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

NCT03188991 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: NANOPAC-2017-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

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.

Conditions

Pancreatic Mucinous-Cystic Neoplasm

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cyst Volume Response

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

Study Arms (4)

Dose Escalation: NanoPac® 6 mg/mL

EXPERIMENTAL

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®

Dose Escalation: NanoPac® 10 mg/mL

EXPERIMENTAL

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®

Dose Escalation: NanoPac® 15 mg/mL

EXPERIMENTAL

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®

Second Phase: NanoPac® at Best Dose

EXPERIMENTAL

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®

Interventions

NanoPac® DRUG

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

Dose Escalation: NanoPac® 10 mg/mL; Dose Escalation: NanoPac® 15 mg/mL; Dose Escalation: NanoPac® 6 mg/mL; Second Phase: NanoPac® at Best Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• NanOlogy, LLC: lead
• US Biotest, Inc.: collaborator

Study Sites (4)

Parkview Cancer Institute

Fort Wayne, Indiana, 46845, United States

Location

The Ohio State University, Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Texas Tech University Health Sciences Center

El Paso, Texas, 79905, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pancreatic Cyst; Pancreatic Neoplasms; Digestive System Neoplasms; Pancreatic Diseases

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Digestive System Diseases; Neoplasms by Site; Endocrine Gland Neoplasms; Endocrine System Diseases

Results Point of Contact

• Title: Gere S. diZerega, MD
• Organization: US Biotest, Inc.

gere.dizerega@usbiotest.com

805.595.1300

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 16, 2017
• Study Start: September 29, 2017
• Primary Completion: June 29, 2020
• Study Completion: June 29, 2020
• Last Updated: June 14, 2021
• Results First Posted: June 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)