RECRUITING

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

Conditions

Pancreatic Cancer Metastatic C3 trial metformin simvastatin digoxin pancreatic cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase 2A Pilot Trial of Metformin, Digoxin, Simvastatin (C3) in Combination With Gemcitabine in Subjects With Recurrent / Refractory Metastatic Advanced Pancreatic Cancer

Quick Facts

Study Start:2024-04-17

Study Completion:2024-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06030622

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subject ≥18 years with histologically confirmed pancreatic cancer. 2. Refractory, intolerant to, or with disease progression after at least one standard of care regimen. 3. ECOG performance status (PS) 0-1. 4. Pretreatment biopsy and/or adequate archival tissue available for BIRC5 protein level evaluation. 5. Adequate organ and marrow function: absolute granulocyte count ≥1,000/mm3, platelets ≥100,000/mm3, total bilirubin ≤ institutional upper normal limit, AST/ALT ≤2x institutional upper limit of normal, and creatinine \<1.5 mg/dL or calculated creatinine clearance \> 60ml / min (Cockcroft-Gault Equation). 6. Subject has recovered to CTCAE Grade 1 (except for alopecia) or better from all adverse events associated with prior therapy or surgery. Pre-existing motor or sensory neurologic pathology or symptoms must be recovered to CTCAE Grade 2 or better. 7. If participant of childbearing potential, has a negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a negative serum test will be required for study entry. Serum pregnancy tests will be conducted at the time of screening, when other blood draws are obtained (See Appendix III: Time-Table of Procedures). 8. Ability to understand and the willingness to sign a written informed protocol specific consent. 9. Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. 10. No known active infections at the time of enrollment as determined by negative procalcitonin level.	1. Anti-cancer chemotherapy, biologic therapy or immunotherapy within 3 weeks or radiation therapy within 2 weeks of first investigational product administration. 2. Known history of other malignancy unless having undergone curative intent therapy without evidence of that disease for ≥ 3 years except cutaneous squamous cell and basal cell skin cancer, superficial bladder cancer, in situ cervical cancer or other in situ cancers are allowed if definitively resected. 3. Brain metastases unless treated with curative intent (gamma knife or surgical resection) and without evidence of progression for ≥ 2 months. 4. Known history of rhabdomyolysis. 5. History of or current evidence of any condition (including medical, psychiatric or substance abuse disorder), therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the Investigator. 6. Known chronic Hepatitis B or C infection. 7. Have current active infection requiring systemic antibiotic treatment. 8. History of severe allergic, anaphylactic, hypersensitivity reactions or previous intolerance to Metformin, Simvastatin, and/or Digoxin. 9. Patients with significant cardiac disease or condition listed below (unless clearance obtained by cardiology): 1. Wolff-Parkinson-White Syndrome. 2. Previous MI within last 6 months of C1D1. 3. Evidence of residual electrographic pattern consistent with heart block., for example atrio-ventricular (AV) heart block (currently ongoing). 4. History of ventricular fibrillation. 5. Sick Sinus Syndrome or Sinus bradycardia thought to be caused by sinus node disease, unless effectively treated. 6. Heart failure with preserved LVEF, including constructive pericarditis, and amyloid heart disease. 10. Acute cor pulmonale, restrictive cardiomyopathy, and Amyloid heart muscle disease. 11. Participants of childbearing potential who are found to be pregnant as evidenced by positive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) or nursing. 12. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or trial results. 13. Cognitively impaired and diminished capacity.

Inclusion Criteria

Exclusion Criteria

1. Subject ≥18 years with histologically confirmed pancreatic cancer.
2. Refractory, intolerant to, or with disease progression after at least one standard of care regimen.
3. ECOG performance status (PS) 0-1.
4. Pretreatment biopsy and/or adequate archival tissue available for BIRC5 protein level evaluation.
5. Adequate organ and marrow function: absolute granulocyte count ≥1,000/mm3, platelets ≥100,000/mm3, total bilirubin ≤ institutional upper normal limit, AST/ALT ≤2x institutional upper limit of normal, and creatinine \<1.5 mg/dL or calculated creatinine clearance \> 60ml / min (Cockcroft-Gault Equation).
6. Subject has recovered to CTCAE Grade 1 (except for alopecia) or better from all adverse events associated with prior therapy or surgery. Pre-existing motor or sensory neurologic pathology or symptoms must be recovered to CTCAE Grade 2 or better.
7. If participant of childbearing potential, has a negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a negative serum test will be required for study entry. Serum pregnancy tests will be conducted at the time of screening, when other blood draws are obtained (See Appendix III: Time-Table of Procedures).
8. Ability to understand and the willingness to sign a written informed protocol specific consent.
9. Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
10. No known active infections at the time of enrollment as determined by negative procalcitonin level.

1. Anti-cancer chemotherapy, biologic therapy or immunotherapy within 3 weeks or radiation therapy within 2 weeks of first investigational product administration.
2. Known history of other malignancy unless having undergone curative intent therapy without evidence of that disease for ≥ 3 years except cutaneous squamous cell and basal cell skin cancer, superficial bladder cancer, in situ cervical cancer or other in situ cancers are allowed if definitively resected.
3. Brain metastases unless treated with curative intent (gamma knife or surgical resection) and without evidence of progression for ≥ 2 months.
4. Known history of rhabdomyolysis.
5. History of or current evidence of any condition (including medical, psychiatric or substance abuse disorder), therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the Investigator.
6. Known chronic Hepatitis B or C infection.
7. Have current active infection requiring systemic antibiotic treatment.
8. History of severe allergic, anaphylactic, hypersensitivity reactions or previous intolerance to Metformin, Simvastatin, and/or Digoxin.
9. Patients with significant cardiac disease or condition listed below (unless clearance obtained by cardiology):
1. Wolff-Parkinson-White Syndrome.
2. Previous MI within last 6 months of C1D1.
3. Evidence of residual electrographic pattern consistent with heart block., for example atrio-ventricular (AV) heart block (currently ongoing).
4. History of ventricular fibrillation.
5. Sick Sinus Syndrome or Sinus bradycardia thought to be caused by sinus node disease, unless effectively treated.
6. Heart failure with preserved LVEF, including constructive pericarditis, and amyloid heart disease.
10. Acute cor pulmonale, restrictive cardiomyopathy, and Amyloid heart muscle disease.
11. Participants of childbearing potential who are found to be pregnant as evidenced by positive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) or nursing.
12. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or trial results.
13. Cognitively impaired and diminished capacity.

Contacts and Locations

Study Contact

Seema Chittalae, MD

CONTACT

(718) 221-6594

seema.chittalae@downstate.edu

Moro Salifu, MD

CONTACT

(718) 270-1584

moro.salifu@downstate.edu

Principal Investigator

Mohan Preet, MD

PRINCIPAL_INVESTIGATOR

SUNY Downstate Health Sciences University

Study Locations (Sites)

SUNY Downstate Health Sciences University

Brooklyn, New York, 11203

United States

Collaborators and Investigators

Sponsor: State University of New York - Downstate Medical Center

Mohan Preet, MD, PRINCIPAL_INVESTIGATOR, SUNY Downstate Health Sciences University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-17

Study Completion Date2024-12

Study Record Updates

Study Start Date2024-04-17

Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

C3 trial
metformin
simvastatin
digoxin
pancreatic cancer

Additional Relevant MeSH Terms

Pancreatic Cancer Metastatic