simvastatin (20 mg once a day) combination (C3) and Gemcitabine.
  • Experimental: C3 (Combination Digoxin, Simvastatin, and Metformin) only
    Study participants will be offered C3 only metformin (850 mg twice a day), digoxin (0.25 mg once a day), and simvastatin (20 mg once a day) combination (C3) if they decline Gemcitabine.

Primary Outcome Measure

Primary Outcome: Safety and tolerability [ Time Frame: 28 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
SUNY Downstate Health Sciences UniversityBrooklynNew York11203
Mohan Preet, MD
[email protected]
(718) 270-1500
Arjun Kandel, MD
[email protected]

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By research site
SUNY Downstate Health Sciences University· Brooklyn, NY

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