Non-small Cell Lung CancerNCT02784158
An Expanded Access Study of Brigatinib for Patients With ALK-positive Advanced Non-Small Cell Lung Cancer
A study testing Brigatinib in people with Non-small Cell Lung Cancer and Lung Cancer, run by Ariad Pharmaceuticals at 3 sites in United States.
Trial summary
The purpose of this study is to provide brigatinib for those patients with locally advanced and/or metastatic patients with ALK+ NSCLC on an expanded access basis due to their inability to meet eligibility criteria for on-going recruiting trials, inability to participate in other clinical trials (e.g., poor… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Lung Cancer, Advanced Malignancies
- What is being tested?
- Brigatinib
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 3 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Adult, Older adult
Who may be able to join
- Have histologically or cytologically confirmed locally advanced or metastatic NSCLC that is determined to have an ALK-rearrangement detected according to local standard procedure.
- Resistant to or intolerant of at least 1 prior ALK TKI.
- Recovered from toxicities related to prior anticancer therapy to NCI CTCAE, v4.0) grade ≤2.
- Are a male or female patient ≥18 years old.
- Have adequate organ and hematologic function, as defined by the study protocol.
- Have Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
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- Have normal QT interval on screening electrocardiogram (ECG) evaluation, defined as QT interval corrected (Fridericia) (QTcF) of ≤450 ms in males or ≤470 ms in females.
- For female patients of childbearing potential, a negative pregnancy test must be documented prior to enrollment (<7 days prior to the first dose).
- Female and male patients who are fertile must agree to use a highly effective form of contraception as defined by the study protocol.
- Must provide a signed and dated informed consent indicating that the patient has been informed of all pertinent aspects of the study, including the potential risks, and is willingly participating.
Who cannot join
- Received an ALK TKI within 10 days prior to the first dose of brigatinib.
- Received cytotoxic chemotherapy, investigational agents, or radiation within 14 days, except stereotactic radiosurgery (SRS) or stereotactic body radiosurgery.
- Received prior brigatinib therapy.
- Received monoclonal antibodies within 30 days of the first dose of brigatinib.
- Had major surgery within 30 days of the first dose of brigatinib.
- Have current spinal cord compression.
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- Have significant, uncontrolled, or active cardiovascular disease within 6 months prior to first dose, as defined by the study protocol.
- Have a history or the presence of pulmonary interstitial disease, drug-related pneumonitis, or radiation pneumonitis.
- Have a known or suspected hypersensitivity to brigatinib or its excipients.
- Have any condition or illness that, in the opinion of the investigator, would compromise patient safety.
- Are pregnant or breastfeeding.
- Are eligible for and have reasonable access to participate in another ongoing brigatinib clinical study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Karmanos Cancer Institute (Site 070)
Detroit, Michigan, 48201
UC San Diego Moores Cancer Center (Site 099)
La Jolla, California, 92093-0698
UCI Medical Center-Chao Family Comprehensive (Site 210)
Orange, California, 92868-3201
About this study
The purpose of this study is to provide brigatinib for those patients with locally advanced and/or metastatic patients with ALK+ NSCLC on an expanded access basis due to their inability to meet eligibility criteria for on-going recruiting trials, inability to participate in other clinical trials (e.g., poor performance status, lack of geographic proximity), or because other medical interventions are not considered appropriate or acceptable.
- Being tested
- Brigatinib
- Keywords
- Non-small cell lung cancer, Non-small cell lung carcinoma, Epithelial lung cancer, Squamous cell carcinoma, Large cell carcinoma, Adenocarcinoma, Anaplastic lymphoma kinase (ALK), Carcinoma, Advanced Cancers, Brigatinib, AP26113
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Carcinoma, Carcinoma, Squamous Cell, Carcinoma, Large Cell, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrigatinibDrug
Also called AP26113
Brigatinib will be administered orally to eligible patients with locally advanced or metastatic ALK+ NSCLC who are resistant or intolerant to a prior ALK inhibitor at a dose of 180 mg QD with a 7 day lead-in at 90 mg QD, continuously, with or without food.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Ariad Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784158
- Sponsor's protocol ID
- AP26113-16-901
- Status last verified
- Feb 2018
- First submitted
- 24 May 2016
- Last updated
- 6 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Expanded Access Study of Brigatinib for Patients With ALK-positive Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02784158
- Acronym / sponsor ID
- AP26113-16-901
- Keywords
- Non-small cell lung cancer, Non-small cell lung carcinoma, Epithelial lung cancer, Squamous cell carcinoma, Large cell carcinoma, Adenocarcinoma, Anaplastic lymphoma kinase (ALK), Carcinoma
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Ariad PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 26 May 2016 (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.
The purpose of this study is to provide brigatinib for those patients with locally advanced and/or metastatic patients with ALK+ NSCLC on an expanded access basis due to their inability to meet eligibility criteria for on-going recruiting trials, inability to participate in other clinical trials (e.g., poor performance status, lack of geographic proximity), or because other medical interventions are not considered appropriate or acceptable.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Have histologically or cytologically confirmed locally advanced or metastatic NSCLC that is determined to have an ALK-rearrangement detected according to local standard procedure.
- Resistant to or intolerant of at least 1 prior ALK TKI.
- Recovered from toxicities related to prior anticancer therapy to NCI CTCAE, v4.0) grade ≤2.
- Are a male or female patient ≥18 years old.
- Have adequate organ and hematologic function, as defined by the study protocol.
Key exclusion criteria (12 listed)
- Received an ALK TKI within 10 days prior to the first dose of brigatinib.
- Received cytotoxic chemotherapy, investigational agents, or radiation within 14 days, except stereotactic radiosurgery (SRS) or stereotactic body radiosurgery.
- Received prior brigatinib therapy.
- Received monoclonal antibodies within 30 days of the first dose of brigatinib.
- Had major surgery within 30 days of the first dose of brigatinib.
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 |
|---|---|---|
| BrigatinibAlso: AP26113Brigatinib will be administered orally to eligible patients with locally advanced or metastatic ALK+ NSCLC who are resistant or intolerant to a prior ALK inhibitor at a dose of 180 mg QD with a 7 day lead-in at 90 mg QD, continuously, with or without food. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
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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 Brigatinib in people with Non-small Cell Lung Cancer and Lung Cancer, run by Ariad Pharmaceuticals 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 10 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 6 Feb 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?
Results are not available in the source record.
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.
Where can I read the original study information?
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 6 Feb 2018; AzTrials last refreshed its copy on 6 Nov 2026.