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Completed

NCT Number: NCT04825574

Study for Patients Previously Treated in Avapritinib Clinical Trials

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Villejuif, Val-de-Marne, 94800, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Avapritinib

Drug

avapritinib tablet

Other names: BLU-285

Primary outcomes

  1. Number of Participants With Adverse Events of Special Interest (AESIs)

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

    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.

  2. Number of Participants With Serious Adverse Events (SAEs)

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

    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.

Sponsors and collaborators

Lead sponsor

Blueprint Medicines Corporation

Industry

Registry information

Official study title

Extension Protocol for Patients Previously Treated in Avapritinib Clinical Trials

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 1, 2021
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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