Gastrointestinal Stromal TumorsPhase 4NCT04825574
Study for Patients Previously Treated in Avapritinib Clinical Trials
A Phase 4 study testing Avapritinib in people with Gastrointestinal Stromal Tumors, run by Blueprint Medicines Corporation at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Stromal Tumors
- What is being tested?
- Avapritinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 21 May 2021to 23 Nov 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has histologically confirmed metastatic or unresectable GIST as established by entry in a previous avapritinib clinical trial and has been receiving treatment with avapritinib on one of these trials.
- Patient continues to receive clinical benefit from avapritinib treatment, as assessed by the investigator.
- Patient or legal guardian, if permitted by local regulatory authorities, provides informed consent.
Who cannot join
- Patient requires therapy with a concomitant medication that is a strong inhibitor or strong inducer of cytochrome P450 (CYP) 3A4
- Patient has a history of intracranial bleeding either prior to or during avapritinib treatment
- Patients who have poor organ function, defined as Adverse Events of NCI CTCAE version 5.0 Grade 3 or higher at the time of enrollment must delay start of treatment until symptoms return to Grade 2 or baseline, or the start of treatment has been approved by the Sponsor.
- Patients who have ongoing cognitive or mood effects Adverse Events of NCI CTCAE version 5.0 higher than Grade 1 must delay start of treatment until symptoms return to Grade 1 or baseline.
- Women who are unwilling, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of enrollment and for at least 30 days after the last dose of avapritinib. Men who are unwilling, if not surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of first dose and for at least 90 days after the last dose of avapritinib.
- Women who are pregnant.
- Women who are breast feeding.
Trial locations and contacts
1 site in 1 country.
France1 site
Gustave Roussy Cancer Campus Grand Paris Institut de Cancerologie Gustave-Roussy
Villejuif, Val-de-Marne, 94800
About this study
Official title: Extension Protocol for Patients Previously Treated in Avapritinib Clinical Trials
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.
- Conditions
- Gastrointestinal Stromal Tumors
- Being tested
- Avapritinib
- Medical subject headings
- Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvapritinibDrug
Also called BLU-285
avapritinib tablet
| Study group | Role | What they receive |
|---|---|---|
| Patients with GIST previously enrolled in avapritinib clinical trials | Experimental | Not described Receives: Drug: Avapritinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events of Special Interest (AESIs)
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.
Measured: 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.
Measured: From date of first avapritinib dose through 30 days after the last avapritinib dose (up to approximately 31 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start21 May 2021
- Primary completion23 Nov 2023
- Study completion23 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastrointestinal Stromal TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blueprint Medicines Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825574
- Sponsor's protocol ID
- BLU-285-1408
- Status last verified
- Oct 2024
- First submitted
- 29 Mar 2021
- Last updated
- 26 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extension Protocol for Patients Previously Treated in Avapritinib Clinical Trials
- ClinicalTrials.gov ID
- NCT04825574
- Acronym / sponsor ID
- BLU-285-1408
- Conditions
- Gastrointestinal Stromal Tumors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Blueprint Medicines CorporationIndustry (pharma, biotech, devices)
- Study start
- 21 May 2021 (actual)
- Primary completion
- 23 Nov 2023 (actual)
- Study completion
- 23 Nov 2023 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Posted 26 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with GIST previously enrolled in avapritinib clinical trials | Experimental | Drug: Avapritinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient has histologically confirmed metastatic or unresectable GIST as established by entry in a previous avapritinib clinical trial and has been receiving treatment with avapritinib on one of these trials.
- Patient continues to receive clinical benefit from avapritinib treatment, as assessed by the investigator.
- Patient or legal guardian, if permitted by local regulatory authorities, provides informed consent.
Key exclusion criteria (7 listed)
- Patient requires therapy with a concomitant medication that is a strong inhibitor or strong inducer of cytochrome P450 (CYP) 3A4
- Patient has a history of intracranial bleeding either prior to or during avapritinib treatment
- Patients who have poor organ function, defined as Adverse Events of NCI CTCAE version 5.0 Grade 3 or higher at the time of enrollment must delay start of treatment until symptoms return to Grade 2 or baseline, or the start of treatment has been approved by the Sponsor.
- Patients who have ongoing cognitive or mood effects Adverse Events of NCI CTCAE version 5.0 higher than Grade 1 must delay start of treatment until symptoms return to Grade 1 or baseline.
- Women who are unwilling, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of enrollment and for at least 30 days after the last dose of avapritinib. Men who are unwilling, if not surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of first dose and for at least 90 days after the last dose of avapritinib.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvapritinibAlso: BLU-285avapritinib tablet | Drug | Patients with GIST previously enrolled in avapritinib clinical trials |
Primary outcome
Number of Participants With Adverse Events of Special Interest (AESIs)
Time frame: From date of first avapritinib dose through 30 days after the last avapritinib dose (up to approximately 31 months)
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.
Number of Participants With Serious Adverse Events (SAEs)
Time frame: From date of first avapritinib dose through 30 days after the last avapritinib dose (up to approximately 31 months)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Avapritinib in people with Gastrointestinal Stromal Tumors, run by Blueprint Medicines Corporation at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events of Special Interest (AESIs) (time frame: From date of first avapritinib dose through 30 days after the last avapritinib dose (up to approximately 31 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.