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Trial record 21 of 2066 for:    Pancreatic Cancer AND Digestive System Neoplasms

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

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ClinicalTrials.gov Identifier: NCT03188991
Recruitment Status : Recruiting
First Posted : June 16, 2017
Last Update Posted : August 27, 2019
Sponsor:
Collaborator:
US Biotest, Inc.
Information provided by (Responsible Party):
NanOlogy, LLC

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). Cyst fluid will also be extracted and analyzed for cyst fluid markers.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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 :
  1. Incidence of 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. Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) of NanoPac® [ Time Frame: Up to 6 (six) months after first NanoPac® injection ]
  2. Pharmacokinetics: Peak plasma concentration (Cmax) of NanoPac® [ Time Frame: Up to 6 (six) months after NanoPac® injection ]
  3. Pharmacokinetics: Time at which peak plasma concentration is observed (Tmax) of NanoPac® [ Time Frame: Up to 6 (six) months after first NanoPac® injection ]
  4. 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).



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.

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

Locations
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United States, Indiana
Parkview Cancer Institute Recruiting
Fort Wayne, Indiana, United States, 46845
Contact: Christina Zelt    260-266-4153    christina.zelt@parkview.com   
Principal Investigator: Neil Sharma, MD         
United States, Ohio
Ohio State University, Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Casey McClurkin    614-688-9575    casey.mcclurkin@osumc.edu   
Contact: Brianna Conley    614-366-4495    brianna.conley@osumc.edu   
Principal Investigator: Somashekar Krishna, MBBS         
United States, Texas
Texas Tech University Health Sciences Center Recruiting
El Paso, Texas, United States, 79905
Contact: Nancy Casner    915-215-5170    nancy.casner@ttuhsc.edu   
Principal Investigator: Antonio Mendoza-Ladd, MD         
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Michael Mercado    713-798-0945    Michael.Mercado@bcm.edu   
Principal Investigator: Mohamed Othman, MD         
Sponsors and Collaborators
NanOlogy, LLC
US Biotest, Inc.

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Responsible Party: NanOlogy, LLC
ClinicalTrials.gov Identifier: NCT03188991     History of Changes
Other Study ID Numbers: NANOPAC-2017-01
First Posted: June 16, 2017    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: August 2019
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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Pancreatic Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases