Study for Patients Previously Treated in Avapritinib Clinical Trials
Primary Purpose
Gastrointestinal Stromal Tumors
Status
Active
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Avapritinib
Sponsored by
About this trial
This is an interventional treatment trial for Gastrointestinal Stromal Tumors
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Gustave Roussy Cancer Campus Grand Paris Institut de Cancerologie Gustave-Roussy
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with GIST previously enrolled in avapritinib clinical trials
Arm Description
Outcomes
Primary Outcome Measures
Safety as assessed by the number of serious adverse events and adverse events of special interest
Secondary Outcome Measures
Full Information
NCT ID
NCT04825574
First Posted
March 29, 2021
Last Updated
August 1, 2023
Sponsor
Blueprint Medicines Corporation
1. Study Identification
Unique Protocol Identification Number
NCT04825574
Brief Title
Study for Patients Previously Treated in Avapritinib Clinical Trials
Official Title
Extension Protocol for Patients Previously Treated in Avapritinib Clinical Trials
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 21, 2021 (Actual)
Primary Completion Date
August 1, 2025 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Blueprint Medicines Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Stromal Tumors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with GIST previously enrolled in avapritinib clinical trials
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Avapritinib
Other Intervention Name(s)
BLU-285
Intervention Description
avapritinib tablet
Primary Outcome Measure Information:
Title
Safety as assessed by the number of serious adverse events and adverse events of special interest
Time Frame
up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Gustave Roussy Cancer Campus Grand Paris Institut de Cancerologie Gustave-Roussy
City
Villejuif
State/Province
Val-de-Marne
ZIP/Postal Code
94800
Country
France
12. IPD Sharing Statement
Learn more about this trial
Study for Patients Previously Treated in Avapritinib Clinical Trials
We'll reach out to this number within 24 hrs