CompletedNot applicableNCT02066103

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

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.

Checked against the public recordLast updated Apr 20, 2018 · Source: ClinicalTrials.gov

StatusCompleted
PhaseNot applicable
U.S. locations3
SponsorMercator MedSystems, Inc.
01
Study overview

What this study is about

Purpose
Supportive Care
Study type
Interventional
Phase
Not applicable
Sponsor
Mercator MedSystems, Inc.
Interventions being studied
Drug: Paclitaxel
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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) * Individuals with neurological, mental or psychiatric disorders * Concurrent participation in another study involving investigational drugs or investigational medical devices * Other (non-cancer) disease not stabilized within 1 month before the Screening Visit * Known hypersensitivity to paclitaxel, Cremophor EL, or iodinated contrast media * Any serious, uncontrolled comorbidity or condition that an Investigator believes would interfere with the intent of the study or would make participation not in the best interest of the patient Intraoperative Exclusion Criteria * Use of pulmonary airway stents and/or ongoing or initiation of local external beam or brachytherapy radiation * Any intraoperative complications that per the investigator's judgment increase the risk to the patient.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Johns Hopkins UniversityBaltimore, Maryland
  • The University of North Carolina at Chapel HillChapel Hill, North Carolina
  • Duke UniversityRaleigh, North Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 20, 2018. Always confirm current availability with the study team.

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