Collecting real-world data on ripretinib treatment for advanced GIST patients in Germany
Ripretinib in Patients With Previously Treated Advanced Gastrointestinal Stromal Tumor (GIST): a Prospective, Longitudinal, Multicenter, Observational Study in Germany
This study is trying to see how well ripretinib works and affects the quality of life for people with advanced GIST in Germany.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | iOMEDICO AG Industry-sponsored |
| Drugs / interventions | imatinib, ripretinib |
| Locations | 1 site (Freiburg) |
| Trial ID | NCT06619275 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather real-world data on the treatment of advanced gastrointestinal stromal tumors (GIST) with ripretinib in Germany. It will evaluate the quality of life of patients using the EQ-5D-5L questionnaire, assess treatment effectiveness through various survival and response metrics, and analyze drug safety. Additionally, the study will provide insights into physicians' treatment decision-making and the overall treatment landscape for GIST patients. The data collected will help understand the impact of ripretinib on patient well-being and treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed advanced GIST who have previously received treatment with three or more kinase inhibitors.
Not a fit: Patients who are unable to consent or those currently participating in another interventional clinical trial may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of ripretinib's effectiveness and safety, ultimately improving treatment strategies for GIST patients.
How similar studies have performed: While this study is focused on real-world data collection, similar observational studies have shown success in evaluating treatment outcomes in various cancer therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patient is eligible if all criteria are met: * Aged 18 years or older. * Histologically confirmed advanced GIST. * Patients must have received prior treatment with three or more kinase inhibitors, including imatinib. * Decision for treatment with ripretinib as per current SmPC. * Signed written informed consent \* Patients are allowed to be enrolled up to 6 weeks after their first dose of ripretinib. Patients with signed written informed consent after start of ripretinib treatment are not participating in the PRO assessments. * Willingness and capability to participate in Patient-Reported Outcome (PRO) assessment in German language. * Other criteria according to current SmPC. Exclusion Criteria: * Participation in an interventional clinical trial within 30 days prior to enrolment or simultaneous participation in an interventional clinical trial except for the follow-up period. * Patients unable to consent. * Other contraindications according to current SmPC.
Where this trial is running
Freiburg
- Praxis für interdisziplinäre Onkologie und Hämatologie — Freiburg, Germany (Recruiting)
Study contacts
- Study coordinator: iOMEDICO
- Email: information@iomedico.com
- Phone: +49761152420
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.