Pancreatic Cancer MetastaticPhase 1/2C3NCT06030622
Phase 2A Pilot C3 Trial of Recurrent/Refractory Metastatic Advanced Pancreatic Cancer
A Phase 1/2 study testing Gemcitabine and C3 (Metformin, Simvastatin, and Digoxin) and C3 (Metformin, Simvastatin, and Digoxin) only in people with Pancreatic Cancer Metastatic, run by State University of New York - Downstate Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer Metastatic
- What is being tested?
- Gemcitabine and C3 (Metformin, Simvastatin, and Digoxin) and C3 (Metformin, Simvastatin, and Digoxin) only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2024to 30 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
SUNY Downstate Health Sciences University
Brooklyn, New York, 11203
Mohan Preet, MD, (718) 270-1500, mohan.preet@downstate.edu
Arjun Kandel, MD, arjun.kandel@downstate.edu
About this study
Official title: Phase 2A Pilot Trial of Metformin, Digoxin, Simvastatin (C3) in Combination With Gemcitabine in Subjects With 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 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.
Read the detailed description
Background. Pancreatic Ductal Adenocarcinoma (PDAC) is one of the deadliest cancers and ranks fourth in cancer-related deaths in the United States. It is among the 10 most commonly diagnosed cancers (9th in women and 10th in men), with approximately 56,770 new cases and 45,750 deaths in 2019. Current therapy for advanced disease includes the use of medications such as Gemcitabine, Erlotinib, Capecitabine, or combination treatments such as 5-fluorouracil, irinotecan, and oxaliplatin; or Gemcitabine and nab-paclitaxel. These standard of care medications have a survival advantage of less than six months in patients with advanced metastatic disease. Recent studies have shown that the use of metformin and simvastatin in 15,099 patients with pancreatic cancer significantly improved their survival.
Study Design/Methods. Based on those prior studies, the investigators will conduct an open-label, single-center, phase 2, feasibility trial of a combined metformin, digoxin, and simvastatin (C3) in 25 subjects with recurrent/refractory metastatic pancreatic cancer in order to evaluate their safety and tolerability. Patients who were previously treated for advanced pancreatic disease with no significant improvements in their disease, will be enrolled in this trial. C3 will be given as oral pills as described in recommended package insert safe levels in addition to their standard of care medication, Gemcitabine.
Study Interventions/Treatment Plan. The treatment plan is as follows: The first 3 patients enrolled in the study, will receive metformin (850 mg twice a day), digoxin (0.25 mg once a day), and simvastatin (20 mg once a day) for 28 days. If no toxic effects, the remaining 22 patients will be enrolled. Patients will be provided C3 medications every 28 days and will continue on the C3 medication for at least 2 years, or until death or recurrence/advancement of the disease. If more than one patient develops a toxic event, the dose will be reduced to metformin 850 mg/day, simvastatin 5 mg/day, and digoxin 0.0625 mg/day. If no further toxicities, then the remaining patients will receive the lower dose. If however, more than two patients develop a toxic event, then study discontinuation will be considered. If patients decline first line treatment (Gemcitabine), they will be offered a choice of C3 medications only.
Safety and Disease Response Assessments. During the conduct of the study, safety assessments will be conducted including physical examination, vital signs monitoring, performance status evaluation, blood CBC/serum chemistry, digoxin levels, toxicity assessment, and radiological tumor assessment. Disease response will be assessed using radiologic tumor assessments, and levels of biomarkers.
Objectives and Endpoints. The Primary Objectives are: 1) To evaluate the safety and tolerability of C3 administration with Gemcitabine. Endpoint and Outcome Measures: Adverse events and abnormalities in laboratory test values, markedly abnormal vital sign measurements; and 2) To assess disease response following C3 administration with Gemcitabine. Endpoint and Outcome Measures: Radiologic tumor assessment at baseline and quarterly thereafter. The Secondary Objectives are: 1) To assess levels of tumor biomarkers. Endpoint and Outcome Measures: Biomarker levels will be determined at baseline and at 2 months after C3 treatment; and 2) To assess molecular changes in biomarkers induced by C3 administration. Endpoint and Outcome Measures: Molecular expressions of tumor biomarkers such as BIRC5, CA19-9, and CEA at baseline, and 2 months after C3 treatment.
Given the safety profile of C3 in thousands of patients, the investigators anticipate that it will significantly improve the disease outcomes and prolong the lives of patients with metastatic advanced pancreatic cancer.
- Conditions
- Pancreatic Cancer Metastatic
- Being tested
- Gemcitabine and C3 (Metformin, Simvastatin, and Digoxin), C3 (Metformin, Simvastatin, and Digoxin) only
- Keywords
- C3 trial, metformin, simvastatin, digoxin, pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine and C3 (Metformin, Simvastatin, and Digoxin)Drug
Also called Glucophage, Zocor, Digitalis, Gemzar
Combination treatment of Metformin, Simvastatin and Digoxin with Gemcitabine (Arm 1)
C3 (Metformin, Simvastatin, and Digoxin) onlyDrug
Also called Glucophage, Zocor, Digitalis
C3 only (Metformin, Simvastatin, and Digoxin) if patients decline Gemcitabine (Arm 2).
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine and C3 (Combination Digoxin, Simvastatin, and Metformin) | Experimental | 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. Receives: Drug: Gemcitabine and C3 (Metformin, Simvastatin, and Digoxin) |
| C3 (Combination Digoxin, Simvastatin, and Metformin) only | Experimental | 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. Receives: Drug: C3 (Metformin, Simvastatin, and Digoxin) only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome: Safety and tolerability
Number of participants with treatment-related Adverse Events as assessed by CTCAE v4.0
Measured: 28 days
Secondary outcomes (1)
Secondary Outcome: Biomarkers
Tumor biomarkers as assessed by levels of BIRC5, CA19-9, CEA.
Measured: Before and 2 months after C3 treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start17 Apr 2024
- Primary completion1 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- The treatment plan is as follows: The first 3 patients enrolled in the study, will receive metformin (850 mg twice a day), digoxin (0.25 mg once a day), and simvastatin (20 mg once a day) for 28 days. If no toxic effects, the remaining 22 patients will be enrolled. Patients will be provided C3 medications every 28 days and will continue on the C3 medication for at least 2 years, or until death or recurrence/advancement of the disease. If more than one patient develops a toxic event, the dose will be reduced to metformin 850 mg/day, simvastatin 5 mg/day, and digoxin 0.0625 mg/day. If no further toxicities, then the remaining patients will receive the lower dose. If however, more than two patients develop a toxic event, then study discontinuation will be considered. If patients decline first line therapy (Gemcitabine), they will be offered the choice of C3 medications only.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York - Downstate Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Preet, State University of New York - Downstate Medical Center
- Investigators
- Mohan Preet, MD, Principal investigator, SUNY Downstate Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030622
- Sponsor's protocol ID
- 1727019-4
- Acronym
- C3
- Status last verified
- Jul 2026
- First submitted
- 28 Aug 2023
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data to be shared will include: patient demographics, vital signs, medical history, clinical laboratory tests, examination results, non-medication treatments (surgeries, procedures), physical examinations, and any adverse events related or unrelated to the investigational product, maximum tolerable dose (MTD), dose-limiting toxicities (DLT), all diagnoses, etc. All secondary outcomes (biomarkers, tumor size). All sensitive information will be secured using compliant encryption software and adequate physical security and operational controls. To de-identify the data, codes that participants will be removed from the data set and birth date will be converted to age to avoid "deductive disclosure" of participants. The Principal Investigator will make the final, de-identified, study data set and associated documentation available to the statistician. The study team will develop a data sharing agreement that provides for a commitment to using the data only for research purposes.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2A Pilot Trial of Metformin, Digoxin, Simvastatin (C3) in Combination With Gemcitabine in Subjects With Recurrent / Refractory Metastatic Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06030622
- Acronym / sponsor ID
- C3 / 1727019-4
- Conditions
- Pancreatic Cancer Metastatic
- Keywords
- C3 trial, metformin, simvastatin, digoxin, pancreatic cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- State University of New York - Downstate Medical CenterUniversity, hospital or other
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background. Pancreatic Ductal Adenocarcinoma (PDAC) is one of the deadliest cancers and ranks fourth in cancer-related deaths in the United States. It is among the 10 most commonly diagnosed cancers (9th in women and 10th in men), with approximately 56,770 new cases and 45,750 deaths in 2019. Current therapy for advanced disease includes the use of medications such as Gemcitabine, Erlotinib, Capecitabine, or combination treatments such as 5-fluorouracil, irinotecan, and oxaliplatin; or Gemcitabine and nab-paclitaxel. These standard of care medications have a survival advantage of less than six months in patients with advanced metastatic disease. Recent studies have shown that the use of metformin and simvastatin in 15,099 patients with pancreatic cancer significantly improved their survival.
Study Design/Methods. Based on those prior studies, the investigators will conduct an open-label, single-center, phase 2, feasibility trial of a combined metformin, digoxin, and simvastatin (C3) in 25 subjects with recurrent/refractory metastatic pancreatic cancer in order to evaluate their safety and tolerability. Patients who were previously treated for advanced pancreatic disease with no significant improvements in their disease, will be enrolled in this trial. C3 will be given as oral pills as described in recommended package insert safe levels in addition to their standard of care medication, Gemcitabine.
Study Interventions/Treatment Plan. The treatment plan is as follows: The first 3 patients enrolled in the study, will receive metformin (850 mg twice a day), digoxin (0.25 mg once a day), and simvastatin (20 mg once a day) for 28 days. If no toxic effects, the remaining 22 patients will be enrolled. Patients will be provided C3 medications every 28 days and will continue on the C3 medication for at least 2 years, or until death or recurrence/advancement of the disease. If more than one patient develops a toxic event, the dose will be reduced to metformin 850 mg/day, simvastatin 5 mg/day, and digoxin 0.0625 mg/day. If no further toxicities, then the remaining patients will receive the lower dose. If however, more than two patients develop a toxic event, then study discontinuation will be considered. If patients decline first line treatment (Gemcitabine), they will be offered a choice of C3 medications only.
Safety and Disease Response Assessments. During the conduct of the study, safety assessments will be conducted including physical examination, vital signs monitoring, performance status evaluation, blood CBC/serum chemistry, digoxin levels, toxicity assessment, and radiological tumor assessment. Disease response will be assessed using radiologic tumor assessments, and levels of biomarkers.
Objectives and Endpoints. The Primary Objectives are: 1) To evaluate the safety and tolerability of C3 administration with Gemcitabine. Endpoint and Outcome Measures: Adverse events and abnormalities in laboratory test values, markedly abnormal vital sign measurements; and 2) To assess disease response following C3 administration with Gemcitabine. Endpoint and Outcome Measures: Radiologic tumor assessment at baseline and quarterly thereafter. The Secondary Objectives are: 1) To assess levels of tumor biomarkers. Endpoint and Outcome Measures: Biomarker levels will be determined at baseline and at 2 months after C3 treatment; and 2) To assess molecular changes in biomarkers induced by C3 administration. Endpoint and Outcome Measures: Molecular expressions of tumor biomarkers such as BIRC5, CA19-9, and CEA at baseline, and 2 months after C3 treatment.
Given the safety profile of C3 in thousands of patients, the investigators anticipate that it will significantly improve the disease outcomes and prolong the lives of patients with metastatic advanced pancreatic cancer.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The treatment plan is as follows: The first 3 patients enrolled in the study, will receive metformin (850 mg twice a day), digoxin (0.25 mg once a day), and simvastatin (20 mg once a day) for 28 days. If no toxic effects, the remaining 22 patients will be enrolled. Patients will be provided C3 medications every 28 days and will continue on the C3 medication for at least 2 years, or until death or recurrence/advancement of the disease. If more than one patient develops a toxic event, the dose will be reduced to metformin 850 mg/day, simvastatin 5 mg/day, and digoxin 0.0625 mg/day. If no further toxicities, then the remaining patients will receive the lower dose. If however, more than two patients develop a toxic event, then study discontinuation will be considered. If patients decline first line therapy (Gemcitabine), they will be offered the choice of C3 medications only.
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine and C3 (Combination Digoxin, Simvastatin, and Metformin) | Experimental | Drug: Gemcitabine and C3 (Metformin, Simvastatin, and Digoxin)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. |
| C3 (Combination Digoxin, Simvastatin, and Metformin) only | Experimental | Drug: C3 (Metformin, Simvastatin, and Digoxin) onlyStudy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gemcitabine and C3 (Metformin, Simvastatin, and Digoxin)Also: Glucophage, Zocor, Digitalis, GemzarCombination treatment of Metformin, Simvastatin and Digoxin with Gemcitabine (Arm 1) | Drug | Gemcitabine and C3 (Combination Digoxin, Simvastatin, and Metformin) |
| C3 (Metformin, Simvastatin, and Digoxin) onlyAlso: Glucophage, Zocor, DigitalisC3 only (Metformin, Simvastatin, and Digoxin) if patients decline Gemcitabine (Arm 2). | Drug | C3 (Combination Digoxin, Simvastatin, and Metformin) only |
Primary outcome
Primary Outcome: Safety and tolerability
Time frame: 28 days
Number of participants with treatment-related Adverse Events as assessed by CTCAE v4.0
1 secondary outcome
Secondary Outcome: Biomarkers
Time frame: Before and 2 months after C3 treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: Yes. Data to be shared will include: patient demographics, vital signs, medical history, clinical laboratory tests, examination results, non-medication treatments (surgeries, procedures), physical examinations, and any adverse events related or unrelated to the investigational product, maximum tolerable dose (MTD), dose-limiting toxicities (DLT), all diagnoses, etc. All secondary outcomes (biomarkers, tumor size). All sensitive information will be secured using compliant encryption software and adequate physical security and operational controls. To de-identify the data, codes that participants will be removed from the data set and birth date will be converted to age to avoid "deductive disclosure" of participants. The Principal Investigator will make the final, de-identified, study data set and associated documentation available to the statistician. The study team will develop a data sharing agreement that provides for a commitment to using the data only for research purposes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohan Preet, MD principal investigator
SUNY Downstate Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Gemcitabine and C3 (Metformin, Simvastatin, and Digoxin) and C3 (Metformin, Simvastatin, and Digoxin) only in people with Pancreatic Cancer Metastatic, run by State University of New York - Downstate Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seema Chittalae, MD ((718) 221-6594, seema.chittalae@downstate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome: Safety and tolerability (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.