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

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. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pancreatic Mucinous-Cystic Neoplasm Drug: NanoPac® Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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
Official Title: A Trial Evaluating Escalating Doses and the Safety of Intracystic Injection of NanoPac® in Subjects With Mucinous Cystic Pancreatic Neoplasms
Actual Study Start Date : September 29, 2017
Actual Primary Completion Date : June 29, 2020
Actual Study Completion Date : June 29, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
 Drug: NanoPac®
NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)
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
 Drug: NanoPac®
NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)
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
 Drug: NanoPac®
NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)
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.
 Drug: NanoPac®
NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).


Eligibility Criteria
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Information from the National Library of Medicine

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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:

  • 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.
Contacts and Locations
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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): NCT03188991


Locations
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United States, Indiana
Parkview Cancer Institute
Fort Wayne, Indiana, United States, 46845
United States, Ohio
The Ohio State University, Wexner Medical Center
Columbus, Ohio, United States, 43210
United States, Texas
Texas Tech University Health Sciences Center
El Paso, Texas, United States, 79905
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
NanOlogy, LLC
US Biotest, Inc.
  Study Documents (Full-Text)

Documents provided by NanOlogy, LLC:
Study Protocol  [PDF] September 3, 2019
Statistical Analysis Plan  [PDF] August 21, 2020

More Information
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Responsible Party: NanOlogy, LLC
ClinicalTrials.gov Identifier: NCT03188991    
Other Study ID Numbers: NANOPAC-2017-01
First Posted: June 16, 2017    Key Record Dates
Results First Posted: June 8, 2021
Last Update Posted: June 14, 2021
Last Verified: June 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
Keywords provided by NanOlogy, LLC:
pancreatic cystic neoplasm
pancreatic cyst
pancreatic mucinous cyst
pancreatic neoplasms
 digestive system neoplasms
pancreatic diseases
mucinous cystic neoplasm
Additional relevant MeSH terms:
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Neoplasms
Pancreatic Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
 Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type