Examining how ripretinib affects patients with advanced gastrointestinal stromal tumors
The Correlation Between Ripretinib Exposure and the Efficacy and Safety in Patients with Advanced Gastrointestinal Stromal Tumors: an Observational Study
This study is testing how well ripretinib works and how safe it is for adults with advanced gastrointestinal stromal tumors who are already taking the medication.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | First Affiliated Hospital, Sun Yat-Sen University Academic / other |
| Drugs / interventions | Ripretinib, imatinib, sunitinib |
| Locations | 1 site (Guangzhou) |
| Trial ID | NCT06431451 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the relationship between ripretinib exposure and its efficacy and safety in patients suffering from advanced gastrointestinal stromal tumors (GISTs). It involves patients aged 18 and older who are currently receiving ripretinib treatment and have measurable lesions. The study will assess the drug's impact on disease progression and patient tolerability, building on previous findings that suggest ripretinib has a favorable safety profile compared to other treatments. The research will be conducted at a single center, focusing on the correlation between plasma drug concentration and clinical outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with confirmed advanced gastrointestinal stromal tumors who are currently being treated with ripretinib.
Not a fit: Patients who are unable to tolerate ripretinib for at least 15 consecutive days or have other serious health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of ripretinib's effectiveness and safety, potentially leading to improved treatment strategies for patients with advanced GISTs.
How similar studies have performed: Previous studies have shown promising results with ripretinib in treating advanced GISTs, indicating that this approach is based on established findings.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou
- The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, China (Recruiting)
Study contacts
- Study coordinator: xinhua zhang, MD
- Email: zhangxinhua@mail.sysu.edu.cn
- Phone: +8613828463644
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.