Intracystic Injection Of NanoPac® In Subjects With Mucinous Cystic Pancreatic Neoplasms

Study Overview

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

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.

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).

Pancreatic Mucinous-Cystic Neoplasm

DRUG: NanoPac®

NANOPAC-2017-01

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2017-06-13	Results First Submitted 2021-05-12	Last Update Submitted that met QC Criteria 2021-06-07
First Submitted that Met QC Criteria 2017-06-15	Results First Submitted that Met QC Criteria 2021-05-12	Last Update Posted (ACTUAL) 2021-06-14
First Posted (ACTUAL) 2017-06-16	Results First Posted 2021-06-08	Last Verified 2021-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/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)

Primary Outcome Measures	Measure Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability)	Treatment Emergent Adverse Events will include laboratory assessments, physical examination findings, and vital signs.	Up to 6 (six) months after first NanoPac® injection

Secondary Outcome Measures	Measure Description	Time Frame
Cyst Volume Response	Cyst volume at screening will be compared with the volume at Weeks 12 and 24 (or early termination).	Screening and 6 (six) months after first NanoPac® injection

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

Positive cytology indicating malignancy;
Thrombotic or embolic events;
Known hypersensitivity to study agent;
Known drug or alcohol abuse;
Pregnant or breastfeeding women.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

US Biotest, Inc.

Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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