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

Primary Purpose

Pancreatic Mucinous-Cystic Neoplasm

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

NanoPac®

About this trial

This is an interventional treatment trial for Pancreatic Mucinous-Cystic Neoplasm focused on measuring pancreatic cystic neoplasm, pancreatic cyst, pancreatic mucinous cyst, pancreatic neoplasms, digestive system neoplasms, pancreatic diseases, mucinous cystic neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Parkview Cancer Institute
The Ohio State University, Wexner Medical Center
Texas Tech University Health Sciences Center
Baylor College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Dose Escalation: NanoPac® 6 mg/mL

Dose Escalation: NanoPac® 10 mg/mL

Dose Escalation: NanoPac® 15 mg/mL

Second Phase: NanoPac® at Best Dose

Arm Description

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

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

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Cyst Volume Response

Cyst volume at screening will be compared with the volume at Weeks 12 and 24 (or early termination).

Full Information

NCT ID

NCT03188991

First Posted

June 13, 2017

Last Updated

June 7, 2021

Sponsor

NanOlogy, LLC

Collaborators

US Biotest, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03188991

Brief Title

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

Official Title

A Trial Evaluating Escalating Doses and the Safety of Intracystic Injection of NanoPac® in Subjects With Mucinous Cystic Pancreatic Neoplasms

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

September 29, 2017 (Actual)

Primary Completion Date

June 29, 2020 (Actual)

Study Completion Date

June 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NanOlogy, LLC

Collaborators

US Biotest, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Mucinous-Cystic Neoplasm

Keywords

pancreatic cystic neoplasm, pancreatic cyst, pancreatic mucinous cyst, pancreatic neoplasms, digestive system neoplasms, pancreatic diseases, mucinous cystic neoplasm

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Sequential Assignment

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)

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dose Escalation: NanoPac® 6 mg/mL

Arm Type

Experimental

Arm Description

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

Arm Title

Dose Escalation: NanoPac® 10 mg/mL

Arm Type

Experimental

Arm Description

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

Arm Title

Dose Escalation: NanoPac® 15 mg/mL

Arm Type

Experimental

Arm Description

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

Arm Title

Second Phase: NanoPac® at Best Dose

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

NanoPac®

Intervention Description

NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)

Primary Outcome Measure Information:

Title

Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability)

Description

Treatment Emergent Adverse Events will include laboratory assessments, physical examination findings, and vital signs.

Time Frame

Up to 6 (six) months after first NanoPac® injection

Secondary Outcome Measure Information:

Title

Cyst Volume Response

Description

Cyst volume at screening will be compared with the volume at Weeks 12 and 24 (or early termination).

Time Frame

Screening and 6 (six) months after first NanoPac® injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Parkview Cancer Institute

City

Fort Wayne

State/Province

Indiana

ZIP/Postal Code

46845

Country

United States

Facility Name

The Ohio State University, Wexner Medical Center

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Texas Tech University Health Sciences Center

City

El Paso

State/Province

Texas

ZIP/Postal Code

79905

Country

United States

Facility Name

Baylor College of Medicine

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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