Study for Patients Previously Treated in Avapritinib Clinical Trials

Gastrointestinal Stromal Tumors Clinical Trial

Official title:

Extension Protocol for Patients Previously Treated in Avapritinib Clinical Trials

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04825574
• Other study ID #: BLU-285-1408
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: May 21, 2021
• Est. completion date: August 1, 2025

Study information

• Verified date: August 2023
• Source: Blueprint Medicines Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors

Intervention

Drug:
• Avapritinib
avapritinib tablet

Locations

Country	Name	City	State
France	Gustave Roussy Cancer Campus Grand Paris Institut de Cancerologie Gustave-Roussy	Villejuif	Val-de-Marne

Sponsors (1)

Lead Sponsor	Collaborator
Blueprint Medicines Corporation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety as assessed by the number of serious adverse events and adverse events of special interest		up to 2 years