Trial of NanoPac Intratumoral Injection in Lung Cancer

NCT ID: NCT04314895

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-14
• Study Completion Date: 2023-09-26

Brief Summary

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

Detailed Description

NanoPac is very small (submicron) particles of the chemotherapy drug, paclitaxel, which is administered intravenously in a number of types of cancer. These submicron particles are injected directly into solid tumors to target cancer at the site of disease with less systemic exposure than intravenously administered chemotherapy. In this study, the submicron particle paclitaxel will be injected directly into tumors in the lungs of people with small cell or non-small cell lung cancer. All subjects in this study will receive NanoPac and will be evaluated to see if NanoPac is safe and has an effect on the tumor within the lung.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NanoPac

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.

Group Type: EXPERIMENTAL

NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension

Intervention Type: 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.

Interventions

NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension

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.

Intervention Type: DRUG

Other Intervention Names

paclitaxel

Eligibility Criteria

Inclusion Criteria

• 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;
• Appropriate steps taken to minimize or avoid the potential for pregnancy for subjects of child-bearing potential.*

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Biotest, Inc.

INDUSTRY

Sponsor Role: collaborator

NanOlogy, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shelagh Verco, PhD

Role: STUDY_DIRECTOR

US Biotest, Inc.

Locations

University of Florida Health

Gainesville, Florida, United States

Parkview Research Institute

Fort Wayne, Indiana, United States

Johns Hopkins

Baltimore, Maryland, United States

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

NANOPAC-2020-01

Identifier Type: -

Identifier Source: org_study_id