Trial Outcomes & Findings for Trial of Brigatinib After Treatment With Next-Generation ALK Inhibitors (NCT NCT02706626)
NCT ID: NCT02706626
Last Updated: 2023-01-26
Results Overview
An assessment of the response using RECIST 1.1 per investigator. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.". The enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
Through study completion (average 42 months)
Results posted on
2023-01-26
Participant Flow
Study closed before total enrollment expectations were met.
The clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results. Patient were enrolled in the trial and were assigned based on previous treatment
Participant milestones
| Measure |
Arm A: Brigatinib After Next Generation ALK TKI
Patients with disease progression after next generation ALK TKI
|
Arm B: Patients Disease Progression After First-line Alectinib
Patients were required to have disease progression after first-line alectinib
|
Arm C: Brigatinib 240 mg for Patients With Disease Progression on Brigatinib
Patients had disease progression on standard dose brigatinib and experience disease progression
|
|---|---|---|---|
|
Overall Study
STARTED
|
27
|
4
|
1
|
|
Overall Study
COMPLETED
|
27
|
4
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Brigatinib After Treatment With Next-Generation ALK Inhibitors
Baseline characteristics by cohort
| Measure |
Arm C: Brigatinib 240 mg for Patients With Disease Progression on Brigatinib
n=1 Participants
Patients who tolerated standard dose brigatinib and had disease progression could enroll in this cohort
|
Total
n=32 Participants
Total of all reporting groups
|
Cohort A: Disease Progression After Next Generation ALK TK
n=27 Participants
Patients could enroll in this cohort after a next generation ALK TKI (regardless of the number of previous therapies)
|
Cohort B: Disease Progression After Alectinib as First-line Therapy
n=4 Participants
Patients could enroll in this cohort after first-line alectinib
|
|---|---|---|---|---|
|
Age, Customized
Median Age
|
76 years
n=5 Participants
|
56 years
n=4 Participants
|
57 years
n=5 Participants
|
43 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
11 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
16 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
23 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
African American
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Latino or Hispanic
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Through study completion (average 42 months)An assessment of the response using RECIST 1.1 per investigator. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.". The enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results
Outcome measures
| Measure |
Arm A: Brigatinib After Next Generation ALK TKI Regardless of Number of Therapies
n=27 Participants
Patients with disease progression after next generation ALK TKI as first or second-line therapy, regardless of number of therapies
|
Arm B: Brigatinib After First-line Therapy With Alectinib
n=4 Participants
Patient were treated with first-line alectinib and had disease progression
|
Arm C: Brigatinib 240 mg in Patient With Disease Progression on Brigatinib 180 mg Daily
n=4 Participants
Patients had disease control on brigatinib and then experience disease progression and did not have severe toxicities related brigatinib
|
|---|---|---|---|
|
Objective Response Rate
|
9 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Arm A: Brigatinib After Next Generation ALK TKI
Serious events: 8 serious events
Other events: 11 other events
Deaths: 10 deaths
Arm B: Brigatinib After First-line Alectinib
Serious events: 2 serious events
Other events: 1 other events
Deaths: 1 deaths
Arm C: Brigatinib 240 mg in Patients With Disease Progression on Brigatinb
Serious events: 2 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm A: Brigatinib After Next Generation ALK TKI
n=27 participants at risk
Patients had disease progression on any next generation ALK TKI (regardless of the number of lines of therapy)
|
Arm B: Brigatinib After First-line Alectinib
n=4 participants at risk
Patients had disease progression on first line alectinib, and not additional therapies were allowed
|
Arm C: Brigatinib 240 mg in Patients With Disease Progression on Brigatinb
n=4 participants at risk
Patients had disease progression on standard dose brigatinib who tolerated standard dose brigatinib
|
|---|---|---|---|
|
Nervous system disorders
Seizure
|
3.7%
1/27 • Number of events 1 • Patients were followed until disease progression or unacceptable toxicity or withdrawal of consent, on average 1 year
|
0.00%
0/4 • Patients were followed until disease progression or unacceptable toxicity or withdrawal of consent, on average 1 year
|
0.00%
0/4 • Patients were followed until disease progression or unacceptable toxicity or withdrawal of consent, on average 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis, pleural effusion,hemoptysis
|
11.1%
3/27 • Number of events 3 • Patients were followed until disease progression or unacceptable toxicity or withdrawal of consent, on average 1 year
|
25.0%
1/4 • Number of events 1 • Patients were followed until disease progression or unacceptable toxicity or withdrawal of consent, on average 1 year
|
50.0%
2/4 • Number of events 2 • Patients were followed until disease progression or unacceptable toxicity or withdrawal of consent, on average 1 year
|
|
Investigations
Increased CPK
|
7.4%
2/27 • Number of events 2 • Patients were followed until disease progression or unacceptable toxicity or withdrawal of consent, on average 1 year
|
0.00%
0/4 • Patients were followed until disease progression or unacceptable toxicity or withdrawal of consent, on average 1 year
|
0.00%
0/4 • Patients were followed until disease progression or unacceptable toxicity or withdrawal of consent, on average 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle or bone pain
|
3.7%
1/27 • Number of events 1 • Patients were followed until disease progression or unacceptable toxicity or withdrawal of consent, on average 1 year
|
25.0%
1/4 • Number of events 1 • Patients were followed until disease progression or unacceptable toxicity or withdrawal of consent, on average 1 year
|
0.00%
0/4 • Patients were followed until disease progression or unacceptable toxicity or withdrawal of consent, on average 1 year
|
|
Infections and infestations
Sepsis
|
3.7%
1/27 • Number of events 1 • Patients were followed until disease progression or unacceptable toxicity or withdrawal of consent, on average 1 year
|
0.00%
0/4 • Patients were followed until disease progression or unacceptable toxicity or withdrawal of consent, on average 1 year
|
0.00%
0/4 • Patients were followed until disease progression or unacceptable toxicity or withdrawal of consent, on average 1 year
|
Other adverse events
| Measure |
Arm A: Brigatinib After Next Generation ALK TKI
n=27 participants at risk
Patients had disease progression on any next generation ALK TKI (regardless of the number of lines of therapy)
|
Arm B: Brigatinib After First-line Alectinib
n=4 participants at risk
Patients had disease progression on first line alectinib, and not additional therapies were allowed
|
Arm C: Brigatinib 240 mg in Patients With Disease Progression on Brigatinb
n=4 participants at risk
Patients had disease progression on standard dose brigatinib who tolerated standard dose brigatinib
|
|---|---|---|---|
|
Investigations
Lab abnormalities
|
3.7%
1/27 • Number of events 1 • Patients were followed until disease progression or unacceptable toxicity or withdrawal of consent, on average 1 year
|
0.00%
0/4 • Patients were followed until disease progression or unacceptable toxicity or withdrawal of consent, on average 1 year
|
0.00%
0/4 • Patients were followed until disease progression or unacceptable toxicity or withdrawal of consent, on average 1 year
|
|
General disorders
Anrorexia fatigue,
|
3.7%
1/27 • Number of events 1 • Patients were followed until disease progression or unacceptable toxicity or withdrawal of consent, on average 1 year
|
0.00%
0/4 • Patients were followed until disease progression or unacceptable toxicity or withdrawal of consent, on average 1 year
|
0.00%
0/4 • Patients were followed until disease progression or unacceptable toxicity or withdrawal of consent, on average 1 year
|
|
Nervous system disorders
Headaches, dizzimes
|
3.7%
1/27 • Number of events 1 • Patients were followed until disease progression or unacceptable toxicity or withdrawal of consent, on average 1 year
|
0.00%
0/4 • Patients were followed until disease progression or unacceptable toxicity or withdrawal of consent, on average 1 year
|
0.00%
0/4 • Patients were followed until disease progression or unacceptable toxicity or withdrawal of consent, on average 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough, shortness of breath, dsypnea, upper respiratory infection
|
14.8%
4/27 • Number of events 4 • Patients were followed until disease progression or unacceptable toxicity or withdrawal of consent, on average 1 year
|
0.00%
0/4 • Patients were followed until disease progression or unacceptable toxicity or withdrawal of consent, on average 1 year
|
0.00%
0/4 • Patients were followed until disease progression or unacceptable toxicity or withdrawal of consent, on average 1 year
|
|
Renal and urinary disorders
Increased creatinine
|
14.8%
4/27 • Number of events 4 • Patients were followed until disease progression or unacceptable toxicity or withdrawal of consent, on average 1 year
|
25.0%
1/4 • Number of events 1 • Patients were followed until disease progression or unacceptable toxicity or withdrawal of consent, on average 1 year
|
25.0%
1/4 • Number of events 1 • Patients were followed until disease progression or unacceptable toxicity or withdrawal of consent, on average 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place