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Trial of NanoPac Intratumoral Injection in Lung Cancer

Primary Purpose

Lung Cancer, Nonsmall Cell, Lung Cancer, Lung Cancer, Small Cell

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension
Sponsored by
NanOlogy, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer, Nonsmall Cell focused on measuring paclitaxel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 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.

Sites / Locations

  • University of Florida Health
  • Parkview Research Institute
  • Johns Hopkins
  • University of North Carolina Chapel Hill

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NanoPac

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of participants with treatment emergent adverse events

Secondary Outcome Measures

Concentration of paclitaxel in the systemic circulation post-injection
Progression free survival
Progression free survival as assessed using RECIST v1.1
Overall survival
As determined by survival time following first NanoPac injection
Change in tumor dimensions
As determined by CT scan imaging

Full Information

First Posted
March 17, 2020
Last Updated
January 9, 2023
Sponsor
NanOlogy, LLC
Collaborators
US Biotest, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04314895
Brief Title
Trial of NanoPac Intratumoral Injection in Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 14, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NanOlogy, LLC
Collaborators
US Biotest, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Nonsmall Cell, Lung Cancer, Lung Cancer, Small Cell, Neoplasm of Lung
Keywords
paclitaxel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NanoPac
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension
Other Intervention Name(s)
paclitaxel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with treatment emergent adverse events
Time Frame
Day 1 to Week 24 (6 Months)
Secondary Outcome Measure Information:
Title
Concentration of paclitaxel in the systemic circulation post-injection
Time Frame
Day 1, Weeks 1, 2, 4, 5, 6, 8, 9, 10, 12, 18, and 24
Title
Progression free survival
Description
Progression free survival as assessed using RECIST v1.1
Time Frame
Day 1 and Weeks 24 and 52
Title
Overall survival
Description
As determined by survival time following first NanoPac injection
Time Frame
Day 1 and Week 52
Title
Change in tumor dimensions
Description
As determined by CT scan imaging
Time Frame
Day 1 and Weeks 12, 24, 38, and 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shelagh Verco, PhD
Organizational Affiliation
US Biotest, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Florida Health
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Parkview Research Institute
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
University of North Carolina Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-1350
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Trial of NanoPac Intratumoral Injection in Lung Cancer

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