Trial Outcomes & Findings for Study for Patients Previously Treated in Avapritinib Clinical Trials (NCT NCT04825574)
NCT ID: NCT04825574
Last Updated: 2024-11-26
Results Overview
AESIs for avapritinib are, regardless of grade or causality: * cognitive effects which include the following terms: memory impairment, cognitive disorder, confusional state and encephalopathy. * intracranial bleeding including haemorrhage intracranial, cerebral haemorrhage , and subdural haematoma.
COMPLETED
PHASE4
2 participants
From date of first avapritinib dose through 30 days after the last avapritinib dose (up to approximately 31 months)
2024-11-26
Participant Flow
Two participants (one from BLU-285-1101 (NCT02508532) and one from BLU-285-1303 (NCT03465722)) were continuing to receive avapritinib and were enrolled in this extension study.
Participant milestones
| Measure |
Avapritinib
Participants with gastrointestinal stromal tumor (GIST) who were deriving clinical benefit from avapritinib upon the completion of avapritinib clinical studies received avapritinib once daily (QD) at the specified dose of the prior avapritinib protocol.
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|---|---|
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Overall Study
STARTED
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2
|
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Overall Study
Received at Least 1 Dose of Study Drug
|
2
|
|
Overall Study
COMPLETED
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0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Avapritinib
Participants with gastrointestinal stromal tumor (GIST) who were deriving clinical benefit from avapritinib upon the completion of avapritinib clinical studies received avapritinib once daily (QD) at the specified dose of the prior avapritinib protocol.
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|---|---|
|
Overall Study
Commercial treatment became available
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1
|
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Overall Study
Disease progression
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1
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Baseline Characteristics
Study for Patients Previously Treated in Avapritinib Clinical Trials
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: From date of first avapritinib dose through 30 days after the last avapritinib dose (up to approximately 31 months)Population: The Safety Population was defined as all participants who received at least one dose of avapritinib.
AESIs for avapritinib are, regardless of grade or causality: * cognitive effects which include the following terms: memory impairment, cognitive disorder, confusional state and encephalopathy. * intracranial bleeding including haemorrhage intracranial, cerebral haemorrhage , and subdural haematoma.
Outcome measures
| Measure |
Avapritinib
n=2 Participants
Participants with GIST who were deriving clinical benefit from avapritinib upon the completion of avapritinib clinical studies received avapritinib QD at the specified dose of the prior avapritinib protocol.
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|---|---|
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Number of Participants With Adverse Events of Special Interest (AESIs)
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0 Participants
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PRIMARY outcome
Timeframe: From date of first avapritinib dose through 30 days after the last avapritinib dose (up to approximately 31 months)Population: The Safety Population was defined as all participants who received at least one dose of avapritinib.
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of all serious AEs, regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
Avapritinib
n=2 Participants
Participants with GIST who were deriving clinical benefit from avapritinib upon the completion of avapritinib clinical studies received avapritinib QD at the specified dose of the prior avapritinib protocol.
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|---|---|
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Number of Participants With Serious Adverse Events (SAEs)
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1 Participants
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Adverse Events
Avapritinib
Serious adverse events
| Measure |
Avapritinib
n=2 participants at risk
Participants with GIST who were deriving clinical benefit from avapritinib upon the completion of avapritinib clinical studies received avapritinib QD at the specified dose of the prior avapritinib protocol.
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|---|---|
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Gastrointestinal disorders
Gastrointestinal haemorrhage
|
50.0%
1/2 • Number of events 1 • From date of first avapritinib dose through 30 days after the last avapritinib dose (up to approximately 31 months)
The Safety Population was defined as all participants who received at least one dose of avapritinib. As specified in the protocol, only SAEs and AESIs were collected. Non-serious adverse event data was not collected.
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Musculoskeletal and connective tissue disorders
Arthralgia
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50.0%
1/2 • Number of events 1 • From date of first avapritinib dose through 30 days after the last avapritinib dose (up to approximately 31 months)
The Safety Population was defined as all participants who received at least one dose of avapritinib. As specified in the protocol, only SAEs and AESIs were collected. Non-serious adverse event data was not collected.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
1/2 • Number of events 2 • From date of first avapritinib dose through 30 days after the last avapritinib dose (up to approximately 31 months)
The Safety Population was defined as all participants who received at least one dose of avapritinib. As specified in the protocol, only SAEs and AESIs were collected. Non-serious adverse event data was not collected.
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|
Gastrointestinal disorders
Vomiting
|
50.0%
1/2 • Number of events 1 • From date of first avapritinib dose through 30 days after the last avapritinib dose (up to approximately 31 months)
The Safety Population was defined as all participants who received at least one dose of avapritinib. As specified in the protocol, only SAEs and AESIs were collected. Non-serious adverse event data was not collected.
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Other adverse events
Adverse event data not reported
Additional Information
Blueprint Medicines Medical Information
Blueprint Medicines
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER