NCT02784158

Brief 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 performance status, lack of geographic proximity), or because other medical interventions are not considered appropriate or acceptable.

Trial Health

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Trial Health Score

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Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 26, 2016

Completed
Last Updated

February 6, 2018

Status Verified

February 1, 2018

First QC Date

May 24, 2016

Last Update Submit

February 5, 2018

Conditions

Non-small Cell Lung CancerLung CancerAdvanced MalignanciesCarcinoma

Keywords

Non-small cell lung cancerNon-small cell lung carcinomaEpithelial lung cancerSquamous cell carcinomaLarge cell carcinomaAdenocarcinomaAnaplastic lymphoma kinase (ALK)CarcinomaAdvanced CancersBrigatinibAP26113

Interventions

BrigatinibDRUG

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.

Also known as: AP26113

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

UC San Diego Moores Cancer Center (Site 099)

La Jolla, California, 92093-0698, United States

Location

UCI Medical Center-Chao Family Comprehensive (Site 210)

Orange, California, 92868-3201, United States

Location

Karmanos Cancer Institute (Site 070)

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung NeoplasmsCarcinomaCarcinoma, Squamous CellCarcinoma, Large CellAdenocarcinoma

Interventions

brigatinib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2016

First Posted

May 26, 2016

Last Updated

February 6, 2018

Record last verified: 2018-02

Locations

US(3)