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Broncho-Adventitial Delivery of Paclitaxel to Extend Airway Patency in Malignant Airway Obstruction Patients | Clinical Trials | Clareo Health

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Broncho-Adventitial Delivery of Paclitaxel to Extend Airway Patency in Malignant Airway Obstruction Patients

NCT02066103•Mercator MedSystems, Inc.

View on ClinicalTrials.gov

Summary

Assess the safety and feasibility of local oncological drug delivery into the bronchial wall after recanalization of subjects with malignant airway obstruction. Safety and feasibility (technical success) will be assessed. This localized delivery is intended as an adjunct therapy and all subjects will receive standard of care oncology therapy as determined by their treating physicians.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Life expectancy of at least 12 weeks
•Adequate bone marrow, liver, and renal function
•Scheduled to undergo bronchoscopy for malignant airway obstruction as standard medical care
•Pathologically confirmed, unresectable primary or recurrent non-small cell lung cancer
•Measurable disease with obstruction into the airway
•Pathologically confirmed, unresectable primary or recurrent non-small cell lung cancer
•Patients undergo recanalization procedure of tumor during bronchoscopy
•Investigator is able to insert and deploy the Blowfish Catheter into the airway after recanalization

Exclusion Criteria

•Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer
•Pregnant or nursing female subjects, or female subjects of child bearing potential who refuse to take a pregnancy test prior to their enrollment in this study
•Uncontrolled infection
•Presence or recent history of any systemic disorder or conditions, such as:
•* uncontrolled hypertension
•* type 1 diabetes
•* severe pulmonary hypertension
•* acute kidney injury
•* stroke (within the last 6 month)
•* myocardial infarction (within the last 3 months)
+6 more criteria

Locations (3)

Johns Hopkins University

Baltimore, Maryland, United States

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Duke University

Raleigh, North Carolina, United States

Key Dates

Start Date

July 1, 2014

Primary Completion Date

June 1, 2016

Completion Date

June 1, 2016

Last Updated

April 20, 2018

Enrollment

ACTUAL participants

Conditions

Malignant Airway Obstruction Secondary to Non-small Cell Lung Cancer

Interventions

Paclitaxel

DRUG