Intracystic Injection of NanoPac® in Subjects With Mucinous Cystic Pancreatic Neoplasms
Condition: Pancreatic Mucinous-Cystic Neoplasm
MeSH terms: Neoplasms; Pancreatic Neoplasms; Neoplasms, Cystic, Mucinous, and Serous
Intervention: NanoPac®
Intervention description: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Open-label, dose rising trial. During the dose escalation phase, subjects will be enrolled in sequential cohorts of NanoPac®. Each cohort will have three subjects, with cohorts enrolled sequentially starting at the lowest concentration. Following DSMB review of the cohort data, the next cohort may begin enrolling, an additional three subjects at the current dose may be enrolled, or, if the first dose does not provide adequate safety and tolerability, the study may be halted. The dose determined to be the most suitable for further evaluation, defined as the highest dose with an acceptable safety and tolerability profile (as determined by the DSMB), will be the dose used in the second phase of the study which will enroll 9 additional subjects. Subjects enrolled in the second phase of the study will also receive a second injection of NanoPac at the same dose 12 weeks after the first NanoPac injection.
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pancreatic cystic neoplasm; pancreatic cyst; pancreatic mucinous cyst; pancreatic neoplasms; digestive system neoplasms; pancreatic diseases; mucinous cystic neoplasm

Summary:

      This study will evaluate intracystic NanoPac® (Sterile Nanoparticulate Paclitaxel)
      administered via endoscopic ultrasound-guided fine needle injection (EUS-FNI) in subjects
      with mucinous cystic pancreatic neoplasms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent;

          -  Patients over the age of 18;

          -  Recently confirmed mucinous cystic pancreatic neoplasm; may be confirmed by presence
             of mucin, cyst fluid carcinoembryonic antigen (CEA) above 192 U/L, or other reliable
             diagnostic means such as endomicroscopy; KRAS analysis may also be performed at the
             discretion of the Investigator;

          -  Unilocular cyst with diameter of at least 1.5 cm but no more than 4 cm;

          -  Normal hematologic, hepatic, and renal function at study entry;

          -  Appropriate steps taken to minimize or avoid the potential for pregnancy for subjects
             of child-bearing potential.*

               -  Note: A female patient is considered to be of childbearing potential unless she
                  has had a hysterectomy, is at least one year postmenopausal or has undergone
                  tubal ligation. For the purposes of this study, adequate birth control includes
                  at least one medically approved and highly effective method of birth control,
                  defined as those which result in a low failure rate (i.e., < 1% per year) when
                  used consistently and correctly, such as implants, injectables and oral
                  contraceptives combined with the use of condoms. Only male patients whose
                  vasectomy has been confirmed by semen analysis at least 3 months after the
                  vasectomy are allowed not to use acceptable contraceptive methods.

        Exclusion Criteria:

          -  Positive cytology indicating malignancy;

          -  Thrombotic or embolic events;

          -  Known hypersensitivity to study agent;

          -  Known drug or alcohol abuse;

          -  Pregnant or breastfeeding women.