Pancreatic Mucinous-Cystic NeoplasmPhase 2NCT03188991

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

A Phase 2 study testing NanoPac® in people with Pancreatic Mucinous-Cystic Neoplasm, run by NanOlogy, LLC at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pancreatic Mucinous-Cystic Neoplasm
What is being tested?: NanoPac®
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 4 sitesUnited States
Study dates: 29 Sep 2017to 29 Jun 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

The Ohio State University, Wexner Medical Center
Columbus, Ohio, 43210
Texas Tech University Health Sciences Center
El Paso, Texas, 79905
Parkview Cancer Institute
Fort Wayne, Indiana, 46845
Baylor College of Medicine
Houston, Texas, 77030

Other trials in United States

About this study

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

Read the 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).

Conditions: Pancreatic Mucinous-Cystic Neoplasm
Being tested: NanoPac®
Keywords: pancreatic cystic neoplasm, pancreatic cyst, pancreatic mucinous cyst, pancreatic neoplasms, digestive system neoplasms, pancreatic diseases, mucinous cystic neoplasm
Medical subject headings: Pancreatic Cyst, Pancreatic Neoplasms, Digestive System Neoplasms, Pancreatic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03188991
Study group	Role	What they receive
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 Receives: 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 Receives: 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 Receives: 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. Receives: Drug: NanoPac®

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

Cyst Volume Response
Cyst volume at screening will be compared with the volume at Weeks 12 and 24 (or early termination).
Measured: Screening and 6 (six) months after first NanoPac® injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Sep 201729 Jun 2020

First posted16 Jun 2017
Study start29 Sep 2017
Primary completion29 Jun 2020
Study completion29 Jun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pancreatic Mucinous-Cystic NeoplasmStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
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)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03188991
Sponsor's protocol ID: NANOPAC-2017-01
Status last verified: Jun 2021
First submitted: 13 Jun 2017
Last updated: 14 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Trial Evaluating Escalating Doses and the Safety of Intracystic Injection of NanoPac® in Subjects With Mucinous Cystic Pancreatic Neoplasms
ClinicalTrials.gov ID: NCT03188991
Acronym / sponsor ID: NANOPAC-2017-01
Conditions: Pancreatic Mucinous-Cystic Neoplasm
Keywords: pancreatic cystic neoplasm, pancreatic cyst, pancreatic mucinous cyst, pancreatic neoplasms, digestive system neoplasms, pancreatic diseases, mucinous cystic neoplasm
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: NanOlogy, LLCIndustry (pharma, biotech, devices)
Collaborators: US Biotest, Inc.
Study start: 29 Sep 2017 (actual)
Primary completion: 29 Jun 2020 (actual)
Study completion: 29 Jun 2020 (actual)
First posted: 16 Jun 2017 (actual)
Results: Posted 8 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Subjects will be followed for 6 months after the first NanoPac® injection for safety, tolerability and cyst response to therapy (as shown by imaging).

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 4
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.

Arm	Type	Receives
Dose Escalation: NanoPac® 6 mg/mL	Experimental	Drug: NanoPac®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
Dose Escalation: NanoPac® 10 mg/mL	Experimental	Drug: NanoPac®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
Dose Escalation: NanoPac® 15 mg/mL	Experimental	Drug: NanoPac®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
Second Phase: NanoPac® at Best Dose	Experimental	Drug: NanoPac®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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NanoPac®NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)	Drug	Dose Escalation: NanoPac® 10 mg/mL, Dose Escalation: NanoPac® 15 mg/mL, Dose Escalation: NanoPac® 6 mg/mL, Second Phase: NanoPac® at Best Dose

Primary outcome

Number of Participants With 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.

1 secondary outcome

Cyst Volume Response
Time frame: Screening and 6 (six) months after first NanoPac® injection

Results and safety

Results posted to the registry on 8 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dose Escalation: NanoPac® 6 mg/mL	3	3
Dose Escalation: NanoPac® 10 mg/mL	3	3
Dose Escalation: NanoPac® 15 mg/mL	3	3
Second Phase: NanoPac® 15 mg/mL (Up to Two Injections)	11	10

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

Time frame: Up to 6 (six) months after first NanoPac® injection. Count of participants. Unit: Participants

Measure	Dose Escalation: NanoPac® 6 mg/mL n = 3	Dose Escalation: NanoPac® 10 mg/mL n = 3	Dose Escalation: NanoPac® 15 mg/mL n = 3	Second Phase: NanoPac® 15 mg/mL (Up to Two Injections) n = 10
Value	3	3	3	9

1 secondary outcome is reported in the full results.

Adverse events

Time frame: AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dose Escalation: NanoPac® 6 mg/mL	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
Dose Escalation: NanoPac® 10 mg/mL	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Dose Escalation: NanoPac® 15 mg/mL	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
Second Phase: NanoPac® 15 mg/mL (Up to Two Injections)	3 of 10 (30%)	9 of 10 (90%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NanoPac® in people with Pancreatic Mucinous-Cystic Neoplasm, run by NanOlogy, LLC at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability) (time frame: Up to 6 (six) months after first NanoPac® injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03188991.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.