Trial of NanoPac Intratumoral Injection in Lung Cancer

Lung Cancer Clinical Trial

Official title:

Phase 2 Trial Evaluating the Safety and Tolerability of Intratumoral Injections of NanoPac® With Standard of Care Therapy in Subjects With Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04314895
• Other study ID #: NANOPAC-2020-01
• Status: Completed
• Phase: Phase 2
• Start date: April 14, 2021
• Est. completion date: September 26, 2023

Study information

• Verified date: November 2023
• Source: NanOlogy, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 26, 2023
• Est. primary completion date: September 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Cancer, Nonsmall Cell
• Lung Cancer, Small Cell
• Lung Neoplasms
• Neoplasm of Lung
• Small Cell Lung Carcinoma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins	Baltimore	Maryland
United States	University of North Carolina Chapel Hill	Chapel Hill	North Carolina
United States	Parkview Research Institute	Fort Wayne	Indiana
United States	University of Florida Health	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
NanOlogy, LLC	US Biotest, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment emergent adverse events		Day 1 to Week 24 (6 Months)
Secondary	Concentration of paclitaxel in the systemic circulation post-injection		Day 1, Weeks 1, 2, 4, 5, 6, 8, 9, 10, 12, 18, and 24
Secondary	Progression free survival	Progression free survival as assessed using RECIST v1.1	Day 1 and Weeks 24 and 52
Secondary	Overall survival	As determined by survival time following first NanoPac injection	Day 1 and Week 52
Secondary	Change in tumor dimensions	As determined by CT scan imaging	Day 1 and Weeks 12, 24, 38, and 52