Study for Patients Previously Treated in Avapritinib Clinical Trials

NCT04825574 | Completed Phase 4 Results FDA Drug

• 1 other identifier: BLU-285-1408
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From date of first avapritinib dose through 30 days after the last avapritinib dose (up to approximately 31 months)

Study Arms (1)

Patients with GIST previously enrolled in avapritinib clinical trials

EXPERIMENTAL

Drug: Avapritinib

Interventions

Avapritinib DRUG

avapritinib tablet

Also known as: BLU-285

Patients with GIST previously enrolled in avapritinib clinical trials

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Blueprint Medicines Corporation: lead

Study Sites (1)

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

Villejuif, Val-de-Marne, 94800, France

Location

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

avapritinib

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Results Point of Contact

• Title: Blueprint Medicines Medical Information
• Organization: Blueprint Medicines

medinfo@blueprintmedicines.com

1-888-258-7768

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 1, 2021
• Study Start: May 21, 2021
• Primary Completion: November 23, 2023
• Study Completion: November 23, 2023
• Last Updated: November 26, 2024
• Results First Posted: November 26, 2024

Record last verified: 2024-10

Locations

FR (1)