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

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ClinicalTrials.gov Identifier: NCT02784158
Expanded Access Status : No longer available
First Posted : May 26, 2016
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda ( Ariad Pharmaceuticals )

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.

Condition or disease Intervention/treatment
Non-small Cell Lung Cancer Lung Cancer Advanced Malignancies Carcinoma Drug: Brigatinib

Study Type : Expanded Access



Intervention Details:
  • Drug: Brigatinib
    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.
    Other Name: AP26113

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion 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.

Exclusion 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02784158


Locations
United States, California
UC San Diego Moores Cancer Center (Site 099)
La Jolla, California, United States, 92093-0698
UCI Medical Center-Chao Family Comprehensive (Site 210)
Orange, California, United States, 92868-3201
United States, Michigan
Karmanos Cancer Institute (Site 070)
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Ariad Pharmaceuticals

Responsible Party: Ariad Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02784158     History of Changes
Other Study ID Numbers: AP26113-16-901
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018

Keywords provided by Takeda ( Ariad Pharmaceuticals ):
Brigatinib
AP26113
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

Additional relevant MeSH terms:
Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms