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Trial record 2 of 14 for:    canakinumab cancer

A Phase 1B Study of Canakinumab, Spartalizumab, Nab-paclitaxel, and Gemcitabine in Metastatic PC Patients (PanCAN-SR1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04581343
Recruitment Status : Recruiting
First Posted : October 9, 2020
Last Update Posted : January 27, 2021
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Pancreatic Cancer Action Network

Brief Summary:
This study combines canakinumab (ACZ885), a high-affinity human anti-interleukin-1β (IL-1β) monoclonal antibody (mAb), and spartalizumab (PDR001), a mAb directed against human Programmed Death-1 (PD-1), with the chemotherapy combination of gemcitabine and nab-paclitaxel. This study will confirm for this 4-drug combination the tolerable doses, the acceptable safety profile, and the dose to be used for a Phase II combination treatment regimen.

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Ductal Adenocarcinoma Drug: Canakinumab injection; spartalizumab, nab-paclitaxel, gemcitabine Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: A Phase 1B study enrolling 10 patients to find 6 evaluable patients starting at a maximum dose and dose reducing if needed.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1B Study to Determine the Safety and Tolerability and Confirm the Dose of Canakinumab and Spartalizumab in Combination With Nab-paclitaxel and Gemcitabine for Patients With Metastatic Pancreatic Cancer
Actual Study Start Date : November 2, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2022


Arm Intervention/treatment
Experimental: Canakinumab, spartalizumab, nab-paclitaxel and gemcitabine
Spartalizumab (PDR001),IV infusion, 400 mg, D1 of each 28-day cycle; Canakinumab (ACZ885), s.c. injection, 250 mg, Day 1 of each 28- day cycle; Gemcitabine, IV Infusion, 1000 mg/m2, Days 1, 8, 15 of each 28-day cycle; Nab-paclitaxel, IV Infusion, 125 mg/m2, Days 1, 8, 15 of each 28-day cycle.
Drug: Canakinumab injection; spartalizumab, nab-paclitaxel, gemcitabine
Canakinumab 250 mg s.c. injection; Spartalizumab 400 mg IV infusion, nab-paclitaxel 125 mg/m2 IV infusion, gemcitabine 1000 mg/m2 IV infusion
Other Names:
  • Ilaris
  • Abraxane




Primary Outcome Measures :
  1. Confirm the recommended Phase 2/3 dose of canakinumab, spartalizumab, nab-paclitaxel and gemcitabine in patients with metastatic pancreatic cancer [ Time Frame: Assess the incidence of dose limiting toxicities (DLT) in the first 56 days (8 weeks) of dosing ]
    Confirm the recommended Phase 2/3 dose of canakinumab, spartalizumab, nab-paclitaxel and gemcitabine in patients with metastatic pancreatic cancer


Secondary Outcome Measures :
  1. Determine the Safety [Frequency and severity of (S)AEs, Lab abnormalities and ECGs] of canakinumab, spartalizumab, nab-paclitaxel and gemcitabine in patients with metastatic pancreatic cancer [ Time Frame: From Day 1 of study treatment through Safety Follow-up period (150-days after the last study treatment) ]
    Determine the Safety [Frequency and severity of (S)AEs, Lab abnormalities and ECGs] of canakinumab, spartalizumab, nab-paclitaxel and gemcitabine

  2. Determine the Tolerability [Frequency of dose interruptions and dose reductions] of canakinumab, spartalizumab, nab-paclitaxel and gemcitabine in patients with metastatic pancreatic cancer [ Time Frame: From Day 1 of study treatment through End of Treatment visit, an average of 6 months ]
    Determine the Tolerability [Frequency of dose interruptions and dose reductions] of canakinumab, spartalizumab, nab-paclitaxel and gemcitabine

  3. Determine the response-related efficacy assessments Objective Response Rate (ORR) and Duration of Response (DOR) of canakinumab, spartalizumab, nab-paclitaxel and gemcitabine in patients with metastatic pancreatic cancer [ Time Frame: Tumor response data from CT/MRI scans will be taken at screening visit and every 8 weeks throughout study treatment, an average of 6 months; ]
    Objective Response Rate (ORR) and Duration of Response (DOR) are calculated based on tumor response data [complete Response (CR) and Partial Response (PR)] assessed at the local site using RECIST 1.1 Criteria of patients treated with canakinumab, spartalizumab, nab-paclitaxel and gemcitabine

  4. Determine the Disease Control Rate (DCR) of canakinumab, spartalizumab, nab-paclitaxel and gemcitabine in patients with metastatic pancreatic cancer [ Time Frame: Tumor response data from CT/MRI scans will be taken at screening visit and every 8 weeks throughout study treatment, an average of 6 months; ]
    The Disease Control Rate (DCR) is calculated based on tumor response data [complete Response (CR) and Partial Response (PR) and Stable Disease (SD)] assessed at the local site using RECIST 1.1 Criteria of patients treated with canakinumab, spartalizumab, nab-paclitaxel and gemcitabine

  5. Determine the Progression Free Survival (PFS) of canakinumab, spartalizumab, nab-paclitaxel and gemcitabine in patients with metastatic pancreatic cancer [ Time Frame: Tumor response data from CT/MRI scans will be taken at screening visit and every 8 weeks throughout study treatment, an average of 6 months; ]
    The Progression Free Survival is defined as the time from the date of the first dose to the date of disease progression, assessed at the local site using RECIST 1.1 Criteria, of patients treated with canakinumab, spartalizumab, nab-paclitaxel and gemcitabine

  6. Determine the Time To Response Rate (TTR) of canakinumab, spartalizumab, nab-paclitaxel and gemcitabine in patients with metastatic pancreatic cancer [ Time Frame: Tumor response data from CT/MRI scans will be taken at screening visit and every 8 weeks throughout study treatment, an average of 6 months; ]
    The TIme To Response Rate is defined as the time from the date of the first dose to the date of first documented tumor response [Complete Response (CR) or Partial Response (PR)], assessed at the local site using RECIST 1.1 Criteria, of patients treated with canakinumab, spartalizumab, nab-paclitaxel and gemcitabine

  7. Determine the Overall Survival (OS) of canakinumab, spartalizumab, nab-paclitaxel and gemcitabine in patients with metastatic pancreatic cancer [ Time Frame: Overall Survival assessment will be from first day of study treatment to subject's date of death, or until study closure, assessed up to 24 months; ; ]
    The Overall Survival is defined as the time from the date of the first dose to the date of death, due to any cause, of patients treated with canakinumab, spartalizumab, nab-paclitaxel and gemcitabine

  8. Characterize the pharmacokinetics of canakinumab in patients with metastatic pancreatic cancer [ Time Frame: Pharmacokinetic (PK) blood draws will be taken during cycles 1-6 for canakinumab analyte; Every cycle is 28-days, total estimated time is 6 months; ]
    Characterize the Descriptive Statistics (n, m (number of non-zero concentrations), mean, coefficient of variation CV%, SD, median, geometric mean, geometric CV%, minimum and maximum) of the Pharmacokinetic (PK) blood samples of patients treated with canakinumab, spartalizumab, nab-paclitaxel and gemcitabine;

  9. Characterize the pharmacokinetics of spartalizumab in patients with metastatic pancreatic cancer [ Time Frame: Pharmacokinetic (PK) blood draws will be taken during cycles 1-6 for spartalizumab analyte; Every cycle is 28-days, total estimated time is 6 months; ]
    Characterize the Descriptive Statistics (n, m (number of non-zero concentrations), mean, coefficient of variation CV%, SD, median, geometric mean, geometric CV%, minimum and maximum) of the Pharmacokinetic (PK) blood samples of patients treated with canakinumab, spartalizumab, nab-paclitaxel and gemcitabine;

  10. Characterize the pharmacokinetics of nab-paclitaxel in patients with metastatic pancreatic cancer [ Time Frame: Pharmacokinetic (PK) blood draws will be taken during cycles 1 and 2 for nab-paclitaxel analyte; Every cycle is 28-days, total estimated time is 2 months; ]
    Characterize the Descriptive Statistics (n, m (number of non-zero concentrations), mean, coefficient of variation CV%, SD, median, geometric mean, geometric CV%, minimum and maximum) of the Pharmacokinetic (PK) blood samples of patients treated with canakinumab, spartalizumab, nab-paclitaxel and gemcitabine;

  11. Characterize the pharmacokinetics of gemcitabine in patients with metastatic pancreatic cancer [ Time Frame: Pharmacokinetic (PK) blood draws will be taken during cycles 1 and 2 for gemcitabine analyte; Every cycle is 28-days, total estimated time is 2 months; ]
    Characterize the Descriptive Statistics (n, m (number of non-zero concentrations), mean, coefficient of variation CV%, SD, median, geometric mean, geometric CV%, minimum and maximum) of the Pharmacokinetic (PK) blood samples of patients treated with canakinumab, spartalizumab, nab-paclitaxel and gemcitabine;


Other Outcome Measures:
  1. Study the immunogenicity [by tabulating the Anti-drug Antibodies (ADA) prevalence at baseline and ADA incidence on-treatment] of canakinumab, and spartalizumab combined with nab-paclitaxel and gemcitabine in metastatic pancreatic cancer patients [ Time Frame: Immunogenicity Samples of canakinumab analytes are taken during Cycles 1-6 of study treatment; Every cycle is 28-days, total estimated time is 6 months; ]
    Study the immunogenicity [by tabulating the Anti-drug Antibodies (ADA) prevalence at baseline and ADA incidence on-treatment] of patients treated with canakinumab;

  2. Study the immunogenicity [by tabulating the Anti-drug Antibodies (ADA) prevalence at baseline and ADA incidence on-treatment] of canakinumab, and spartalizumab combined with nab-paclitaxel and gemcitabine in metastatic pancreatic cancer patients [ Time Frame: Immunogenicity Samples of spartalizumab analytes are taken during Cycles 1-6 of study treatment; Every cycle is 28-days, total estimated time is 6 months; ]
    Study the immunogenicity [by tabulating the Anti-drug Antibodies (ADA) prevalence at baseline and ADA incidence on-treatment] of patients treated with spartalizumab;

  3. Study the immune modulation effect of this 4-drug combination on the tumor micro-environment using sample analysis from tissue biopsies. [ Time Frame: Tissue samples will be taken at two timepoints: at baseline visit (Prior to treatment) and after 8-weeks of study treatment; ]
    Study the immune modulation effect of this 4-drug combination on the tumor micro-environment from tissue biopsies, and analyzed for genomic analyses (RNA and DNA sequencing);

  4. Study the immune modulation effect of this 4-drug combination on the tumor micro-environment using immunostaining from tissue biopsies. [ Time Frame: Tissue samples will be taken at two timepoints: at baseline visit (Prior to treatment) and after 8-weeks of study treatment; ]
    Study the immune modulation effect of this 4-drug combination on the tumor micro-environment from tissue biopsies, and analyzed for immunostaining;

  5. Study the immune modulation effect of this 4-drug combination on the tumor micro-environment using flow cytometry from tissue biopsies. [ Time Frame: Tissue samples will be taken at two timepoints: at baseline visit (Prior to treatment) and after 8-weeks of study treatment; ]
    Study the immune modulation effect of this 4-drug combination on the tumor micro-environment from tissue biopsies, and analyzed for flow cytometry;

  6. Study the immune modulation effect of this 4-drug combination on the tumor micro-environment using CyTOF analysis from tissue biopsies. [ Time Frame: Tissue samples will be taken at two timepoints: at baseline visit (Prior to treatment) and after 8-weeks of study treatment; ]
    Study the immune modulation effect of this 4-drug combination on the tumor micro-environment from tissue biopsies, and analyzed for CyTOF;

  7. Study the immune modulation effect of this 4-drug combination on the tumor micro-environment using single-cell RNA sequencing from tissue biopsies. [ Time Frame: Tissue samples will be taken at two timepoints: at baseline visit (Prior to treatment) and after 8-weeks of study treatment; ]
    Study the immune modulation effect of this 4-drug combination on the tumor micro-environment from tissue biopsies, and analyzed for single-cell RNA sequencing;

  8. To study IL-1B signaling by measuring IL-6 and CRP in serum in human Pancreatic Ductal Adenocarcinoma (PDAC) [ Time Frame: Blood samples for these analyses will be collected during Days 1 and 15 of every treatment Cycle, on Day 8 of cycle 1, and End of Treatment Visit, an average of 6 months; ; ]
    IL-1B signaling in human PDAC will be analyzed by measuring IL-6 and CRP in serum;

  9. To study IL-1B signaling by performing ctDNA analysis in human Pancreatic Ductal Adenocarcinoma (PDAC) [ Time Frame: Blood samples for these analyses will be collected during Days 1 and 15 of every treatment Cycle, on Day 8 of cycle 1, and End of Treatment Visit, an average of 6 months; ; ]
    IL-1B signaling in human PDAC will be analyzed by performing ctDNA analysis;

  10. To study IL-1B signaling by measuring a panel of cancer-related cytokines in plasma in human Pancreatic Ductal Adenocarcinoma (PDAC) [ Time Frame: Blood samples for these analyses will be collected during Days 1 and 15 of every treatment Cycle, on Day 8 of cycle 1, and End of Treatment Visit, an average of 6 months; ; ]
    IL-1B signaling in human PDAC will be analyzed by measuring a panel of cancer-related cytokines in plasma;

  11. To study IL-1B signaling by isolating leukocytes in human Pancreatic Ductal Adenocarcinoma (PDAC) [ Time Frame: Blood samples for these analyses will be collected during Days 1 and 15 of every treatment Cycle, on Day 8 of cycle 1, and End of Treatment Visit, an average of 6 months; ; ]
    IL-1B signaling in human PDAC will be analyzed by the isolation of leukocytes;

  12. To study IL-1B signaling by performing flow cytometry in human Pancreatic Ductal Adenocarcinoma (PDAC) [ Time Frame: Blood samples for these analyses will be collected during Days 1 and 15 of every treatment Cycle, on Day 8 of cycle 1, and End of Treatment Visit, an average of 6 months; ; ]
    IL-1B signaling in human PDAC will be analyzed by flow cytometry;



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years at the time of informed consent
  • Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC) (determined by a local laboratory) with metastatic spread of disease (adenosquamous is also allowed).
  • Patients must have not received previous anti-cancer therapy for the treatment of metastatic pancreatic ductal adenocarcinoma.
  • Patients who received previous neo-/adjuvant systemic therapy for non-metastatic PDAC ≥12 months from the last treatment to study enrollment date are allowed unless this therapy included immunotherapy and/or IL-1 inhibitors.
  • Radiographically measurable disease of at least one site by computed tomography (CT) scan (or magnetic resonance imaging, if allergic to CT contrast media) as defined by Response Evaluation Criteria In Solid Tumors (RECIST 1.1). Primary lesion is allowed as long as it is measurable (per RECIST 1.1) and has not been previously irradiated. Imaging results must be obtained within the 28-day screening window.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Adequate organ function (laboratory results must be obtained within the 28-day screening window)

    • Absolute neutrophil count > 1500/mm3
    • Hemoglobin > 9 g/dL
    • Platelets > 100,000/mm3
    • Serum creatinine < 1.5 x upper limit normal (ULN), or calculated creatinine clearance > 60 mL/min (Cockcroft Gault)
    • Albumin > 3.0 g/dL
    • Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT) and/or alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) < 3.0 x ULN (< 5 x ULN in presence of liver metastasis).

In patients with elevated ALT or AST, the values must be stable for at least 2 weeks and with no evidence of biliary obstruction on imaging

  • Total bilirubin ≤ 1.5 X ULN
  • INR ≤ 1.5 x ULN

    • Consent to provide protocol-mandated tissue and blood samples for diagnostic, PK, and research purposes
    • Able to adhere to study visit schedule and other protocol requirements

Exclusion Criteria:

  • Diagnosis of pancreatic neuroendocrine carcinoma or pancreatic acinar cell carcinoma
  • Previous immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways).
  • Known microsatellite instability-high (MSI-H) or mismatch repair-deficient pancreatic cancer
  • Prior treatment with canakinumab or drugs of a similar mechanism of action (IL-1 inhibitor).
  • History of known hypersensitivity to any of the drugs used in this study or any of their excipients, or patient has contraindication to any of the study drugs as outlined in the local prescribing information (e.g. United States Prescribing Information [USPI])
  • Active autoimmune disease that has required systemic treatment in the past 2 years prior to enrollment i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs. Control of the disorder with replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is permitted.
  • Patient with suspected or proven immunocompromised state or infections, including:

    • Evidence of active or latent tuberculosis (TB) as determined by locally approved screening methods. If the results of the screening per local treatment guidelines or clinical practice require treatment, then the patient is not eligible.
    • Chronic or active hepatitis B or C
    • Known history of testing positive for Human Immunodeficiency Virus (HIV) infections.
    • Any other medical condition (such as active infection, treated or untreated), which in the opinion of the investigator places the patient at an unacceptable risk for participation in immunomodulatory therapy.

Note: Patients with localized condition unlikely to lead to a systemic infection e.g. chronic nail fungal infection are eligible.

  • Allogeneic bone marrow or solid organ transplant
  • Treatment with any immune modulating agent in doses with systemic effects e.g.:

    • Systemic treatment with prednisone > 10 mg (or equivalent) for >14 days within 4 weeks prior to the first dose of study treatment.
    • Equivalent dose of methotrexate > 15 mg weekly
    • Patient receiving any biologic drugs targeting the immune system (for example, TNF blockers, anakinra, rituximab, abatacept, or tocilizumab).
    • Note: Daily glucocorticoid-replacement for conditions such as adrenal or pituitary insufficiency is allowed.
    • Note: Topical, inhaled, or local steroid use in doses that are not considered to cause systemic effects are permitted (based on investigator's discretion and consultation with the Medical Monitor if needed).
  • Patient has concurrent malignancy other than the disease under investigation, with exception of malignancy that was treated curatively and has not recurred within 2 years prior to the date of screening. Fully resected basal or squamous cell skin cancers, and any carcinoma in situ are eligible.
  • Uncontrolled or severe cardiac disease (history of unstable angina, myocardial infarction, coronary stenting, or bypass surgery within the prior 6 months), symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia [including atrial flutter/fibrillation], requirement for inotropic support or use of devices for cardiac conditions [pacemakers/defibrillators]), uncontrolled hypertension defined by a systolic blood pressure =>160 mg and/or diastolic blood pressure =>100 mg Hg
  • Pre-existing peripheral neuropathy > Grade 1 (CTCAE V 5.0)
  • Receipt of live vaccines within 3 months prior to the first dose of study treatment or while on active treatment within the trial (examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and typhoid (oral vaccine). Seasonal influenza vaccines for injection are generally killed virus vaccines and are permitted. However, intranasal influenza vaccines (e.g. Flu-mist) are live attenuated vaccines and are not permitted.
  • Patient has had major surgery within 14 days prior to enrollment
  • Patient has symptomatic brain metastases, or brain metastases that require directed therapy (such as focal radiotherapy or surgery). Patients with treated brain metastases have to be neurologically stable and not using systemic steroids for at least 4 weeks prior to the study drug administration.
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are willing to use highly effective methods of contraception during treatment with study drugs (canakinumab, spartalizumab, gemcitabine and nab-paclitaxel).
  • Highly effective contraception methods are required while on treatment and for 150 days after stopping spartalizumab. No contraception is required after treatment with canakinumab is stopped. Contraception use after chemotherapy is stopped should be followed per the local drug label requirements.

Highly effective contraception methods include:

  • Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (i.e., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception
  • Female sterilization (have had bilateral surgical oophorectomy (with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
  • Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that patient.
  • Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.

Note: Women of non-childbearing potential is defined as women who are physiologically and/or anatomically incapable of becoming pregnant, as now further described:

  • They are post-menopausal as evidenced by 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e., age appropriate history of vasomotor symptoms).
  • They have had bilateral surgical oophorectomy (with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least six weeks prior. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of childbearing potential.

Note: Sexually active male patients and their partners who are women of childbearing potential should follow the contraception recommendations and any other precautionary measures as required by the local prescribing information for the SOC anti-cancer.

  • Any significant medical condition, laboratory abnormality or psychiatric condition that would constitute unacceptable safety risks to the patients, contraindicate patient participation in the clinical study, limit the patient's ability to comply with study requirements, or compromise patient's compliance with the protocol and all requirements of the study as stated in the Informed Consent Form. Significant medical conditions include but are not limited to known history or current interstitial lung disease or non-infectious pneumonitis, medical history or current diagnosis of myocarditis, chronic active hepatitis, liver cirrhosis or any other significant liver disease with moderate to severe hepatic impairment (Child-Pugh B or C), serious non-healing wound/ulcer/bone fracture, uncompensated/symptomatic hypothyroidism, or requirement for hemodialysis or peritoneal dialysis.
  • Unwillingness or unable to comply with all requirement of the study as stated in the Informed Consent Form

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04581343


Contacts
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Contact: Amy Stoll-D'Astice, MS 602-570-2383 astoll-dastice@pancan.org
Contact: Regina Deck, RN, MSN, OCN 310-706-3507 rdeck@pancan.org

Locations
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United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Gastrointestinal Clinical Research Line    617-632-5960      
Principal Investigator: Osama Rahma, MD         
United States, New York
New York University Recruiting
New York, New York, United States, 10016
Contact: Benson Joseph    212-731-5076    benson.joseph@nyumc.org   
Principal Investigator: Paul Oberstein, MD         
Sponsors and Collaborators
Pancreatic Cancer Action Network
Novartis Pharmaceuticals
Investigators
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Study Director: Regina Deck, RN, MSN, OCN Pancreatic Cancer Action Network
Publications:
FDA, Challenges and Opportunities Report. Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products. March 2004.
Spiegelhalter, DJ. Incorporating Bayesian Ideas into Health-Care Evaluation. Statistical Science, 2004. 19(1), 156-174.

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Responsible Party: Pancreatic Cancer Action Network
ClinicalTrials.gov Identifier: NCT04581343    
Other Study ID Numbers: PanCAN-SR1
First Posted: October 9, 2020    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Gemcitabine
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs