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Trial record 1 of 4 for:    nanopac
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Intracystic Injection of NanoPac® in Subjects With Mucinous Cystic Pancreatic Neoplasms

This study is currently recruiting participants.
Verified October 2017 by NanOlogy, LLC
Sponsor:
ClinicalTrials.gov Identifier:
NCT03188991
First Posted: June 16, 2017
Last Update Posted: October 23, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
US Biotest, Inc.
Information provided by (Responsible Party):
NanOlogy, LLC
  Purpose
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 Intervention Phase
Pancreatic Mucinous-Cystic Neoplasm Drug: NanoPac® Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Open-label, dose rising, Phase 2a trial with a dose escalation phase and a dose confirmation phase. 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. In the dose confirmation phase, 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 enroll additional subjects to provide a total of 12 subjects at that dose level.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2a Trial Evaluating the Safety of Intracystic Injection of NanoPac® in Subjects With Mucinous Cystic Pancreatic Neoplasms

Resource links provided by NLM:


Further study details as provided by NanOlogy, LLC:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 30
Anticipated Study Start Date: October 2017
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NanoPac® 6 mg/mL
Single intracystic injection of NanoPac® at a dose of 6 mg/mL in a volume equal to the amount of fluid removed from the cyst
Drug: NanoPac®
NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)
Experimental: NanoPac® 10 mg/mL
Single intracystic injection of NanoPac® at a dose of 10 mg/mL in a volume equal to the amount of fluid removed from the cyst
Drug: NanoPac®
NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)
Experimental: NanoPac® 15 mg/mL
Single intracystic injection of NanoPac® at a dose of 15 mg/mL in a volume equal to the amount of fluid removed from the cyst
Drug: NanoPac®
NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)

Detailed Description:

In this open-label, dose rising, Phase 2a trial with an expanded cohort at the dose of NanoPac® (Sterile Nanoparticulate Paclitaxel) determined to have the best tolerability and safety profile, subjects with mucinous cystic pancreatic neoplasms will receive intracystic NanoPac® via endoscopic ultrasound-guided fine needle injection (EUS-FNI). The study will include a dose escalation phase and a dose confirmation phase.

Subjects will be enrolled in sequential cohorts of NanoPac® at 6, 10, and 15 mg/mL at volumes equal to the amount of fluid aspirated from the cyst. 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 enroll additional subjects to provide a total of 12 subjects at that dose level.

Plasma samples will be taken on the day 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 NanoPac® injection for safety, and cyst response to therapy (as shown by imaging). Cyst fluid will also be extracted and analyzed for cyst fluid markers.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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; cyst fluid carcinoembryonic antigen (CEA) will be documented (CEA > 192 U/L); KRAS analysis may also be performed at the discretion of the Investigator;
  • Unilocular cyst with diameter of at least 2 cm but no more than 4 cm measurable by MRCP;
  • Normal hematologic, hepatic, and renal function;
  • 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
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


Contacts
Contact: Shelagh Verco, PhD 805-595-1300 NANOPAC201701@usbiotest.com
Contact: Gere diZerega, MD 805-595-1300 gere.dizerega@usbiotest.com

Locations
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Aziz Tabash    713-798-5765    Abdalaziz.Tabash@bcm.edu   
Principal Investigator: Mohamed Othman, MD         
Sponsors and Collaborators
NanOlogy, LLC
US Biotest, Inc.
Investigators
Principal Investigator: Jacques Van Dam, MD, PhD Keck School of Medicine, University of Southern California
  More Information

Responsible Party: NanOlogy, LLC
ClinicalTrials.gov Identifier: NCT03188991     History of Changes
Other Study ID Numbers: NANOPAC-2017-01
First Submitted: June 13, 2017
First Posted: June 16, 2017
Last Update Posted: October 23, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases