Lung Cancer Clinical Trial

A Study of Brigatinib in Participants With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib

Summary

The primary purpose of this study is to determine the efficacy of brigatinib by confirmed objective response rate (ORR) by response evaluation criteria in solid tumors (Response Evaluation Criteria in Solid Tumors [RECIST]), in participants with ALK+ locally advanced or metastatic NSCLC whose disease has progressed on therapy with alectinib or ceritinib.

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Full Description

The drug being tested in this study is called brigatinib (AP26113). Brigatinib is being tested to treat people who have anaplastic lymphoma kinase-positive (ALK+), advanced non-small-cell lung cancer (NSCLC).

The study will enroll approximately 103 patients. Participants will be assigned to the treatment group:

• Brigatinib

All participants will be asked to take brigatinib 90 mg tablet in lead-in period for 7 days, followed by brigatinib 180 mg at the same time each day throughout the study. Participants with progressive disease had an option to receive an escalated dose of brigatinib 240 mg as per investigator's discretion in case no toxicities (greater than grade 2) are experienced.

This multicenter trial will be conducted worldwide. The overall time to participate in this study is approximately 3 years. Participants will make multiple visits to the clinic, and 30 days after last dose of study drug for a follow-up assessment.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Have histologically or cytologically confirmed stage IIIB (locally advanced or recurrent and not a participant for curative therapy) or stage IV non-small-cell lung cancer (NSCLC).

Must meet both of the following 2 criteria:

Have documentation of anaplastic lymphoma kinase (ALK) rearrangement by a positive result from any laboratory test® approved by the food and drug administration (FDA) or Have documented ALK rearrangement by a different test (non-FDA-approved local lab tests) and have provided tumor sample to the central laboratory. (Note: Central laboratory ALK rearrangement testing results are not required to be obtained before randomization.)
Had been on any one of the ALK tyrosine kinase inhibitor (TKIs) (alectinib, ceritinib, crizotinib) for at least 12 weeks before progression.
Had progressive disease (PD) while on alectinib or ceritinib
Had alectinib or ceritinib as the most recent ALK inhibitor therapy.
Have at least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) version 1.1 as assessed by the investigator.
Had recovered from toxicities related to prior anticancer therapy to national cancer institute common terminology criteria for adverse events (NCI CTCAE), version 4.03, Grade <=1. (Note: Treatment-related alopecia or peripheral neuropathy that are Grade >1 are allowed if deemed irreversible.) and have adequate major organ functions.
Have a life expectancy of ≥3 months.

Exclusion Criteria:

Had received any prior ALK-targeted TKI other than crizotinib, alectinib, or ceritinib.
Had received both alectinib and ceritinib.
Had previously received more than 3 regimens of systemic anticancer therapy for locally advanced or metastatic disease.
Had symptomatic brain metastasis (parenchymal or leptomeningeal). Participants with asymptomatic brain metastasis or who have stable symptoms that did not require an increased dose of corticosteroids to control symptoms in the past 7 days before the first dose of brigatinib may be enrolled.
Had current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Participants with leptomeningeal disease and without cord compression are allowed.
Had a cerebrovascular accident or transient ischemic attack within 6 months before first dose of brigatinib.
Had an ongoing or active infection, including, but not limited to, the requirement for intravenous antibiotics.
Had malabsorption syndrome or other gastrointestinal (GI) illness that could affect oral absorption of brigatinib.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

103

Study ID:

NCT03535740

Recruitment Status:

Active, not recruiting

Sponsor:

Ariad Pharmaceuticals

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There are 76 Locations for this study

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University of California Irvine Health Chao Family Comprehensive Cancer Center
Orange California, 92868, United States
The Oncology Institute of Hope and Innovation
Whittier California, 90602, United States
USOR - Rocky Mountain Cancer Centers - Pueblo
Pueblo Colorado, 81008, United States
Florida Hospital Medical Group
Orlando Florida, 32804, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Levine Cancer Institute - Southpark
Charlotte North Carolina, 28211, United States
Providence Portland Medical Center
Portland Oregon, 97213, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
USOR - Virginia Cancer Specialists - Fairfax Office
Fairfax Virginia, 22031, United States
Saint Vincent's Hospital Melbourne
Fitzroy Victoria, 3065, Australia
Peninsula & South Eastern Haematology and Oncology Group
Frankston Victoria, 3199, Australia
Sir Charles Gairdner Hospital
Nedlands Western Australia, 6009, Australia
Klinikum Klagenfurt Am Worthersee
Klagenfurt Carinthia, 9020, Austria
Krankenhaus Elisabethinen Linz
Linz Upper Austria, 4020, Austria
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
Tom Baker Cancer Center
Calgary British Columbia, T2N 2, Canada
Toronto University Health Network
Toronto Ontario, M5G 2, Canada
McGill University Health Centre
Montreal Quebec, H4A 3, Canada
Beijing Cancer Hospital
Beijing Beijing, 10000, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou Guangdong, 51000, China
Jilin Provincial Cancer Hospital (Changchun Cancer Hospital)
Changchun Jilin, 13000, China
Shanghai Pulmonary Hospital
Shanghai Shanghai, 20000, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou Zhejiang, 31000, China
Zhejiang Cancer Hospital
Hangzhou Zhejiang, 31000, China
Hopital Haut-Leveque
Pessac Aquitaine, 33604, France
Centre Hospitalier Intercommunal de Creteil
Creteil Ile-de-france, 94010, France
Hopital Larrey, CHU de Toulouse, Service de Pneumologie
Toulouse Cedex 9 Midi-pyrenees, 31059, France
Assistance Publique-Hopitaux de Marseille Hopital Nord
Marseille Provence Alpes COTE D'azur, 13915, France
Centre de Lutte Contre le Cancer Centre Leon Berard
Lyon Rhone-alpes, 69008, France
Thoraxklinik Heidelberg gGmbH
Heidelberg Baden-wuerttemberg, 69126, Germany
Universitatsklinikum Ulm
Ulm Baden-wuerttemberg, 89081, Germany
Klinikum Kempten-Oberallgau
Kempten Bavaria, 87439, Germany
Ludwig-Maximilians-Universitat Munchen
Munchen Bayern, 80336, Germany
Pius Hospital Oldenburg
Oldenburg Niedersachsen, 26121, Germany
Evangelisches Krankenhaus Hamm
Hamm Nordrhein-westfalen, 59063, Germany
HELIOS Klinikum Emil von Behring
Berlin , 14165, Germany
Prince of Wales Hospital
Shatin New Territories, , Hong Kong
Queen Mary Hospital
Hong Kong , 00852, Hong Kong
Queen Mary Hospital
Hong Kong , , Hong Kong
Queen Elizabeth Hospital
Kowloon , 1076, Hong Kong
Princess Margaret Hospital - Hong Kong
Kowloon , , Hong Kong
Azienda Ospedaliera San Camillo Forlanini
Roma Lazio, 00152, Italy
Centro di Riferimento Oncologico di Aviano
Aviano Pordenone, 33081, Italy
Azienda Ospedaliero - Universitaria San Luigi Gonzaga
Orbassano Torino, 10043, Italy
Istituto Europeo di Oncologia
Milano , 20141, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Napoli , 80131, Italy
Azienda Ospedaliero Universitaria di Parma
Parma , 43126, Italy
Azienda USL della Romagna
Ravenna , 48121, Italy
Fujita Health University Hospital
Toyoake Aichi, 470-1, Japan
Kanagawa Cancer Center
Yokohama Kanagawa, 241-8, Japan
Sendai Kousei Hospital
Sendai Miyagi, 980-0, Japan
Okayama University Hospital
Okayama-city Okayama, 700-8, Japan
Kansai Medical University Hirakata Hospital
Hirakata-shi Osaka, 573-1, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku Tokyo, 135-8, Japan
National Cancer Center
Goyang-si Gyeonggi-do, 411-7, Korea, Republic of
Gachon University Gil Medical Center
Incheon Gyeonggi-do, 21565, Korea, Republic of
Korea University Anam Hospital
Seoul Gyeonggi-do, 02841, Korea, Republic of
Chungbuk National University Hospital
Cheongju-si Gyeongsangbuk-do, 28644, Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu , 41931, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 135-7, Korea, Republic of
Maastricht University Medical Centre
Maastricht Limburg, 6229 , Netherlands
Vrije Universiteit Medisch Centrum
Amsterdam Noord-holland, 1081 , Netherlands
Erasmus University Medical Center
Rotterdam Zuid-holland, 3015 , Netherlands
Institut Catala d'Oncologia Badalona - Hospital Germans Trias i Pujol
Badalona Barcelona, 08916, Spain
Complejo Hospitalario Universitario A Coruna
A Coruna LA Coruna, 15006, Spain
Hospital Universitario Vall d'Hebron
Barcelona , 08035, Spain
Hospital Universitario Ramon Y Cajal
Madrid , 28034, Spain
Hospital Universitario La Paz
Madrid , 28046, Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Madrid , 28222, Spain
Skanes Universitetssjukhus i Lund
Lund Skane, 214 0, Sweden
Karolinska Universitetssjukhuset
Stockholm , 171 7, Sweden
Uppsala Akademiska Sjukhus
Uppsala , 751 8, Sweden
Changhua Christian Hospital
Changhua City Changhwa, 500, Taiwan
National Cheng Kung University
Tainan Tainan CITY, 70403, Taiwan
China Medical University Hospital
Taichung , 404, Taiwan
Taichung Veterans General Hospital
Taichung , 40705, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

103

Study ID:

NCT03535740

Recruitment Status:

Active, not recruiting

Sponsor:


Ariad Pharmaceuticals

How clear is this clinincal trial information?

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