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A Study of Brigatinib in Participants With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib (ALTA-2)

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ClinicalTrials.gov Identifier: NCT03535740
Recruitment Status : Active, not recruiting
First Posted : May 24, 2018
Results First Posted : October 25, 2021
Last Update Posted : January 5, 2022
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Takeda ( Ariad Pharmaceuticals )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition ALK-positive Advanced NSCLC
Intervention Drug: Brigatinib
Enrollment 103
Recruitment Details 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 data cut-off date: 30 September 2020. This study is ongoing.
Pre-assignment Details Participants with a diagnosis of anaplastic lymphoma kinase-positive (ALK+), advanced non-small-cell lung cancer (NSCLC) were enrolled in single arm to receive brigatinib 90 mg followed by 180 mg up to disease progression.
Arm/Group Title Brigatinib 90 mg/180 mg With Optional Dose Escalation to 240 mg
Hide Arm/Group Description Brigatinib 90 mg, tablets, orally, once daily for 7 days, followed by Brigatinib 180 mg, tablets, orally, once daily 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 from start of enrollment 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.
Period Title: Overall Study
Started 103
Participants Who Received Escalated Dose of Brigatinib 240 mg 13
Completed 0
Not Completed 103
Reason Not Completed
Ongoing at Data Cut-off Date: 30 September 2020             55
Death             34
Lost to Follow-up             1
Withdrawal by Subject             13
Arm/Group Title Brigatinib 90 mg/180 mg With Optional Dose Escalation to 240 mg
Hide Arm/Group Description Brigatinib 90 mg, tablets, orally, once daily for 7 days, followed by Brigatinib 180 mg, tablets, orally, once daily 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 from start of enrollment 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.
Overall Number of Baseline Participants 103
Hide Baseline Analysis Population Description
Full Analysis Set (FAS) included all participants who received at least 1 dose of brigatinib.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 103 participants
54.7  (11.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants
Female
52
  50.5%
Male
51
  49.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants
Hispanic or Latino
2
   1.9%
Not Hispanic or Latino
92
  89.3%
Unknown or Not Reported
9
   8.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants
American Indian or Alaska Native
0
   0.0%
Asian
49
  47.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   1.0%
White
44
  42.7%
More than one race
0
   0.0%
Unknown or Not Reported
9
   8.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Canada Number Analyzed 103 participants
6
United States Number Analyzed 103 participants
7
Austria Number Analyzed 103 participants
1
France Number Analyzed 103 participants
7
Germany Number Analyzed 103 participants
3
Italy Number Analyzed 103 participants
16
Netherlands Number Analyzed 103 participants
2
Spain Number Analyzed 103 participants
11
Sweden Number Analyzed 103 participants
2
China Number Analyzed 103 participants
14
Hong Kong Number Analyzed 103 participants
6
Japan Number Analyzed 103 participants
3
South Korea Number Analyzed 103 participants
20
Taiwan Number Analyzed 103 participants
4
Australia Number Analyzed 103 participants
1
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 102 participants
69.23  (15.409)
[1]
Measure Analysis Population Description: Number analyzed signifies the number of participants with data available for weight.
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 100 participants
165.86  (10.172)
[1]
Measure Analysis Population Description: Number analyzed signifies the number of participants with data available for height.
1.Primary Outcome
Title Confirmed Objective Response Rate (ORR) Using RECIST v1.1 as Assessed by the Independent Review Committee (IRC)
Hide Description 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.
Time Frame Up to approximately 20 months from start of enrollment till data cut-off: 30 September 2020
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of brigatinib.
Arm/Group Title Brigatinib 90 mg/180 mg With Optional Dose Escalation to 240 mg
Hide Arm/Group Description:
Brigatinib 90 mg, tablets, orally, once daily for 7 days, followed by Brigatinib 180 mg, tablets, orally, once daily 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 from start of enrollment 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.
Overall Number of Participants Analyzed 103
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
26.2
(18.0 to 35.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brigatinib 90 mg/180 mg With Optional Dose Escalation to 240 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0763
Comments [Not Specified]
Method Exact Binomial Test
Comments The calculation was based on an exact binomial test with a total 1-sided alpha level of 0.025 at primary analysis.
2.Secondary Outcome
Title Confirmed ORR Using RECIST v1.1 as Assessed by the Investigator
Hide Description 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.
Time Frame Until the radiological disease progression or study end (approximately 3 years)
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Duration of Response (DOR) as Assessed by the Investigator and IRC
Hide Description 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).
Time Frame Until the radiological disease progression or study end (approximately 3 years)
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Progression-Free Survival (PFS) as Assessed by the Investigator and IRC
Hide Description 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 will be censored for participants without documented disease progression or death.
Time Frame Until the radiological disease progression or study end (approximately 3 years)
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Disease Control Rate (DCR) as Assessed by the Investigator and IRC
Hide Description 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.
Time Frame Until the radiological disease progression or study end (approximately 3 years)
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Time to Response as Assessed by the Investigator and IRC
Hide Description 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.
Time Frame Until the radiological disease progression or study end (approximately 3 years)
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Confirmed Intracranial Objective Response Rate (iORR) in Participants With Brain Metastases at Baseline, as Assessed by the IRC
Hide Description Confirmed iORR is defined as the proportion 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.
Time Frame Until the radiological disease progression or study end (approximately 3 years)
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Duration of Intracranial Response in Participants With Brain Metastases at Baseline, as Assessed by the IRC
Hide Description 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.
Time Frame Until the radiological disease progression or study end (approximately 3 years)
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Intracranial Progression-Free Survival (iPFS) in Participants With Brain Metastases at Baseline, as Assessed by the IRC
Hide Description 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.
Time Frame Until the radiological disease progression or study end (approximately 3 years)
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Overall Survival (OS)
Hide Description 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 will be censored on the date of last contact for those participants who are alive.
Time Frame Until the radiological disease progression or study end (approximately 3 years)
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Number of Participants With One or More Treatment-emergent Adverse Event (TEAE)
Hide Description 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.
Time Frame First dose of study drug up to 30 days after last dose (approximately 3 years)
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Health-Related Quality of Life (HRQOL) From European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score
Hide Description 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.
Time Frame First dose of study drug up to 30 days after last dose (approximately 3 years)
Outcome Measure Data Not Reported
13.Secondary Outcome
Title HRQOL From EORTC QLQ- Lung Cancer (LC) 13
Hide Description 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.
Time Frame First dose of study drug up to 30 days after last dose (approximately 3 years)
Outcome Measure Data Not Reported
Time Frame Up to data cut-off date: 30 September 2020 (approximately 20 months from first dose of study treatment (Brigatinib 90/180 mg or Brigatinib 240 mg))
Adverse Event Reporting Description As pre-specified in protocol, AEs are reported for 2 sets/arms. Arm 1 (Brigatinib 90/180 mg) has AEs in participants who received brigatinib 90/180 mg from first dose of study treatment for all participants till 30 days after last dose, if participant discontinues/do not escalate to 240 mg dose. Arm 2 (brigatinib 240 mg) has AEs in participants who had brigatinib dose-escalated to 240 mg from date of escalation to 240 mg QD up to 30 days post last dose until data cut-off date: 30 September 2020.
 
Arm/Group Title Brigatinib 90 mg/180 mg Brigatinib 240 mg
Hide Arm/Group Description Brigatinib 90 mg, tablets, orally, once daily for 7 days, followed by Brigatinib 180 mg, tablets, orally, once daily for until objective disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as assessed by the investigator, or intolerable toxicity Up to approximately 20 months from start of enrollment till 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. Participants who experienced progression on the 180 mg dose and had not experienced toxicities greater than Grade 2 had the option from start of enrollment to receive brigatinib 240 mg QD 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.
All-Cause Mortality
Brigatinib 90 mg/180 mg Brigatinib 240 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   31/103 (30.10%)   3/13 (23.08%) 
Hide Serious Adverse Events
Brigatinib 90 mg/180 mg Brigatinib 240 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   47/103 (45.63%)   2/13 (15.38%) 
Blood and lymphatic system disorders     
Neutropenia † 1  1/103 (0.97%)  0/13 (0.00%) 
Thrombocytopenia † 1  1/103 (0.97%)  0/13 (0.00%) 
Cardiac disorders     
Atrial flutter † 1  1/103 (0.97%)  0/13 (0.00%) 
Cardiac arrest † 1  1/103 (0.97%)  0/13 (0.00%) 
Cardiac failure † 1  1/103 (0.97%)  0/13 (0.00%) 
Gastrointestinal disorders     
Duodenal obstruction † 1  1/103 (0.97%)  0/13 (0.00%) 
Intestinal obstruction † 1  1/103 (0.97%)  0/13 (0.00%) 
General disorders     
Pyrexia † 1  2/103 (1.94%)  0/13 (0.00%) 
Death † 1  1/103 (0.97%)  0/13 (0.00%) 
Fatigue † 1  1/103 (0.97%)  0/13 (0.00%) 
General physical health deterioration † 1  1/103 (0.97%)  0/13 (0.00%) 
Pain † 1  1/103 (0.97%)  0/13 (0.00%) 
Peripheral swelling † 1  1/103 (0.97%)  0/13 (0.00%) 
Infections and infestations     
Pneumonia † 1  4/103 (3.88%)  0/13 (0.00%) 
Abdominal sepsis † 1  1/103 (0.97%)  0/13 (0.00%) 
Appendicitis † 1  1/103 (0.97%)  0/13 (0.00%) 
Cellulitis † 1  1/103 (0.97%)  0/13 (0.00%) 
Infectious pleural effusion † 1  1/103 (0.97%)  0/13 (0.00%) 
Meningitis † 1  1/103 (0.97%)  0/13 (0.00%) 
Respiratory tract infection † 1  1/103 (0.97%)  0/13 (0.00%) 
Sepsis † 1  1/103 (0.97%)  0/13 (0.00%) 
Injury, poisoning and procedural complications     
Facial bones fracture † 1  1/103 (0.97%)  0/13 (0.00%) 
Investigations     
Liver function test abnormal † 1  1/103 (0.97%)  0/13 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite † 1  1/103 (0.97%)  0/13 (0.00%) 
Gout † 1  1/103 (0.97%)  0/13 (0.00%) 
Hypercalcaemia † 1  1/103 (0.97%)  0/13 (0.00%) 
Hyperglycaemia † 1  1/103 (0.97%)  0/13 (0.00%) 
Hyperkalaemia † 1  1/103 (0.97%)  0/13 (0.00%) 
Hyponatraemia † 1  1/103 (0.97%)  0/13 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  1/103 (0.97%)  0/13 (0.00%) 
Back pain † 1  1/103 (0.97%)  0/13 (0.00%) 
Intervertebral disc protrusion † 1  1/103 (0.97%)  0/13 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung neoplasm malignant † 1  2/103 (1.94%)  0/13 (0.00%) 
Malignant pleural effusion † 1  2/103 (1.94%)  0/13 (0.00%) 
Non-small cell lung cancer † 1  2/103 (1.94%)  0/13 (0.00%) 
Cancer pain † 1  1/103 (0.97%)  0/13 (0.00%) 
Metastases to central nervous system † 1  1/103 (0.97%)  0/13 (0.00%) 
Metastases to meninges † 1  1/103 (0.97%)  0/13 (0.00%) 
Neoplasm progression † 1  1/103 (0.97%)  0/13 (0.00%) 
Tumour associated fever † 1  1/103 (0.97%)  0/13 (0.00%) 
Nervous system disorders     
Cerebral haemorrhage † 1  2/103 (1.94%)  0/13 (0.00%) 
Epilepsy † 1  2/103 (1.94%)  0/13 (0.00%) 
Seizure † 1  2/103 (1.94%)  0/13 (0.00%) 
Ischaemic stroke † 1  1/103 (0.97%)  0/13 (0.00%) 
Moyamoya disease † 1  1/103 (0.97%)  0/13 (0.00%) 
Sciatica † 1  1/103 (0.97%)  0/13 (0.00%) 
Spinal cord compression † 1  1/103 (0.97%)  0/13 (0.00%) 
Paraesthesia † 1  0/103 (0.00%)  1/13 (7.69%) 
Renal and urinary disorders     
Dysuria † 1  0/103 (0.00%)  1/13 (7.69%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea † 1  4/103 (3.88%)  0/13 (0.00%) 
Pneumonitis † 1  2/103 (1.94%)  0/13 (0.00%) 
Bronchial haemorrhage † 1  1/103 (0.97%)  0/13 (0.00%) 
Pleural effusion † 1  1/103 (0.97%)  0/13 (0.00%) 
Pulmonary artery thrombosis † 1  1/103 (0.97%)  0/13 (0.00%) 
Pulmonary embolism † 1  1/103 (0.97%)  0/13 (0.00%) 
Pulmonary oedema † 1  1/103 (0.97%)  0/13 (0.00%) 
Respiratory failure † 1  1/103 (0.97%)  0/13 (0.00%) 
Surgical and medical procedures     
Hospitalisation † 1  1/103 (0.97%)  0/13 (0.00%) 
Vascular disorders     
Hypertension † 1  2/103 (1.94%)  0/13 (0.00%) 
Deep vein thrombosis † 1  1/103 (0.97%)  0/13 (0.00%) 
Hypovolaemic shock † 1  1/103 (0.97%)  0/13 (0.00%) 
1
Term from vocabulary, MedDRA version 23.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Brigatinib 90 mg/180 mg Brigatinib 240 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   98/103 (95.15%)   10/13 (76.92%) 
Blood and lymphatic system disorders     
Anaemia † 1  9/103 (8.74%)  0/13 (0.00%) 
Cardiac disorders     
Ventricular extrasystoles † 1  0/103 (0.00%)  1/13 (7.69%) 
Congenital, familial and genetic disorders     
Hypertrophic cardiomyopathy † 1  0/103 (0.00%)  1/13 (7.69%) 
Gastrointestinal disorders     
Diarrhoea † 1  40/103 (38.83%)  6/13 (46.15%) 
Nausea † 1  29/103 (28.16%)  1/13 (7.69%) 
Vomiting † 1  18/103 (17.48%)  1/13 (7.69%) 
Constipation † 1  10/103 (9.71%)  1/13 (7.69%) 
Anal haemorrhage † 1  0/103 (0.00%)  1/13 (7.69%) 
General disorders     
Asthenia † 1  12/103 (11.65%)  3/13 (23.08%) 
Pyrexia † 1  12/103 (11.65%)  1/13 (7.69%) 
Oedema peripheral † 1  8/103 (7.77%)  0/13 (0.00%) 
Non-cardiac chest pain † 1  7/103 (6.80%)  0/13 (0.00%) 
Chest pain † 1  4/103 (3.88%)  1/13 (7.69%) 
Fatigue † 1  4/103 (3.88%)  1/13 (7.69%) 
Mucosal inflammation † 1  2/103 (1.94%)  1/13 (7.69%) 
Swelling face † 1  0/103 (0.00%)  1/13 (7.69%) 
Infections and infestations     
Pneumonia † 1  8/103 (7.77%)  0/13 (0.00%) 
Tonsillitis † 1  0/103 (0.00%)  1/13 (7.69%) 
Investigations     
Blood creatine phosphokinase increased † 1  35/103 (33.98%)  4/13 (30.77%) 
Aspartate aminotransferase increased † 1  21/103 (20.39%)  1/13 (7.69%) 
Alanine aminotransferase increased † 1  18/103 (17.48%)  1/13 (7.69%) 
Lipase increased † 1  18/103 (17.48%)  1/13 (7.69%) 
Amylase increased † 1  15/103 (14.56%)  1/13 (7.69%) 
Weight decreased † 1  13/103 (12.62%)  0/13 (0.00%) 
Blood alkaline phosphatase increased † 1  9/103 (8.74%)  0/13 (0.00%) 
Gamma-glutamyltransferase increased † 1  8/103 (7.77%)  0/13 (0.00%) 
Blood cholesterol increased † 1  5/103 (4.85%)  1/13 (7.69%) 
Blood calcium increased † 1  2/103 (1.94%)  1/13 (7.69%) 
Blood bilirubin increased † 1  0/103 (0.00%)  1/13 (7.69%) 
Metabolism and nutrition disorders     
Decreased appetite † 1  11/103 (10.68%)  0/13 (0.00%) 
Hyperglycaemia † 1  9/103 (8.74%)  1/13 (7.69%) 
Hypokalaemia † 1  7/103 (6.80%)  0/13 (0.00%) 
Hyponatraemia † 1  7/103 (6.80%)  0/13 (0.00%) 
Hypertriglyceridaemia † 1  3/103 (2.91%)  1/13 (7.69%) 
Hypophosphataemia † 1  2/103 (1.94%)  1/13 (7.69%) 
Musculoskeletal and connective tissue disorders     
Pain in extremity † 1  13/103 (12.62%)  0/13 (0.00%) 
Back pain † 1  11/103 (10.68%)  0/13 (0.00%) 
Myalgia † 1  7/103 (6.80%)  0/13 (0.00%) 
Musculoskeletal pain † 1  6/103 (5.83%)  1/13 (7.69%) 
Musculoskeletal chest pain † 1  6/103 (5.83%)  0/13 (0.00%) 
Bone pain † 1  1/103 (0.97%)  1/13 (7.69%) 
Nervous system disorders     
Headache † 1  14/103 (13.59%)  1/13 (7.69%) 
Dizziness † 1  10/103 (9.71%)  0/13 (0.00%) 
Paraesthesia † 1  4/103 (3.88%)  1/13 (7.69%) 
Dysgeusia † 1  2/103 (1.94%)  1/13 (7.69%) 
Tunnel vision † 1  0/103 (0.00%)  1/13 (7.69%) 
Psychiatric disorders     
Anxiety † 1  6/103 (5.83%)  1/13 (7.69%) 
Insomnia † 1  3/103 (2.91%)  1/13 (7.69%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1  24/103 (23.30%)  3/13 (23.08%) 
Dyspnoea † 1  12/103 (11.65%)  1/13 (7.69%) 
Skin and subcutaneous tissue disorders     
Rash † 1  8/103 (7.77%)  1/13 (7.69%) 
Skin exfoliation † 1  0/103 (0.00%)  1/13 (7.69%) 
Vascular disorders     
Hypertension † 1  20/103 (19.42%)  2/13 (15.38%) 
1
Term from vocabulary, MedDRA version 23.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Takeda ( Ariad Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT03535740    
Other Study ID Numbers: Brigatinib-2002
2018-000635-27 ( EudraCT Number )
NL66462.078.18 ( Registry Identifier: CCMO )
JapicCTI-194915 ( Registry Identifier: JapicCTI )
First Submitted: May 9, 2018
First Posted: May 24, 2018
Results First Submitted: September 24, 2021
Results First Posted: October 25, 2021
Last Update Posted: January 5, 2022