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This is an open-label extension study to provide long term safety data for GIST patients who are deriving clinical benefit from avapritinib upon the completion of avapritinib clinical trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with GIST previously enrolled in avapritinib clinical trials | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avapritinib | Drug | avapritinib tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events of Special Interest (AESIs) | AESIs for avapritinib are, regardless of grade or causality:
| From date of first avapritinib dose through 30 days after the last avapritinib dose (up to approximately 31 months) |
| Number of Participants With Serious Adverse Events (SAEs) | 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. | From date of first avapritinib dose through 30 days after the last avapritinib dose (up to approximately 31 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gustave Roussy Cancer Campus Grand Paris Institut de Cancerologie Gustave-Roussy | Villejuif | Val-de-Marne | 94800 | France |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
The Safety Population was defined as all participants who received at least one dose of avapritinib. Baseline measure data are not reported for participant privacy reasons due to low enrollment
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| ID | Title | Description |
|---|---|---|
| BG000 | Avapritinib | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | The Safety Population was defined as all participants who received at least one dose of avapritinib. Baseline measure data are not reported for participant privacy reasons due to low enrollment |
| 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 | Number of Participants With Adverse Events of Special Interest (AESIs) | AESIs for avapritinib are, regardless of grade or causality:
| The Safety Population was defined as all participants who received at least one dose of avapritinib. | Posted | Count of Participants | Participants | From date of first avapritinib dose through 30 days after the last avapritinib dose (up to approximately 31 months) |
|
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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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Avapritinib | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Blueprint Medicines Medical Information | Blueprint Medicines | 1-888-258-7768 | medinfo@blueprintmedicines.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 7, 2021 | Oct 31, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D046152 | Gastrointestinal Stromal Tumors |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000707147 | avapritinib |
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| Count of Participants |
| Participants |
|
| Sex: Female, Male | The Safety Population was defined as all participants who received at least one dose of avapritinib. Baseline measure data are not reported for participant privacy reasons due to low enrollment | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | The Safety Population was defined as all participants who received at least one dose of avapritinib. Baseline measure data are not reported for participant privacy reasons due to low enrollment | Count of Participants | Participants |
|
| Race (NIH/OMB) | The Safety Population was defined as all participants who received at least one dose of avapritinib. Baseline measure data are not reported for participant privacy reasons due to low enrollment | Count of Participants | Participants |
|
|
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| Primary | Number of Participants With Serious Adverse Events (SAEs) | 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. | The Safety Population was defined as all participants who received at least one dose of avapritinib. | Posted | Count of Participants | Participants | From date of first avapritinib dose through 30 days after the last avapritinib dose (up to approximately 31 months) |
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| 0 |
| 2 |
| 1 |
| 2 |
| 0 |
| 0 |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA v24.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA v24.0 | Systematic Assessment |
|
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| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |