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Trial of NanoPac Intratumoral Injection in Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04314895
Recruitment Status : Active, not recruiting
First Posted : March 19, 2020
Last Update Posted : January 10, 2023
Sponsor:
Collaborator:
US Biotest, Inc.
Information provided by (Responsible Party):
NanOlogy, LLC

Study Description
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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

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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
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Study Type : Interventional  (Clinical Trial)
Actual 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 : April 14, 2021
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Paclitaxel

Arms and Interventions
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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 Name: paclitaxel


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with treatment emergent adverse events [ Time Frame: Day 1 to Week 24 (6 Months) ]

Secondary Outcome Measures :
  1. 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 ]
  2. Progression free survival [ Time Frame: Day 1 and Weeks 24 and 52 ]
    Progression free survival as assessed using RECIST v1.1

  3. Overall survival [ Time Frame: Day 1 and Week 52 ]
    As determined by survival time following first NanoPac injection

  4. Change in tumor dimensions [ Time Frame: Day 1 and Weeks 12, 24, 38, and 52 ]
    As determined by CT scan imaging


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04314895


Locations
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United States, Florida
University of Florida Health
Gainesville, Florida, United States, 32610
United States, Indiana
Parkview Research Institute
Fort Wayne, Indiana, United States, 46845
United States, Maryland
Johns Hopkins
Baltimore, Maryland, United States, 21205
United States, North Carolina
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 27599-1350
Sponsors and Collaborators
NanOlogy, LLC
US Biotest, Inc.
Investigators
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Study Director: Shelagh Verco, PhD US Biotest, Inc.
More Information
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Responsible Party: NanOlogy, LLC
ClinicalTrials.gov Identifier: NCT04314895    
Other Study ID Numbers: NANOPAC-2020-01
First Posted: March 19, 2020    Key Record Dates
Last Update Posted: January 10, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NanOlogy, LLC:
paclitaxel
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
 Bronchial Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action