Study for Patients Previously Treated in Avapritinib Clinical Trials

NCT ID: NCT04825574

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-21
• Study Completion Date: 2023-11-23

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.

Conditions

Gastrointestinal Stromal Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with GIST previously enrolled in avapritinib clinical trials

Group Type: EXPERIMENTAL

Avapritinib

Intervention Type: DRUG

avapritinib tablet

Interventions

Avapritinib

avapritinib tablet

Intervention Type: DRUG

Other Intervention Names

BLU-285

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Blueprint Medicines Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gustave Roussy Cancer Campus Grand Paris Institut de Cancerologie Gustave-Roussy

Villejuif, Val-de-Marne, France

Countries

France

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

BLU-285-1408

Identifier Type: -

Identifier Source: org_study_id