Trial of NanoPac Intratumoral Injection in Lung Cancer

Sponsor

NanOlogy, LLC (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04314895

Collaborator

US Biotest, Inc. (Industry)

Enrollment

Locations

Arm

25.6

Anticipated Duration (Months)

4.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer, Nonsmall Cell Lung Cancer Lung Cancer, Small Cell Neoplasm of Lung	Drug: NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 14, 2021

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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. Other Names: paclitaxel

Arm

Intervention/Treatment

Experimental: 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.

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.

Other Names:

paclitaxel

Outcome Measures

Primary Outcome Measures

Number of participants with treatment emergent adverse events [Day 1 to Week 24 (6 Months)]

Secondary Outcome Measures

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 [Day 1 and Weeks 24 and 52]
Progression free survival as assessed using RECIST v1.1
Overall survival [Day 1 and Week 52]
As determined by survival time following first NanoPac injection
Change in tumor dimensions [Day 1 and Weeks 12, 24, 38, and 52]
As determined by CT scan imaging

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 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:

Malignant Airway Obstruction;
Known hypersensitivity to study agent;
Pregnant or breastfeeding women.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida Health	Gainesville	Florida	United States	32610
2	Parkview Research Institute	Fort Wayne	Indiana	United States	46845
3	Johns Hopkins	Baltimore	Maryland	United States	21205
4	University of North Carolina Chapel Hill	Chapel Hill	North Carolina	United States	27599-1350