Study for Patients Previously Treated in Avapritinib Clinical Trials

Sponsor
Blueprint Medicines Corporation (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04825574
Collaborator
(none)
5
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
5 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Extension Protocol for Patients Previously Treated in Avapritinib Clinical Trials
Actual Study Start Date :
May 21, 2021
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients with GIST previously enrolled in avapritinib clinical trials

Drug: Avapritinib
avapritinib tablet
Other Names:
  • BLU-285
  • Outcome Measures

    Primary Outcome Measures

    1. Safety as assessed by the number of serious adverse events and adverse events of special interest [up to 2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. 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.

    2. Patient continues to receive clinical benefit from avapritinib treatment, as assessed by the investigator.

    3. Patient or legal guardian, if permitted by local regulatory authorities, provides informed consent.

    Exclusion Criteria:
    1. Patient requires therapy with a concomitant medication that is a strong inhibitor or strong inducer of cytochrome P450 (CYP) 3A4

    2. Patient has a history of intracranial bleeding either prior to or during avapritinib treatment

    3. 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.

    4. 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.

    5. 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.

    6. Women who are pregnant.

    7. Women who are breast feeding.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gustave Roussy Cancer Campus Grand Paris Institut de Cancerologie Gustave-Roussy Villejuif Val-de-Marne France 94800

    Sponsors and Collaborators

    • Blueprint Medicines Corporation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Blueprint Medicines Corporation
    ClinicalTrials.gov Identifier:
    NCT04825574
    Other Study ID Numbers:
    • BLU-285-1408
    First Posted:
    Apr 1, 2021
    Last Update Posted:
    May 18, 2022
    Last Verified:
    Apr 1, 2022
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 18, 2022