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Intracystic Injection of NanoPac® in Subjects With Mucinous Cystic Pancreatic Neoplasms

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ClinicalTrials.gov Identifier: NCT03188991
Recruitment Status : Completed
First Posted : June 16, 2017
Results First Posted : June 8, 2021
Last Update Posted : June 14, 2021
Sponsor:
Collaborator:
US Biotest, Inc.
Information provided by (Responsible Party):
NanOlogy, LLC

Tracking Information
First Submitted Date  ICMJE June 13, 2017
First Posted Date  ICMJE June 16, 2017
Results First Submitted Date  ICMJE May 12, 2021
Results First Posted Date  ICMJE June 8, 2021
Last Update Posted Date June 14, 2021
Actual Study Start Date  ICMJE September 29, 2017
Actual Primary Completion Date June 29, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2021)
Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability) [ Time Frame: Up to 6 (six) months after first NanoPac® injection ]
Treatment Emergent Adverse Events will include laboratory assessments, physical examination findings, and vital signs.
Original Primary Outcome Measures  ICMJE
 (submitted: June 15, 2017)
Incidence of Treatment Emergent Adverse Events (Safety and Tolerability) [ Time Frame: Uo to 6 (six) months after NanoPac® injection ]
Treatment Emergent Adverse Events will include laboratory assessments, physical examination findings, and vital signs.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2021)
Cyst Volume Response [ Time Frame: Screening and 6 (six) months after first NanoPac® injection ]
Cyst volume at screening will be compared with the volume at Weeks 12 and 24 (or early termination).
Original Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2017)
  • Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) of NanoPac® [ Time Frame: Up to 6 (six) months after NanoPac® injection ]
  • Pharmacokinetics: Peak plasma concentration (Cmax) of NanoPac® [ Time Frame: Up to 6 (six) months after NanoPac® injection ]
  • Pharmacokinetics: Time at which peak plasma concentration is observed (Tmax) of NanoPac® [ Time Frame: Up to 6 (six) months after NanoPac® injection ]
  • Cyst Volume Response [ Time Frame: Screening and 6 (six) months after NanoPac® injection ]
    Cyst volume at screening will be compared with the volume at Weeks 12 and 24 (or early termination).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intracystic Injection of NanoPac® in Subjects With Mucinous Cystic Pancreatic Neoplasms
Official Title  ICMJE A Trial Evaluating Escalating Doses and the Safety of Intracystic Injection of NanoPac® in Subjects With Mucinous Cystic Pancreatic Neoplasms
Brief 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.
Detailed Description

In this open-label, dose rising trial, subjects with mucinous cystic pancreatic neoplasms will receive intracystic NanoPac® via endoscopic ultrasound-guided fine needle injection (EUS-FNI).

In the dose escalation phase, subjects will be enrolled in sequential cohorts of NanoPac® at 6, 10, and 15 mg/mL at volumes sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated. Each cohort will have three subjects, with cohorts enrolled sequentially starting at the lowest concentration. Following Data Safety Monitoring Board (DSMB) review of the cohort data, the next cohort may begin enrolling, an additional three 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..

Plasma samples will be taken on the day(s) of NanoPac® injection at 1 and 2 hours after injection, as well as at each of the subsequent study visits, to characterize the pharmacokinetics (PK) of intracystic NanoPac®.

Subjects will be followed for 6 months after the first NanoPac® injection for safety, tolerability and cyst response to therapy (as shown by imaging).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Mucinous-Cystic Neoplasm
Intervention  ICMJE Drug: NanoPac®
NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)
Study Arms  ICMJE
  • Experimental: Dose Escalation: NanoPac® 6 mg/mL
    Single intracystic injection of NanoPac® at a dose of 6 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated
    Intervention: Drug: NanoPac®
  • Experimental: Dose Escalation: NanoPac® 10 mg/mL
    Single intracystic injection of NanoPac® at a dose of 10 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated
    Intervention: Drug: NanoPac®
  • Experimental: Dose Escalation: NanoPac® 15 mg/mL
    Single intracystic injection of NanoPac® at a dose of 15 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated
    Intervention: Drug: NanoPac®
  • Experimental: Second Phase: NanoPac® at Best Dose
    Intracystic injection of NanoPac®. The dose administered in the second phase will be determined during the dose escalation phase. Subjects will receive two NanoPac® injections, with the second injection administered 12 weeks after the first injection.
    Intervention: Drug: NanoPac®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 12, 2021)
20
Original Estimated Enrollment  ICMJE
 (submitted: June 15, 2017)
30
Actual Study Completion Date  ICMJE June 29, 2020
Actual Primary Completion Date June 29, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03188991
Other Study ID Numbers  ICMJE NANOPAC-2017-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party NanOlogy, LLC
Study Sponsor  ICMJE NanOlogy, LLC
Collaborators  ICMJE US Biotest, Inc.
Investigators  ICMJE Not Provided
PRS Account NanOlogy, LLC
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP