No Longer AvailableNot applicableNCT02784158
Official study title

An Expanded Access Study of Brigatinib for Patients With ALK-positive Advanced Non-Small Cell Lung Cancer

Study 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.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedBrigatinib

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · ALK · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 6, 2018 · Source: ClinicalTrials.gov

Is enrollment open?No Longer Available

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Expanded Access

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?Ariad Pharmaceuticals

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Expanded Access
Phase
Not applicable
Sponsor
Ariad Pharmaceuticals
Interventions being studied
Drug: Brigatinib
02
Explore related studies

How this study is categorized

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

03
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

1. Have histologically or cytologically confirmed locally advanced or metastatic NSCLC that is determined to have an ALK-rearrangement detected according to local standard procedure. 2. Resistant to or intolerant of at least 1 prior ALK TKI. 3. Recovered from toxicities related to prior anticancer therapy to NCI CTCAE, v4.0) grade ≤2. 4. Are a male or female patient ≥18 years old. 5. Have adequate organ and hematologic function, as defined by the study protocol. 6. Have Eastern Cooperative Oncology Group (ECOG) performance status ≤2. 7. 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. 8. For female patients of childbearing potential, a negative pregnancy test must be documented prior to enrollment (\<7 days prior to the first dose). 9. Female and male patients who are fertile must agree to use a highly effective form of contraception as defined by the study protocol. 10. 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.

Reasons someone may not be able to joinExclusion criteria

1. Received an ALK TKI within 10 days prior to the first dose of brigatinib. 2. Received cytotoxic chemotherapy, investigational agents, or radiation within 14 days, except stereotactic radiosurgery (SRS) or stereotactic body radiosurgery. 3. Received prior brigatinib therapy. 4. Received monoclonal antibodies within 30 days of the first dose of brigatinib. 5. Had major surgery within 30 days of the first dose of brigatinib. 6. Have current spinal cord compression. 7. Have significant, uncontrolled, or active cardiovascular disease within 6 months prior to first dose, as defined by the study protocol. 8. Have a history or the presence of pulmonary interstitial disease, drug-related pneumonitis, or radiation pneumonitis. 9. Have a known or suspected hypersensitivity to brigatinib or its excipients. 10. Have any condition or illness that, in the opinion of the investigator, would compromise patient safety. 11. Are pregnant or breastfeeding. 12. Are eligible for and have reasonable access to participate in another ongoing brigatinib clinical study.

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

04
Study sites

U.S. locations

  • UC San Diego Moores Cancer Center (Site 099)La Jolla, California
  • UCI Medical Center-Chao Family Comprehensive (Site 210)Orange, California
  • Karmanos Cancer Institute (Site 070)Detroit, Michigan

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 6, 2018. Always confirm current availability with the study team.

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