Clinical trial

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

NCT04314895

Name

NANOPAC-2020-01

Description

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

Trial arms

Trial start

2021-04-14

Estimated PCD

2023-09-26

Trial end

2023-09-26

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

NanoPac

Other names:

paclitaxel

Size

Primary endpoint

Number of participants with treatment emergent adverse events

Day 1 to Week 24 (6 Months)

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 18, 'type': 'ACTUAL'}}

Updated at

2023-11-13

1 organization

1 product

4 indications

Organization

Product

Indication

Indication

Indication

Indication