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

Status: Completed
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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.

Locations
United States
Indiana
Parkview Cancer Institute
Fort Wayne
Ohio
The Ohio State University, Wexner Medical Center
Columbus
Texas
Texas Tech University Health Sciences Center
El Paso
Baylor College of Medicine
Houston
Time Frame
Start Date: September 29, 2017
Completion Date: June 29, 2020
Participants
Target number of participants: 20
Treatments
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
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
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
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.
Authors
Mohamed Othman, Neil Sharma, Irving Waxman, Jacques Van Dam, Antonio Mendoza-Ladd, Somashekar Krishna
Related Therapeutic Areas
Sponsors
Leads: NanOlogy, LLC
Collaborators: US Biotest, Inc.

This content was sourced from clinicaltrials.gov

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