Malignant Airway Obstruction Secondary to Non-small Cell Lung CancerBROADWAYNCT02066103
Broncho-Adventitial Delivery of Paclitaxel to Extend Airway Patency in Malignant Airway Obstruction Patients
A study testing Paclitaxel in people with Malignant Airway Obstruction Secondary to Non-small Cell Lung Cancer, run by Mercator MedSystems, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Airway Obstruction Secondary to Non-small Cell Lung Cancer
- What is being tested?
- Paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins University
Baltimore, Maryland, 21287
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Duke University
Raleigh, North Carolina
About this study
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.
- Being tested
- Paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment safety
Adverse Events (AEs), Serious Adverse Events (SAEs), and all Unanticipated Adverse Device Effects (UADEs)
Measured: 12 weeks
Technical success
Device deployment and infusion success
Measured: procedure day
Secondary outcomes (2)
Airway patency improvements
Measured: 6 weeks
Quality of Life
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startJul 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Airway Obstruction Secondary to Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mercator MedSystems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066103
- Sponsor's protocol ID
- TSP0147
- Other IDs
- 5R42CA141907-03
- Acronym
- BROADWAY
- Status last verified
- Apr 2018
- First submitted
- 13 Feb 2014
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
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 Sep;156(3):562-570. doi: 10.1016/j.chest.2019.02.006. Epub 2019 Feb 15.
PubMed 30776363
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Broncho-Adventitial Delivery of Paclitaxel to Extend Airway Patency in Malignant Airway Obstruction Patients
- ClinicalTrials.gov ID
- NCT02066103
- Acronym / sponsor ID
- BROADWAY / TSP0147
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mercator MedSystems, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2014 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 19 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (17 listed)
- 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:
- Individuals with neurological, mental or psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paclitaxel | Drug | Treatment |
Primary outcome
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
2 secondary outcomes
Airway patency improvements
Time frame: 6 weeks
Quality of Life
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
- Derived from this study: PubMed 30776363Yarmus 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 Sep;156(3):562-570. doi: 10.1016/j.chest.2019.02.006. Epub 2019 Feb 15.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paclitaxel in people with Malignant Airway Obstruction Secondary to Non-small Cell Lung Cancer, run by Mercator MedSystems, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment safety (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02066103, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2018.