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

Launched by XINHUA ZHANG, MD · Jul 15, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Avapritinib to see how well it works for patients with a type of cancer known as gastrointestinal stromal tumors (GIST) that cannot be surgically removed or have come back after treatment. Specifically, the trial focuses on patients with certain genetic changes in the PDGFRA gene, which are not related to a specific mutation called exon 18. The study is currently recruiting participants aged 18 and older who have been diagnosed with GIST and have measurable tumors.

To be eligible, participants need to have confirmed GIST, be in fairly good health (meaning they can perform daily activities), and be willing to sign consent forms and attend follow-up appointments. Those who have different types of genetic changes, certain health issues, or who can't tolerate previous treatments may not be able to join. Participants in this trial will receive Avapritinib and will be monitored to see how well the treatment works and what effects it has. This is an important study that could help improve treatment options for people with this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients who are aged ≥ 18 years.
• • Gastrointestinal stromal tumors confirmed by histopathological examination, and CD- and/or DOG-1-positive by immunohistochemistry.
• • Presence of mRECIST v1.1-compliant lesions with at least one measurable lesion (non-lymphadenopathy ≥1.0 cm or ≥2-fold scan slice thickness).
• • Treatment with Avapritinib.
• • Patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2 at screening.
• • Patient informed consent and signed written consent form.
• • The patient was compliant and voluntarily scheduled for follow-up, treatment, laboratory tests, and other study procedures.
• Exclusion Criteria:
• • KIT or PDGFRA wild type.
• • Failure to complete continuous atorvastatin for at least 15 days due to intolerability or disease progression.
• • Other serious acute or chronic physical or mental problems, or laboratory abnormalities, may increase the risk associated with participation in the study or use of drugs, or interfere with the judgment of the study results and, in the judgment of the investigator, are not considered appropriate for participation in the investigator.