Is NCT06030622 recruiting in Brooklyn, NY?

Yes, NCT06030622 is currently recruiting participants at its Brooklyn, NY location. This pancreatic cancer metastatic clinical trial is actively enrolling qualified participants.

How do I join the pancreatic cancer metastatic clinical trial in Brooklyn?

To join this clinical trial in Brooklyn, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Brooklyn clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Pancreatic Cancer Metastatic Clinical Trial in Brooklyn, NY

About This Pancreatic Cancer Metastatic Study in Brooklyn

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.

Sponsor: State University of New York - Downstate Medical Center

Who Can Participate

Inclusion Criteria

Subject ≥18 years with histologically confirmed pancreatic cancer.

Refractory, intolerant to, or with disease progression after at least one standard of care regimen.

ECOG performance status (PS) 0-1.

Pretreatment biopsy and/or adequate archival tissue available for BIRC5 protein level evaluation.

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).

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.

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).

Ability to understand and the willingness to sign a written informed protocol specific consent.

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.

No known active infections at the time of enrollment as determined by negative procalcitonin level.

Exclusion Criteria

Anti-cancer chemotherapy, biologic therapy or immunotherapy within 3 weeks or radiation therapy within 2 weeks of first investigational product administration.

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.

Brain metastases unless treated with curative intent (gamma knife or surgical resection) and without evidence of progression for ≥ 2 months.

Known history of rhabdomyolysis.

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.

Known chronic Hepatitis B or C infection.

Have current active infection requiring systemic antibiotic treatment.

History of severe allergic, anaphylactic, hypersensitivity reactions or previous intolerance to Metformin, Simvastatin, and/or Digoxin.

Patients with significant cardiac disease or condition listed below (unless clearance obtained by cardiology):

Wolff-Parkinson-White Syndrome.

Previous MI within last 6 months of C1D1.

Evidence of residual electrographic pattern consistent with heart block., for example atrio-ventricular (AV) heart block (currently ongoing).

History of ventricular fibrillation.

Sick Sinus Syndrome or Sinus bradycardia thought to be caused by sinus node disease, unless effectively treated.

Heart failure with preserved LVEF, including constructive pericarditis, and amyloid heart disease.

Acute cor pulmonale, restrictive cardiomyopathy, and Amyloid heart muscle disease.

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.

Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or trial results.

Cognitively impaired and diminished capacity.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Brooklyn?

Yes, this clinical trial (NCT06030622) has an active research site in Brooklyn, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Pancreatic Cancer Metastatic Treatment Options in Brooklyn, NY

If you're searching for pancreatic cancer metastatic treatment options in Brooklyn, NY, this clinical trial (NCT06030622) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Brooklyn research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced pancreatic cancer metastatic specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all pancreatic cancer metastatic clinical trials near you to find additional studies recruiting in your area.

Pancreatic Cancer Metastatic Clinical Trial in Brooklyn, NY

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