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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000635-27 | EudraCT Number | ||
| NL66462.078.18 | Registry Identifier | CCMO | |
| JapicCTI-194915 | Registry Identifier | JapicCTI |
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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brigatinib 90 mg/180 mg With Optional Dose Escalation to 240 mg | Experimental | Brigatinib 90 mg, tablets, orally, once daily (QD) for 7 days, followed by brigatinib 180 mg, tablets, orally, QD for until objective disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as assessed by the investigator, or intolerable toxicity. Participants who experienced progression on the 180 mg dose and had not experienced toxicities greater than Grade 2 had the option to receive brigatinib 240 mg QD based on investigator's discretion, up to 20 months until data cut-off: 30 September 2020. Participants who experienced progression on any doses but judged as still benefiting from the study treatment by the investigator may continue to use the current dose, up to study end. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brigatinib | Drug | Brigatinib Tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed Objective Response Rate (ORR) Using RECIST v1.1 as Assessed by the Independent Review Committee (IRC) | Confirmed ORR is defined as the percentage of the participants who are confirmed to have achieved complete response (CR) or partial response (PR), per RECIST version 1.1 (confirmed ≥4 weeks after initial response), after the initiation of study treatment. CR: disappearance of all extranodal target lesions and all pathological lymph nodes must have decreased to <10 mm in short axis and PR: at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions taking as reference the Baseline sum diameters. Percentages were rounded off to the nearest single decimal place. | Up to approximately 20 months from the start of enrollment till data cut-off 30 September 2020 |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed ORR Using RECIST v1.1 as Assessed by the Investigator | Confirmed ORR is defined as the percentage of the participants who are confirmed to have achieved CR or PR, per RECIST version 1.1 (confirmed ≥4 weeks after initial response), after the initiation of study treatment. CR: disappearance of all extranodal target lesions and all pathological lymph nodes must have decreased to <10 mm in short axis and PR: at least a 30% decrease in the SLD of target lesions taking as reference the baseline sum diameters. Percentages were rounded off to the nearest single decimal place. |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Irvine Health Chao Family Comprehensive Cancer Center | Orange | California | 92868 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41110382 | Derived | Mok T, Nishio M, Yoshida T, Ahn MJ, Kudou K, Asato T, Yang H, Tong X, Vincent S, Zhang P, Yamamoto N, Kim ES. Efficacy and safety of brigatinib after alectinib in patients with ALK-positive NSCLC: Integrated analysis of the ALTA-2 and J-ALTA studies. Lung Cancer. 2025 Nov;209:108793. doi: 10.1016/j.lungcan.2025.108793. Epub 2025 Oct 9. | |
| 36096442 |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Participants with diagnosis of ALK+, advanced NSCLC were enrolled to receive brigatinib 90 milligrams(mg) followed by 180 mg up to disease progression. 102 participants discontinued study up to interim data cut-off date: 20 May 2021. By 20 May 2021, all primary&secondary study outcome measure were met&data collection was complete. 1 participant stayed on until study completion as means to provide access to brigatinib.
Participants took part in the study at 54 investigative sites in Canada, United States, Austria, France, Germany, Italy, Netherlands, Spain, Sweden, China, Hong Kong, Japan, Korea, Taiwan, and Australia from 31 January 2019 to 21 August 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brigatinib 90 mg/180mg With Optional Dose Escalation to 240 mg | Participants received brigatinib 90 mg, tablets, orally, once daily (QD) for 7 days, followed by brigatinib 180 mg, tablets, orally, QD for until objective disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as assessed by the investigator, or intolerable toxicity. Participants who experienced progression on the 180 mg dose and had not experienced toxicities greater than Grade 2 had the option to receive brigatinib 240 mg QD based on investigator's discretion, up to 28 months from start of enrollment until data cut-off: 20 May 2021. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 12, 2021 | Jun 10, 2025 |
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| Up to approximately 28 months |
| Duration of Response (DOR) as Assessed by the IRC and the Investigator | DOR is defined as the time interval from the time that the measurement criteria are first met for CR or PR until the first date that the progressive disease (PD) is objectively documented, or death. CR: disappearance of all extranodal target lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. PR: at least a 30% decrease in the SLD of target lesions taking as reference the Baseline sum diameters. PD: SLD increased by at least 20% from the smallest value on study (including Baseline, if that is the smallest). SLD must also demonstrate an absolute increase of at least 5 mm (2 lesions increasing from, for example, 2 mm to 3 mm, does not qualify). | Up to approximately 28 months |
| Progression-Free Survival (PFS) as Assessed by the IRC and the Investigator | PFS is defined as the time interval from the date of the first dose of the study treatment until the first date at which disease progression is objectively documented, or death due to any cause, whichever occurs first. PFS was censored for participants without documented disease progression or death. | Up to approximately 28 Months |
| Disease Control Rate (DCR) as Assessed by the IRC and the Investigator | DCR is defined as the percentage of participants who have achieved CR, PR or stable disease (SD) (in the case of SD, measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks) after the initiation of study treatment. CR: disappearance of all extranodal target lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. PR: at least a 30% decrease in the SLD of target lesions taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Percentages were rounded off to the nearest single decimal place. | Up to approximately 28 months |
| Time to Response as Assessed by the IRC and the Investigator | Time to response is defined as the time interval from the date of the first dose of the study treatment until the initial observation of CR or PR. CR: disappearance of all extranodal target lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. PR: at least a 30% decrease in the SLD of target lesions taking as reference the baseline sum diameters. | Up to approximately 28 months |
| Confirmed Intracranial Objective Response Rate (iORR) in Participants With Brain Metastases at Baseline, as Assessed by the IRC | Confirmed iORR is defined as the percentage of the participants who have achieved CR or PR in the brain per a modification of RECIST version 1.1, after the initiation of study treatment, in participants with intracranial brain metastases at baseline. CR: disappearance of all extranodal target lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. or partial response or PR: at least a 30% decrease in the SLD of target lesions taking as reference the baseline sum diameters. Percentages were rounded off to the nearest single decimal place. | Up to approximately 28 months |
| Duration of Intracranial Response in Participants With Brain Metastases at Baseline, as Assessed by the IRC | Duration of intracranial response is defined as the time interval from the time that the measurement criteria are first met for CR or PR until the first date that PD (including baseline, if that is the smallest). SLD must also demonstrate an absolute increase of at least 5 mm. (2 lesions increasing from, for example, 2 mm to 3 mm, does not qualify) in the brain is objectively documented or death, in participants with intracranial metastases at baseline. CR: disappearance of all extranodal target lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. or partial response or PR: at least a 30% decrease in the SLD of target lesions taking as reference the baseline sum diameters in the brain. PD: SLD increased by at least 20% from the smallest value on study. | Up to approximately 28 months |
| Intracranial Progression-Free Survival (iPFS) in Participants With Brain Metastases at Baseline, as Assessed by the IRC | iPFS is defined as the time interval from the date of the first dose of the study treatment until the first date at which intracranial brain disease progression is objectively documented, or death due to any cause, whichever occurs first, in participants with intracranial metastases at enrollment. iPFS will be censored for participants without documented intracranial disease progression or death. | Up to approximately 28 months |
| Overall Survival (OS) | OS is defined as the time interval from the date of the first dose of the study treatment until death due to any cause. It was censored on the date of last contact for those participants who were alive. | Up to approximately 28 months |
| Number of Participants With One or More Treatment-emergent Adverse Event (TEAE) | An adverse event (AE) means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. This includes any newly occurring event, or a previous condition that has increased in severity or frequency since the administration of study drug. TEAE: any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug. | First dose of study drug up to 30 days after last dose (approximately 5 years) |
| Number of Participants With Improvement in Health-Related Quality of Life (HRQOL) Based on European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score | EORTC QLQ-C30 incorporates 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). EORTC QLQ-C30 contains 28 questions (4-point scale where 1=Not at all [best] to 4=Very Much [worst]) and 2 questions (7-point scale where 1=Very poor [worst] to 7= Excellent [best]). Raw scores are converted into scale scores ranging from 0 to 100. For the functional scales and the global health status scale, higher scores represent better quality of life (QOL); for the symptom scales, lower scores represent better QOL. Improvement is defined as a change from baseline of 10 or more points higher for functional scales and 10 or more points lower for symptom scales. | Up to approximately 28 months |
| Number of Participants With Improvement of HRQOL Based on EORTC QLQ- Lung Cancer (LC) 13 | HRQOL scores will be assessed with EORTC, its lung cancer module QLQ-LC13. QLQ-LC13 contains 13 questions assessing lung cancer-associated symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and use of pain medication. Scale score range: 0 to 100. Higher symptom score = greater degree of symptom severity. Improvement is defined as a change from baseline of 10 or more points lower for symptom scales. | Up to approximately 28 months |
| 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 | St 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 1Z2 | Canada |
| Tom Baker Cancer Center | Calgary | British Columbia | T2N 2T9 | Canada |
| Toronto University Health Network | Toronto | Ontario | M5G 2M9 | Canada |
| McGill University Health Centre | Montreal | Quebec | H4A 3J1 | Canada |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100000 | China |
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510000 | China |
| Jilin Provincial Cancer Hospital (Changchun Cancer Hospital) | Changchun | Jilin | 130000 | China |
| Shanghai Pulmonary Hospital | Shanghai | Shanghai Municipality | 200001 | China |
| The First Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310000 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310000 | China |
| Hopital Haut-Leveque | Pessac | Aquitaine | 33604 | France |
| Centre de Lutte Contre le Cancer Centre Leon Berard | Lyon | Auvergne-Rhône-Alpes | 69008 | France |
| Hopital Larrey, CHU de Toulouse, Service de Pneumologie | Toulouse | Midi-pyrenees | 31059 | France |
| Assistance Publique-Hopitaux de Marseille Hopital Nord | Marseille | Provence-Alpes-Côte d'Azur Region | 13915 | France |
| Centre Hospitalier Intercommunal de Creteil | Créteil | Île-de-France Region | 94010 | France |
| Thoraxklinik Heidelberg gGmbH | Heidelberg | Baden-Wurttemberg | 69126 | Germany |
| Universitatsklinikum Ulm | Ulm | Baden-Wurttemberg | 89081 | Germany |
| Klinikum Kempten-Oberallgau | Kempten (Allgäu) | Bavaria | 87439 | Germany |
| Ludwig-Maximilians-Universitat Munchen | München | Bavaria | 80336 | Germany |
| Pius Hospital Oldenburg | Oldenburg | Lower Saxony | 26121 | Germany |
| Evangelisches Krankenhaus Hamm | Hamm | North Rhine-Westphalia | 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 | Rome | 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 | Milan | 20141 | Italy |
| Istituto Nazionale Tumori IRCCS Fondazione Pascale | Naples | 80131 | Italy |
| Azienda Ospedaliero Universitaria di Parma | Parma | 43126 | Italy |
| Azienda USL della Romagna | Ravenna | 48121 | Italy |
| Fujita Health University Hospital | Toyoake | Aichi-ken | 470-1192 | Japan |
| Kanagawa Cancer Center | Yokohama | Kanagawa | 241-8515 | Japan |
| Sendai Kousei Hospital | Sendai | Miyagi | 980-0873 | Japan |
| Okayama University Hospital | Okayama | Okayama-ken | 700-8558 | Japan |
| Kansai Medical University Hirakata Hospital | Hirakata-shi | Osaka | 573-1191 | Japan |
| The Cancer Institute Hospital of Japanese Foundation for Cancer Research | Koto-ku | Tokyo | 135-8550 | Japan |
| Maastricht University Medical Centre | Maastricht | Limburg | 6229 HX | Netherlands |
| Vrije Universiteit Medisch Centrum | Amsterdam | North Holland | 1081 HV | Netherlands |
| Erasmus University Medical Center | Rotterdam | South Holland | 3015 CE | Netherlands |
| National Cancer Center | Goyang-si | Gyeonggi-do | 411-769 | South Korea |
| Gachon University Gil Medical Center | Incheon | Gyeonggi-do | 21565 | South Korea |
| Korea University Anam Hospital | Seoul | Gyeonggi-do | 02841 | South Korea |
| Chungbuk National University Hospital | Cheongju-si | Gyeongsangbuk-do | 28644 | South Korea |
| Keimyung University Dongsan Medical Center | Daegu | 41931 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| Institut Catala d'Oncologia Badalona - Hospital Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Complejo Hospitalario Universitario A Coruna | A Coruña | 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 | Skåne County | 214 01 | Sweden |
| Karolinska Universitetssjukhuset | Stockholm | 171 76 | Sweden |
| Uppsala Akademiska Sjukhus | Uppsala | 751 85 | Sweden |
| Changhua Christian Hospital | Changhua | 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 |
| Ou SI, Nishio M, Ahn MJ, Mok T, Barlesi F, Zhou C, Felip E, de Marinis F, Kim SW, Perol M, Liu G, Migliorino MR, Kim DW, Novello S, Bearz A, Garrido P, Mazieres J, Morabito A, Lin HM, Yang H, Niu H, Zhang P, Kim ES. Efficacy of Brigatinib in Patients With Advanced ALK-Positive NSCLC Who Progressed on Alectinib or Ceritinib: ALK in Lung Cancer Trial of brigAtinib-2 (ALTA-2). J Thorac Oncol. 2022 Dec;17(12):1404-1414. doi: 10.1016/j.jtho.2022.08.018. Epub 2022 Sep 10. |
| 33569983 | Derived | Kim ES, Barlesi F, Mok T, Ahn MJ, Shen J, Zhang P, Ou SI. ALTA-2: Phase II study of brigatinib in patients with ALK-positive, advanced non-small-cell lung cancer who progressed on alectinib or ceritinib. Future Oncol. 2021 May;17(14):1709-1719. doi: 10.2217/fon-2020-1119. Epub 2021 Feb 11. |
| Participants Who Received Escalated Dose of Brigatinib 240 mg |
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| COMPLETED |
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| NOT COMPLETED |
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|
Full Analysis Population included all participants who received at least 1 dose of brigatinib.
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| ID | Title | Description |
|---|---|---|
| BG000 | Brigatinib 90 mg/180 mg With Optional Dose Escalation to 240 mg | Participants received brigatinib 90 mg, tablets, orally, QD for 7 days, followed by brigatinib 180 mg, tablets, orally, QD for until objective disease progression per RECIST version 1.1, as assessed by the investigator, or intolerable toxicity. Participants who experienced progression on the 180 mg dose and had not experienced toxicities greater than Grade 2 had the option to receive brigatinib 240 mg QD based on investigator's discretion, up to 28 months from start of enrollment until data cut-off: 20 May 2021. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| Weight | Number analyzed signifies the number of participants with data available for weight. | Mean | Standard Deviation | kilograms (kg) |
| ||||||||||||||||
| Height | Number analyzed signifies the number of participants with data available for height. | Mean | Standard Deviation | centimeters (cm) |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Confirmed Objective Response Rate (ORR) Using RECIST v1.1 as Assessed by the Independent Review Committee (IRC) | Confirmed ORR is defined as the percentage of the participants who are confirmed to have achieved complete response (CR) or partial response (PR), per RECIST version 1.1 (confirmed ≥4 weeks after initial response), after the initiation of study treatment. CR: disappearance of all extranodal target lesions and all pathological lymph nodes must have decreased to <10 mm in short axis and PR: at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions taking as reference the Baseline sum diameters. Percentages were rounded off to the nearest single decimal place. | Full Analysis Population included all participants who received at least 1 dose of brigatinib. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 20 months from the start of enrollment till data cut-off 30 September 2020 |
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| Secondary | Confirmed ORR Using RECIST v1.1 as Assessed by the Investigator | Confirmed ORR is defined as the percentage of the participants who are confirmed to have achieved CR or PR, per RECIST version 1.1 (confirmed ≥4 weeks after initial response), after the initiation of study treatment. CR: disappearance of all extranodal target lesions and all pathological lymph nodes must have decreased to <10 mm in short axis and PR: at least a 30% decrease in the SLD of target lesions taking as reference the baseline sum diameters. Percentages were rounded off to the nearest single decimal place. | Full Analysis Population included all participants who received at least 1 dose of brigatinib. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 28 months |
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| Secondary | Duration of Response (DOR) as Assessed by the IRC and the Investigator | DOR is defined as the time interval from the time that the measurement criteria are first met for CR or PR until the first date that the progressive disease (PD) is objectively documented, or death. CR: disappearance of all extranodal target lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. PR: at least a 30% decrease in the SLD of target lesions taking as reference the Baseline sum diameters. PD: SLD increased by at least 20% from the smallest value on study (including Baseline, if that is the smallest). SLD must also demonstrate an absolute increase of at least 5 mm (2 lesions increasing from, for example, 2 mm to 3 mm, does not qualify). | Full Analysis Population included all participants who received at least 1 dose of brigatinib. Overall number of participants analyzed is the number of participants who were responders. | Posted | Median | 95% Confidence Interval | months | Up to approximately 28 months |
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| Secondary | Progression-Free Survival (PFS) as Assessed by the IRC and the Investigator | PFS is defined as the time interval from the date of the first dose of the study treatment until the first date at which disease progression is objectively documented, or death due to any cause, whichever occurs first. PFS was censored for participants without documented disease progression or death. | Full Analysis Population included all participants who received at least 1 dose of brigatinib. | Posted | Median | 95% Confidence Interval | months | Up to approximately 28 Months |
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| Secondary | Disease Control Rate (DCR) as Assessed by the IRC and the Investigator | DCR is defined as the percentage of participants who have achieved CR, PR or stable disease (SD) (in the case of SD, measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks) after the initiation of study treatment. CR: disappearance of all extranodal target lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. PR: at least a 30% decrease in the SLD of target lesions taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Percentages were rounded off to the nearest single decimal place. | Full Analysis Population included all participants who received at least 1 dose of brigatinib. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 28 months |
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| Secondary | Time to Response as Assessed by the IRC and the Investigator | Time to response is defined as the time interval from the date of the first dose of the study treatment until the initial observation of CR or PR. CR: disappearance of all extranodal target lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. PR: at least a 30% decrease in the SLD of target lesions taking as reference the baseline sum diameters. | Full Analysis Population included all participants who received at least 1 dose of brigatinib. Overall number of participants analyzed is the number of participants who were responders. | Posted | Median | Full Range | months | Up to approximately 28 months |
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| Secondary | Confirmed Intracranial Objective Response Rate (iORR) in Participants With Brain Metastases at Baseline, as Assessed by the IRC | Confirmed iORR is defined as the percentage of the participants who have achieved CR or PR in the brain per a modification of RECIST version 1.1, after the initiation of study treatment, in participants with intracranial brain metastases at baseline. CR: disappearance of all extranodal target lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. or partial response or PR: at least a 30% decrease in the SLD of target lesions taking as reference the baseline sum diameters. Percentages were rounded off to the nearest single decimal place. | Intracranial central nervous system (iCNS) disease population included those participants in the Full Analysis Population who were determined by the IRC to have iCNS metastases at baseline, regardless of whether they had at least 1 lesion that qualified as a target lesion in their baseline assessment by the IRC. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 28 months |
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| Secondary | Duration of Intracranial Response in Participants With Brain Metastases at Baseline, as Assessed by the IRC | Duration of intracranial response is defined as the time interval from the time that the measurement criteria are first met for CR or PR until the first date that PD (including baseline, if that is the smallest). SLD must also demonstrate an absolute increase of at least 5 mm. (2 lesions increasing from, for example, 2 mm to 3 mm, does not qualify) in the brain is objectively documented or death, in participants with intracranial metastases at baseline. CR: disappearance of all extranodal target lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. or partial response or PR: at least a 30% decrease in the SLD of target lesions taking as reference the baseline sum diameters in the brain. PD: SLD increased by at least 20% from the smallest value on study. | iCNS disease population included those participants in the Full Analysis Population who were determined by the IRC to have iCNS metastases at baseline, regardless of whether they had at least 1 lesion that qualified as a target lesion in their baseline assessment by the IRC. Overall number of participants analyzed is the number of participants who were responders. | Posted | Median | 95% Confidence Interval | months | Up to approximately 28 months |
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| Secondary | Intracranial Progression-Free Survival (iPFS) in Participants With Brain Metastases at Baseline, as Assessed by the IRC | iPFS is defined as the time interval from the date of the first dose of the study treatment until the first date at which intracranial brain disease progression is objectively documented, or death due to any cause, whichever occurs first, in participants with intracranial metastases at enrollment. iPFS will be censored for participants without documented intracranial disease progression or death. | iCNS disease population included of those participants in the Full Analysis Population who were determined by the IRC to have iCNS metastases at baseline, regardless of whether they had at least 1 lesion that qualified as a target lesion in their baseline assessment by the IRC. | Posted | Median | 95% Confidence Interval | months | Up to approximately 28 months |
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| Secondary | Overall Survival (OS) | OS is defined as the time interval from the date of the first dose of the study treatment until death due to any cause. It was censored on the date of last contact for those participants who were alive. | Full Analysis Population included all participants who received at least 1 dose of brigatinib. | Posted | Median | 95% Confidence Interval | months | Up to approximately 28 months |
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| Secondary | Number of Participants With One or More Treatment-emergent Adverse Event (TEAE) | An adverse event (AE) means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. This includes any newly occurring event, or a previous condition that has increased in severity or frequency since the administration of study drug. TEAE: any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug. | Safety Analysis Population included all participants who received at least 1 dose of brigatinib. As pre-specified in protocol, AEs are reported for 2 sets/arms. Arm 1 (brigatinib 90/180 mg) and Arm 2 (brigatinib 240 mg). | Posted | Count of Participants | Participants | First dose of study drug up to 30 days after last dose (approximately 5 years) |
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| Secondary | Number of Participants With Improvement in Health-Related Quality of Life (HRQOL) Based on European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score | EORTC QLQ-C30 incorporates 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). EORTC QLQ-C30 contains 28 questions (4-point scale where 1=Not at all [best] to 4=Very Much [worst]) and 2 questions (7-point scale where 1=Very poor [worst] to 7= Excellent [best]). Raw scores are converted into scale scores ranging from 0 to 100. For the functional scales and the global health status scale, higher scores represent better quality of life (QOL); for the symptom scales, lower scores represent better QOL. Improvement is defined as a change from baseline of 10 or more points higher for functional scales and 10 or more points lower for symptom scales. | Full Analysis Population included all participants who received at least 1 dose of brigatinib. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis for the specified category. | Posted | Count of Participants | Participants | Up to approximately 28 months |
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| Secondary | Number of Participants With Improvement of HRQOL Based on EORTC QLQ- Lung Cancer (LC) 13 | HRQOL scores will be assessed with EORTC, its lung cancer module QLQ-LC13. QLQ-LC13 contains 13 questions assessing lung cancer-associated symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and use of pain medication. Scale score range: 0 to 100. Higher symptom score = greater degree of symptom severity. Improvement is defined as a change from baseline of 10 or more points lower for symptom scales. | Full Analysis Population included all participants who received at least 1 dose of brigatinib. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis for the specified category. | Posted | Count of Participants | Participants | Up to approximately 28 months |
|
First dose of study drug up to 30 days after last dose (approximately 5 years)
Safety Analysis Population: participants who received at least 1 dose of brigatinib. As pre-specified in protocol all-cause mortality and AEs are reported separately for 2 sets/arms: Arm 1 (brigatinib 90/180 mg) and Arm 2 (brigatinib 240 mg).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brigatinib 90/180 mg | Participants received brigatinib 90 mg, tablets, orally, QD for 7 days, followed by brigatinib 180 mg, tablets, orally, QD for until objective disease progression per RECIST version 1.1, as assessed by the investigator, or intolerable toxicity. Participants who experienced progression on the 180 mg dose and had not experienced toxicities greater than Grade 2 had the option to receive brigatinib 240 mg QD based on investigator's discretion, up to 28 months from start of enrollment until data cut-off: 20 May 2021. | 39 | 103 | 48 | 103 | 98 | 103 |
| EG001 | Brigatinib 240 mg | Participants who experienced progression on the 180 mg dose and had not experienced toxicities greater than Grade 2 had the option to receive brigatinib 240 mg QD from start of enrolment based on investigator's discretion up to data-cut off: 30 September 2020 (approximately 20 months). Participants who experienced progression on any doses but judged as still benefiting from the study treatment by the investigator may continue to use the current dose, up to study end. | 5 | 13 | 3 | 13 | 12 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bronchial haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Complication of device insertion | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Craniofacial fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Duodenal obstruction | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hospitalisation | Surgical and medical procedures | MedDRA 27.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Malignant pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Metastases to biliary tract | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Moyamoya disease | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary artery thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Anal haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertrophic cardiomyopathy | Congenital, familial and genetic disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Persistent depressive disorder | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Swelling face | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Tunnel vision | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 5, 2020 | Sep 24, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000598580 | brigatinib |
Not provided
Not provided
Not provided
|
| Unknown or Not Reported |
|
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
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| Unknown or Not Reported |
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| Austria |
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| France |
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| Germany |
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| Italy |
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| Netherlands |
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| Spain |
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| Sweden |
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| China |
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| Hong Kong |
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| Japan |
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| Korea, South |
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| Taiwan, Province Of China |
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| Australia |
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| Participants |
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| Participants |
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| Participants |
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| OG001 | Brigatinib 240 mg | Participants who experienced progression on the 180 mg dose and had not experienced toxicities greater than Grade 2 had the option to receive brigatinib 240 mg QD from start of enrollment based on investigator's discretion up to data-cut off: 20 May 2021 (approximately 28 months). Participants who experienced progression on any doses but judged as still benefiting from the study treatment by the investigator continued to use the current dose, up to study end. |
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| Participants |
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