A Phase 2 interventional study of NanoPac® in Pancreatic Mucinous-Cystic Neoplasm, sponsored by NanOlogy, LLC. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-14.
Sponsored by NanOlogy, LLC · Phase 2, Interventional, and Treatment
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.
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).
9,359 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.
This study's enrollment of 20 is below the median of 50 across 7,250 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →NanOlogy, LLC is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.
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Appropriate steps taken to minimize or avoid the potential for pregnancy for subjects of child-bearing potential.*
Exclusion Criteria:
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®
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®
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®
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)
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.
Time frame: Up to 6 (six) months after first NanoPac® injection
Cyst Volume Response
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
| Milestone | Dose Escalation: NanoPac® 6 mg/mL | Dose Escalation: NanoPac® 10 mg/mL | Dose Escalation: NanoPac® 15 mg/mL | Second Phase: NanoPac® 15 mg/mL (Up to Two Injections) |
|---|---|---|---|---|
| Started | 3 | 3 | 3 | 11 |
| Completed | 3 | 3 | 3 | 10 |
| Not completed | 0 | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 1 |
Treatment Emergent Adverse Events will include laboratory assessments, physical examination findings, and vital signs.
| Participants | Dose Escalation: NanoPac® 6 mg/mL | Dose Escalation: NanoPac® 10 mg/mL | Dose Escalation: NanoPac® 15 mg/mL | Second Phase: NanoPac® 15 mg/mL (Up to Two Injections) |
|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability) | 3 | 3 | 3 | 9 |
Cyst volume at screening will be compared with the volume at Weeks 12 and 24 (or early termination).
| mL | Dose Escalation: NanoPac® 6 mg/mL | Dose Escalation: NanoPac® 10 mg/mL | Dose Escalation: NanoPac® 15 mg/mL | Second Phase: NanoPac® 15 mg/mL (Up to Two Injections) |
|---|---|---|---|---|
| Screening | 7.770 ± 3.283 | 4.810 ± 5.109 | 10.960 ± 8.484 | 11.442 ± 8.132 |
| Week 12 | 5.710 ± 3.892 | 3.453 ± 2.188 | 9.633 ± 9.284 | 12.293 ± 10.755 |
| Week 24/EOS | 4.140 ± 3.920 | 4.383 ± 0.521 | 8.533 ± 7.183 | 11.138 ± 11.931 |
Collected over AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dose Escalation: NanoPac® 6 mg/mL | 0/3 (0%) | 1/3 (33.3%) | 3/3 (100%) |
| Dose Escalation: NanoPac® 10 mg/mL | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Dose Escalation: NanoPac® 15 mg/mL | 0/3 (0%) | 1/3 (33.3%) | 3/3 (100%) |
| Second Phase: NanoPac® 15 mg/mL (Up to Two Injections) | 0/10 (0%) | 3/10 (30%) | 9/10 (90%) |
| Event | Dose Escalation: NanoPac® 6 mg/mL | Dose Escalation: NanoPac® 10 mg/mL | Dose Escalation: NanoPac® 15 mg/mL | Second Phase: NanoPac® 15 mg/mL (Up to Two Injections) |
|---|---|---|---|---|
| Breast CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/3 | 0/3 | 0/3 | 0/10 |
| Abdominal PainGastrointestinal disorders | 0/3 | 0/3 | 1/3 | 0/10 |
| Obstruction GastricGastrointestinal disorders | 0/3 | 0/3 | 0/3 | 1/10 |
| Hepatic encephalopathyNervous system disorders | 0/3 | 0/3 | 0/3 | 1/10 |
| Organising pneumoniaRespiratory, thoracic and mediastinal disorders | 0/3 | 0/3 | 0/3 | 1/10 |
| Event | Dose Escalation: NanoPac® 6 mg/mL | Dose Escalation: NanoPac® 10 mg/mL | Dose Escalation: NanoPac® 15 mg/mL | Second Phase: NanoPac® 15 mg/mL (Up to Two Injections) |
|---|---|---|---|---|
| Abdominal discomfortGastrointestinal disorders | 2/3 | 2/3 | 1/3 | 0/10 |
| Abdominal pain upperGastrointestinal disorders | 0/3 | 2/3 | 0/3 | 1/10 |
| DiarrhoeaGastrointestinal disorders | 1/3 | 2/3 | 0/3 | 1/10 |
| NauseaGastrointestinal disorders | 1/3 | 2/3 | 1/3 | 1/10 |
| FatigueGeneral disorders | 0/3 | 1/3 | 2/3 | 1/10 |
| Oedema peripheralGeneral disorders | 2/3 | 0/3 | 2/3 | 1/10 |
| ContusionInjury, poisoning and procedural complications | 0/3 | 0/3 | 2/3 | 0/10 |
| DizzinessNervous system disorders | 0/3 | 1/3 | 2/3 | 0/10 |
| HeadacheNervous system disorders | 0/3 | 2/3 | 0/3 | 1/10 |
| PruritusSkin and subcutaneous tissue disorders | 2/3 | 0/3 | 0/3 | 1/10 |
All enrolled subjects (n=20) who received at least one NanoPac injection (n=19) were designated as the Safety Population, and included in the analysis population for all outcome analyses. The subject who withdrew consent prior to any NanoPac treatment is not included in the analysis population.
| Age, Continuous(years) | Dose Escalation: NanoPac® 6 mg/mL | Dose Escalation: NanoPac® 10 mg/mL | Dose Escalation: NanoPac® 15 mg/mL | Second Phase: NanoPac® 15 mg/mL (Up to Two Injections) | Total |
|---|---|---|---|---|---|
| Mean | 66.3 ± 8.3 | 73.7 ± 11.5 | 59.7 ± 9.1 | 67.8 ± 6.6 | 67.2 ± 8.4 |
| Sex: Female, Male(Participants) | Dose Escalation: NanoPac® 6 mg/mL | Dose Escalation: NanoPac® 10 mg/mL | Dose Escalation: NanoPac® 15 mg/mL | Second Phase: NanoPac® 15 mg/mL (Up to Two Injections) | Total |
|---|---|---|---|---|---|
| Female | 3 | 2 | 2 | 6 | 13 |
| Male | 0 | 1 | 1 | 4 | 6 |
| Ethnicity (NIH/OMB)(Participants) | Dose Escalation: NanoPac® 6 mg/mL | Dose Escalation: NanoPac® 10 mg/mL | Dose Escalation: NanoPac® 15 mg/mL | Second Phase: NanoPac® 15 mg/mL (Up to Two Injections) | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 3 | 3 |
| Not Hispanic or Latino | 3 | 3 | 3 | 7 | 16 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Dose Escalation: NanoPac® 6 mg/mL | Dose Escalation: NanoPac® 10 mg/mL | Dose Escalation: NanoPac® 15 mg/mL | Second Phase: NanoPac® 15 mg/mL (Up to Two Injections) | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 0 | 0 | 1 | 3 |
| White | 1 | 3 | 3 | 8 | 15 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 1 | 1 |
| Body Mass Index (BMI) (kg/m2)(kg/m2) | Dose Escalation: NanoPac® 6 mg/mL | Dose Escalation: NanoPac® 10 mg/mL | Dose Escalation: NanoPac® 15 mg/mL | Second Phase: NanoPac® 15 mg/mL (Up to Two Injections) | Total |
|---|---|---|---|---|---|
| Mean | 34.83 ± 11.71 | 27.93 ± 10.20 | 26.67 ± 3.43 | 32.82 ± 7.17 | 31.39 ± 7.91 |
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NanOlogy, LLC