xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06030622</url>
    </required_header>
    <id_info>
      <org_study_id>1727019-4</org_study_id>
      <nct_id>NCT06030622</nct_id>
    </id_info>
    <brief_title>Phase 2A Pilot C3 Trial of Recurrent/Refractory Metastatic Advanced Pancreatic Cancer</brief_title>
    <acronym>C3</acronym>
    <official_title>Phase 2A Pilot Trial of Metformin, Digoxin, Simvastatin (C3) in Combination With Gemcitabine in Subjects With Recurrent / Refractory Metastatic Advanced Pancreatic Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>State University of New York - Downstate Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>State University of New York - Downstate Medical Center</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goals of this trial are: 1) To evaluate the safety and tolerability of C3 administration&#xD;
        with Gemcitabine; and 2) To assess the disease response following C3 administration with&#xD;
        Gemcitabine. The main question it aims to answer are: 1) Is C3 in combination with&#xD;
        Gemcitabine safe, tolerable, and effective for reducing improving advanced stage pancreatic&#xD;
        cancer? and 2) Can C3 in combination with Gemcitabine prolong the lives of patients with&#xD;
        advanced stage pancreatic cancer. Participants will receive a combination of metformin (850&#xD;
        mg twice a day), digoxin (0.25 mg once a day), and simvastatin (20 mg once a day), also known&#xD;
        as C3, and Gemcitabine (as per standard of care) for 2 years.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background. Pancreatic Ductal Adenocarcinoma (PDAC) is one of the deadliest cancers and ranks&#xD;
        fourth in cancer-related deaths in the United States. It is among the 10 most commonly&#xD;
        diagnosed cancers (9th in women and 10th in men), with approximately 56,770 new cases and&#xD;
        45,750 deaths in 2019. Current therapy for advanced disease includes the use of medications&#xD;
        such as Gemcitabine, Erlotinib, Capecitabine, or combination treatments such as&#xD;
        5-fluorouracil, irinotecan, and oxaliplatin; or Gemcitabine and nab-paclitaxel. These&#xD;
        standard of care medications have a survival advantage of less than six months in patients&#xD;
        with advanced metastatic disease. Recent studies have shown that the use of metformin and&#xD;
        simvastatin in 15,099 patients with pancreatic cancer significantly improved their survival.&#xD;
  &#xD;
        Study Design/Methods. Based on those prior studies, the investigators will conduct an&#xD;
        open-label, single-center, phase 2, feasibility trial of a combined metformin, digoxin, and&#xD;
        simvastatin (C3) in 25 subjects with recurrent/refractory metastatic pancreatic cancer in&#xD;
        order to evaluate their safety and tolerability. Patients who were previously treated for&#xD;
        advanced pancreatic disease with no significant improvements in their disease, will be&#xD;
        enrolled in this trial. C3 will be given as oral pills as described in recommended package&#xD;
        insert safe levels in addition to their standard of care medication, Gemcitabine.&#xD;
  &#xD;
        Study Interventions/Treatment Plan. The treatment plan is as follows: The first 3 patients&#xD;
        enrolled in the study, will receive metformin (850 mg twice a day), digoxin (0.25 mg once a&#xD;
        day), and simvastatin (20 mg once a day) for 28 days. If no toxic effects, the remaining 22&#xD;
        patients will be enrolled. Patients will be provided C3 medications every 28 days and will&#xD;
        continue on the C3 medication for at least 2 years, or until death or recurrence/advancement&#xD;
        of the disease. If more than one patient develops a toxic event, the dose will be reduced to&#xD;
        metformin 850 mg/day, simvastatin 5 mg/day, and digoxin 0.0625 mg/day. If no further&#xD;
        toxicities, then the remaining patients will receive the lower dose. If however, more than&#xD;
        two patients develop a toxic event, then study discontinuation will be considered.&#xD;
  &#xD;
        Safety and Disease Response Assessments. During the conduct of the study, safety assessments&#xD;
        will be conducted including physical examination, vital signs monitoring, performance status&#xD;
        evaluation, blood CBC/serum chemistry, digoxin levels, toxicity assessment, and radiological&#xD;
        tumor assessment. Disease response will be assessed using radiologic tumor assessments, and&#xD;
        levels of biomarkers.&#xD;
  &#xD;
        Objectives and Endpoints. The Primary Objectives are: 1) To evaluate the safety and&#xD;
        tolerability of C3 administration with Gemcitabine. Endpoint and Outcome Measures: Adverse&#xD;
        events and abnormalities in laboratory test values, markedly abnormal vital sign&#xD;
        measurements; and 2) To assess disease response following C3 administration with Gemcitabine.&#xD;
        Endpoint and Outcome Measures: Radiologic tumor assessment at baseline and quarterly&#xD;
        thereafter. The Secondary Objectives are: 1) To assess levels of tumor biomarkers. Endpoint&#xD;
        and Outcome Measures: Biomarker levels will be determined at baseline and at 2 months after&#xD;
        C3 treatment; and 2) To assess molecular changes in biomarkers induced by C3 administration.&#xD;
        Endpoint and Outcome Measures: Molecular expressions of tumor biomarkers such as BIRC5,&#xD;
        CA19-9, and CEA at baseline, and 2 months after C3 treatment.&#xD;
  &#xD;
        Given the safety profile of C3 in thousands of patients, the investigators anticipate that it&#xD;
        will significantly improve the disease outcomes and prolong the lives of patients with&#xD;
        metastatic advanced pancreatic cancer.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 11, 2023</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
    <phase>Phase 1/Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_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.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Primary Outcome: Safety and tolerability</measure>
      <time_frame>28 days</time_frame>
      <description>Number of participants with treatment-related Adverse Events as assessed by CTCAE v4.0</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Secondary Outcome: Biomarkers</measure>
      <time_frame>Before and 2 months after C3 treatment</time_frame>
      <description>Tumor biomarkers as assessed by levels of BIRC5, CA19-9, CEA.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Pancreatic Cancer Metastatic</condition>
    <arm_group>
      <arm_group_label>C3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Study participants will receive metformin (850 mg twice a day), digoxin (0.25 mg once a day), and simvastatin (20 mg once a day) combination (C3) and Gemcitabine for up to 2 years.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>C3 (Metformin, Simvastatin, and Digoxin)</intervention_name>
      <description>Combination treatment of Metformin, Simvastatin and Digoxin, with standard of care Gemcitabine.</description>
      <arm_group_label>C3</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Subject ≥18 years with histologically confirmed pancreatic cancer.&#xD;
  &#xD;
            2. Refractory, intolerant to, or with disease progression after at least one standard of&#xD;
               care regimen.&#xD;
  &#xD;
            3. ECOG performance status (PS) 0-1.&#xD;
  &#xD;
            4. Pretreatment biopsy and/or adequate archival tissue available for BIRC5 protein level&#xD;
               evaluation.&#xD;
  &#xD;
            5. Adequate organ and marrow function: absolute granulocyte count ≥1,000/mm3, platelets&#xD;
               ≥100,000/mm3, total bilirubin ≤ institutional upper normal limit, AST/ALT ≤2x&#xD;
               institutional upper limit of normal, and creatinine &lt;1.5 mg/dL or calculated&#xD;
               creatinine clearance &gt; 60ml / min (Cockcroft-Gault Equation).&#xD;
  &#xD;
            6. Subject has recovered to CTCAE Grade 1 (except for alopecia) or better from all&#xD;
               adverse events associated with prior therapy or surgery. Pre-existing motor or sensory&#xD;
               neurologic pathology or symptoms must be recovered to CTCAE Grade 2 or better.&#xD;
  &#xD;
            7. If participant of childbearing potential, has a negative urine or serum pregnancy&#xD;
               test. If the urine test is positive or cannot be confirmed as negative, a negative&#xD;
               serum test will be required for study entry. Serum pregnancy tests will be conducted&#xD;
               at the time of screening, when other blood draws are obtained (See Appendix III:&#xD;
               Time-Table of Procedures).&#xD;
  &#xD;
            8. Ability to understand and the willingness to sign a written informed protocol specific&#xD;
               consent.&#xD;
  &#xD;
            9. Willing and able to comply with the protocol for the duration of the study including&#xD;
               undergoing treatment and scheduled visits and examinations including follow up.&#xD;
  &#xD;
           10. No known active infections at the time of enrollment as determined by negative&#xD;
               procalcitonin level.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Anti-cancer chemotherapy, biologic therapy or immunotherapy within 3 weeks or&#xD;
               radiation therapy within 2 weeks of first investigational product administration.&#xD;
  &#xD;
            2. Known history of other malignancy unless having undergone curative intent therapy&#xD;
               without evidence of that disease for ≥ 3 years except cutaneous squamous cell and&#xD;
               basal cell skin cancer, superficial bladder cancer, in situ cervical cancer or other&#xD;
               in situ cancers are allowed if definitively resected.&#xD;
  &#xD;
            3. Brain metastases unless treated with curative intent (gamma knife or surgical&#xD;
               resection) and without evidence of progression for ≥ 2 months.&#xD;
  &#xD;
            4. Known history of rhabdomyolysis.&#xD;
  &#xD;
            5. History of or current evidence of any condition (including medical, psychiatric or&#xD;
               substance abuse disorder), therapy, or laboratory abnormality that might confound the&#xD;
               results of the study, interfere with the subject's participation for the full duration&#xD;
               of the study, or is not in the best interest of the subject to participate, in the&#xD;
               opinion of the Investigator.&#xD;
  &#xD;
            6. Known chronic Hepatitis B or C infection.&#xD;
  &#xD;
            7. Have current active infection requiring systemic antibiotic treatment.&#xD;
  &#xD;
            8. History of severe allergic, anaphylactic, hypersensitivity reactions or previous&#xD;
               intolerance to Metformin, Simvastatin, and/or Digoxin.&#xD;
  &#xD;
            9. Patients with significant cardiac disease or condition listed below (unless clearance&#xD;
               obtained by cardiology):&#xD;
  &#xD;
                 1. Wolff-Parkinson-White Syndrome.&#xD;
  &#xD;
                 2. Previous MI within last 6 months of C1D1.&#xD;
  &#xD;
                 3. Evidence of residual electrographic pattern consistent with heart block., for&#xD;
                    example atrio-ventricular (AV) heart block (currently ongoing).&#xD;
  &#xD;
                 4. History of ventricular fibrillation.&#xD;
  &#xD;
                 5. Sick Sinus Syndrome or Sinus bradycardia thought to be caused by sinus node&#xD;
                    disease, unless effectively treated.&#xD;
  &#xD;
                 6. Heart failure with preserved LVEF, including constructive pericarditis, and&#xD;
                    amyloid heart disease.&#xD;
  &#xD;
           10. Acute cor pulmonale, restrictive cardiomyopathy, and Amyloid heart muscle disease.&#xD;
  &#xD;
           11. Participants of childbearing potential who are found to be pregnant as evidenced by&#xD;
               positive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG)&#xD;
               or nursing.&#xD;
  &#xD;
           12. Any condition that, in the opinion of the investigator, would interfere with&#xD;
               evaluation of study treatment or interpretation of patient safety or trial results.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mohan Preet, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>SUNY Downstate Health Sciences University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mohan Preeet, MD</last_name>
      <phone>(718) 270-1500</phone>
      <email>mohan.preet@downstate.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Moro Salifu, MD</last_name>
      <phone>(718) 270-1584</phone>
      <email>moro.salifu@downstate.edu</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>State University of New York - Downstate Medical Center</investigator_affiliation>
      <investigator_full_name>Mohan Preet</investigator_full_name>
      <investigator_title>Oncologist</investigator_title>
    </responsible_party>
    <keyword>C3 trial</keyword>
    <keyword>metformin</keyword>
    <keyword>simvastatin</keyword>
    <keyword>digoxin</keyword>
    <keyword>pancreatic cancer</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pancreatic Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Metformin</mesh_term>
      <mesh_term>Digoxin</mesh_term>
      <mesh_term>Simvastatin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>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 &quot;deductive disclosure&quot; 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.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>September 30, 2024 to September 30, 2026</ipd_time_frame>
      <ipd_access_criteria>Data will be made available to the general public only through presentations and publications with no identifiers. Data will be shared in continuing education programs at a national and international level. Data will be shared in appropriate forums. All Protected Health Information (PHI) will be restricted to the PI and their research designees. Researchers who seek to obtain data will submit a request to the PI and IRB for approval. However, no PHI will be shared. The PI will ensure that shared data are protected. Data to be transferred for additional analyses will be de-identified and an agreement for confidentiality of data will be obtained from the secondary user who must agree to protect the data. This will include communicating the data protection plan; determining whether the original consent agreement limited the use of the data in future studies; and obtaining a written and binding agreement from the recipient that the data are bound by all of the agreed conditions.</ipd_access_criteria>
      <ipd_url>https://www.downstate.edu</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06030622
  org study id: 1727019-4
  nct id: NCT06030622
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  
        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.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention 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.
  primary purpose: Other
  masking: None (Open Label)
  measure: Primary Outcome: Safety and tolerability
  time frame: 28 days
  description: Number of participants with treatment-related Adverse Events as assessed by CTCAE v4.0
  measure: Secondary Outcome: Biomarkers
  time frame: Before and 2 months after C3 treatment
  description: Tumor biomarkers as assessed by levels of BIRC5, CA19-9, CEA.
  arm group label: C3
  arm group type: Experimental
  description: Study participants will receive metformin (850 mg twice a day), digoxin (0.25 mg once a day), and simvastatin (20 mg once a day) combination (C3) and Gemcitabine for up to 2 years.
  intervention type: Drug
  intervention name: C3 (Metformin, Simvastatin, and Digoxin)
  description: Combination treatment of Metformin, Simvastatin and Digoxin, with standard of care Gemcitabine.
  arm group label: C3
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Mohan Preet, MD
  role: Principal Investigator
  affiliation: SUNY Downstate Health Sciences University
  last name: Mohan Preeet, MD
  phone: (718) 270-1500
  email: mohan.preet@downstate.edu
  last name: Moro Salifu, MD
  phone: (718) 270-1584
  email: moro.salifu@downstate.edu
  responsible party type: Principal Investigator
  investigator affiliation: State University of New York - Downstate Medical Center
  investigator full name: Mohan Preet
  investigator title: Oncologist
  mesh term: Pancreatic Neoplasms
  mesh term: Metformin
  mesh term: Digoxin
  mesh term: Simvastatin
  sharing ipd: Yes
  ipd description: 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.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: September 30, 2024 to September 30, 2026
  ipd access criteria: Data will be made available to the general public only through presentations and publications with no identifiers. Data will be shared in continuing education programs at a national and international level. Data will be shared in appropriate forums. All Protected Health Information (PHI) will be restricted to the PI and their research designees. Researchers who seek to obtain data will submit a request to the PI and IRB for approval. However, no PHI will be shared. The PI will ensure that shared data are protected. Data to be transferred for additional analyses will be de-identified and an agreement for confidentiality of data will be obtained from the secondary user who must agree to protect the data. This will include communicating the data protection plan; determining whether the original consent agreement limited the use of the data in future studies; and obtaining a written and binding agreement from the recipient that the data are bound by all of the agreed conditions.
  ipd url: https://www.downstate.edu