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

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ClinicalTrials.gov Identifier: NCT02066103
Recruitment Status : Completed
First Posted : February 19, 2014
Last Update Posted : April 20, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mercator MedSystems, Inc.

Tracking Information
First Submitted Date  ICMJE February 13, 2014
First Posted Date  ICMJE February 19, 2014
Last Update Posted Date April 20, 2018
Actual Study Start Date  ICMJE July 2014
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2014)
  • Treatment safety [ Time Frame: 12 weeks ]
    Adverse Events (AEs), Serious Adverse Events (SAEs), and all Unanticipated Adverse Device Effects (UADEs)
  • Technical success [ Time Frame: procedure day ]
    Device deployment and infusion success
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02066103 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2014)
  • Airway patency improvements [ Time Frame: 6 weeks ]
  • Quality of Life [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Broncho-Adventitial Delivery of Paclitaxel to Extend Airway Patency in Malignant Airway Obstruction Patients
Official Title  ICMJE Broncho-Adventitial Delivery of Paclitaxel to Extend Airway Patency in Malignant Airway Obstruction Patients
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Malignant Airway Obstruction Secondary to Non-small Cell Lung Cancer
Intervention  ICMJE Drug: Paclitaxel
Study Arms  ICMJE Experimental: Treatment
Intervention: Drug: Paclitaxel
Publications * Yarmus L, Mallow C, Akulian J, Lin CT, Ettinger D, Hales R, Voong KR, Lee H, Feller-Kopman D, Semaan R, Seward K, Wahidi MM. Prospective Multicentered Safety and Feasibility Pilot for Endobronchial Intratumoral Chemotherapy. Chest. 2019 Feb 15. pii: S0012-3692(19)30155-2. doi: 10.1016/j.chest.2019.02.006. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 14, 2014)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02066103
Other Study ID Numbers  ICMJE TSP0147
5R42CA141907-03 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mercator MedSystems, Inc.
Study Sponsor  ICMJE Mercator MedSystems, Inc.
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE Not Provided
PRS Account Mercator MedSystems, Inc.
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP