Actively Recruiting

Age: 18Years +
All Genders
ID05461664

Avapritinib in the Treatment of Unresectable or Recurrent Metastatic Gastrointestinal Stromal Tumors Non-exon18 Mutations of PDGFRA A Real-world Study

Led by Xinhua Zhang, MD · Updated on 2025-02-26

74

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

X

Xinhua Zhang, MD

Lead Sponsor

P

Peking University Cancer Hospital & Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are exploring the use of Avapritinib therapy in patients with gastrointestinal stromal tumors (GIST) that have non-exon18 mutations of the PDGFRA gene. GISTs are common tumors in the gastrointestinal tract that vary from benign to malignant and often involve mutations in the KIT or PDGFRA genes. This study aims to understand the benefits of Avapritinib beyond the PDGFRA exon18 mutation and to investigate resistance mutations that affect treatment outcomes in advanced GISTs. This is a prospective, multicenter, observational real-world study focusing on patients with unresectable or recurrent metastatic GIST who have non-exon18 PDGFRA mutations and are treated with Avapritinib. Participants receive Avapritinib therapy as part of their routine care, and the study observes their responses and mutation changes over time. The study does not involve randomization or placebo groups but monitors participants under real-world conditions. Participants will undergo regular follow-up visits for clinical evaluation, imaging tests compliant with mRECIST v1.1 criteria, laboratory assessments, and recording of adverse events over two years. Researchers will measure outcomes such as objective response rate, clinical benefit rate, duration of response, progression-free survival, overall survival, and treatment-related safety events. The study emphasizes ongoing monitoring to provide evidence for personalized treatment approaches in advanced GIST patients.

CONDITIONS

Brief Title

Avapritinib in the Treatment of Unresectable or Recurrent Metastatic GIST Non-exon18 Mutations of PDGFRA

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who are aged 65 18 years.
  • Confirmed diagnosis of gastrointestinal stromal tumors by histopathological examination.
  • Positive immunohistochemistry for CD-117 and/or DOG-1.
  • Presence of at least one measurable lesion according to mRECIST v1.1.
  • Currently receiving treatment with Avapritinib.
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2 at screening.
  • Patient provides informed consent and agrees to follow-up, treatment, and study procedures.
Not Eligible

You will not qualify if you...

  • KIT or PDGFRA wild type tumors.
  • Inability to complete continuous Avapritinib treatment for at least 15 days due to intolerance or disease progression.
  • Presence of serious acute or chronic physical or mental conditions, or laboratory abnormalities that increase risk or interfere with study participation or results, as judged by the investigator.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 2 years

Participants who are currently receiving Avapritinib treatment are observed to assess the effectiveness and safety of the medication.

Regular visits to monitor treatment response and adverse events

Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, China, 510080

Actively Recruiting

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Research Team

X

Xinhua Zhang, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Kinase mutations and imatinib response in patients with metastatic gastrointestinal stromal tumor.

Michael C Heinrich, Christopher L Corless, George D Demetri...

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Robust Activity of Avapritinib, Potent and Highly Selective Inhibitor of Mutated KIT, in Patient-derived Xenograft Models of Gastrointestinal Stromal Tumors.

Yemarshet K Gebreyohannes, Agnieszka Wozniak, Madalina-Elena Zhai...

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Avapritinib in advanced PDGFRA D842V-mutant gastrointestinal stromal tumour (NAVIGATOR): a multicentre, open-label, phase 1 trial.

Michael C Heinrich, Robin L Jones, Margaret von Mehren...

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Avapritinib in unresectable or metastatic PDGFRA D842V-mutant gastrointestinal stromal tumours: Long-term efficacy and safety data from the NAVIGATOR phase I trial.

Robin L Jones, César Serrano, Margaret von Mehren...

https://pubmed.ncbi.nlm.nih.gov/33465704