Trial of NanoPac Intratumoral Injection in Lung Cancer

NCT04314895 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: NANOPAC-2020-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

Brief Summary

This study evaluates the use of NanoPac injected directly into tumors in the lung of people with lung cancer.

Conditions

Lung Cancer, Nonsmall Cell; Lung Cancer; Lung Cancer, Small Cell; Neoplasm of Lung

Keywords

paclitaxel

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events

  AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.

  Day 1 to Week 24 (6 Months)

Secondary Outcomes (4)

• Concentration of Paclitaxel in the Systemic Circulation Post-injection

  Day 1, Weeks 1, 2, 4, 5, 6, 8, 9, 10, 12, 18, and 24

• Progression Free Survival (PFS)

  Weeks 24, 38, and 52

• Overall Survival

  Weeks 24, 38, and 52

• Change in Tumor Dimensions (Longest Diameter)

  Weeks 12, 24, 38, and 52

Study Arms (1)

NanoPac

EXPERIMENTAL

Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart.

Drug: NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension

Interventions

NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension DRUG

NanoPac is manufactured using a Precipitation with Compressed Antisolvent (PCA) technique that employs supercritical carbon dioxide and acetone to generate paclitaxel nanoparticles within a well-characterized particle-size distribution. Following PCA, NanoPac is filled into a clear 60mL Type 1, USP, clear-glass vial (306 mg/vial) as a powder fill of nanoparticulate paclitaxel, closed with a bromobutyl rubber stopper and aluminum crimp seal, and sterilized by gamma irradiation. Prior to administration at the hospital/clinic, NanoPac will be reconstituted with 1% Polysorbate 80, NF in 0.9% Sodium Chloride for Injection, USP, to form a suspension. The suspension will be further diluted with 0.9% Sodium Chloride for Injection, USP to achieve the final clinical formulation.

Also known as: paclitaxel

NanoPac

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent;
• Age ≥18 years and able to tolerate the EBUS-TBNI procedure;
• Histologically/cytologically confirmed lung cancer. Eligible subjects may include, for example: primary or recurrent non-resectable disease, locally advanced stages II and III with nodal disease, stage IV advanced disease;
• At least one lesion documented via imaging (within 4 weeks of Screening) which can be accessed using EBUS-TBNI;
• Subject is not a candidate for surgery;
• Has received or plans to receive SOC chemotherapy; adequate hematologic recovery must be confirmed according to the institution's SOC;
• Performance Status (ECOG) 0-2 at study entry;
• Life expectancy of at least 6 months;
• Adequate marrow, liver, and renal function at study entry;
• ANC ≥ 1.5 x 109/L;
• Hemoglobin ≥ 9.0 grams/dL;
• Platelets ≥ 75 x 109/L;
• Total bilirubin ≤ 1.5x institutional ULN;
• AST/ ALT ≤ 2.5x institutional ULN;
• Creatinine ≤ 1.5x institutional ULN;

You may not qualify if:

• Significant cardiac disease (Class III or IV per New York Heart Association guidelines);
• Active bacterial, viral, or fungal infections (including active AIDS, hepatitis B or hepatitis C);
• Symptomatic central nervous system (CNS) metastasis which are neurologically unstable, or CNS disease requiring increase in steroid dose (treated metastatic disease and stable steroid use are not excluded)
• Known hypersensitivity to study agent;
• Pregnant or breastfeeding women.

Sponsors & Collaborators

• NanOlogy, LLC: lead
• US Biotest, Inc.: collaborator

Study Sites (4)

University of Florida Health

Gainesville, Florida, 32610, United States

Location

Parkview Research Institute

Fort Wayne, Indiana, 46845, United States

Location

Johns Hopkins

Baltimore, Maryland, 21205, United States

Location

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 27599-1350, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Small Cell Lung Carcinoma

Interventions

Powders; Suspensions; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Colloids; Complex Mixtures; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Mark Mitchell
• Organization: NanOlogy, LLC

mark.mitchell@dfb.com

8179004074

Study Officials

• Shelagh Verco, PhD

  US Biotest, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: March 19, 2020
• Study Start: April 14, 2021
• Primary Completion: September 26, 2023
• Study Completion: September 26, 2023
• Last Updated: May 23, 2025
• Results First Posted: May 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)