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

Study 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.

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Key things to know

Main goalSupportive Care

This describes the study’s primary purpose.

What is being studiedPaclitaxel

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

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

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?Mercator MedSystems, Inc.

Study sponsor

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

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How this study is categorized

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

Cancer type

Non-small cell lung cancer (NSCLC)→

Treatment approach

Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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

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

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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