The Correlation Between Ripretinib Exposure and the Efficacy and Safety in Patients with Advanced GISTs

Launched by FIRST AFFILIATED HOSPITAL, SUN YAT-SEN UNIVERSITY · May 27, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on understanding how exposure to a medication called ripretinib affects its effectiveness and safety in treating advanced gastrointestinal stromal tumors (GISTs). GISTs are a type of cancer found in the digestive system. The study is currently looking for participants who are at least 18 years old, have been diagnosed with GISTs, and are already receiving ripretinib treatment. To join the study, participants must have at least one measurable tumor and be able to attend follow-up appointments for tests and treatments.

If you or a loved one is eligible and decides to participate, you'll help researchers gather important information about how ripretinib works for patients with advanced GISTs. The study will monitor your health and side effects while you continue your treatment. This research is important because it can help improve future treatments for others facing similar diagnoses. Please note that those with certain health issues or who can't tolerate the medication may not be able to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients who are aged ≥ 18 years.
• • Gastrointestinal stromal tumors confirmed by histopathological examination, and CD117 and/or DOG-1-positive by immunohistochemistry.
• • patients who are currently receiving Ripretinib treatment.
• • Subjects must have at least one measurable lesion based on mRECIST v1.1 criteria, and have undergone at least one radiographic evaluation for efficacy analysis.
• • Patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 4
• • 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:
• • Unable to complete at least 15 consecutive days of Ripretinib due to intolerance or disease progression.
• • Individuals with other serious acute or chronic physical or mental health problems, or abnormal laboratory test results that increase the risk associated with participation in the study or use of the drug, or that could interfere with the interpretation of study results, and who, in the opinion of the investigator, are not suitable for participation in the study.