Ripretinib (QINLOCK®) According to Current SmPC (NCT06619275) | Clinical Trial Compass
CompletedNot Applicable
Ripretinib (QINLOCK®) According to Current SmPC
Germany10 participantsStarted 2024-10-17
Plain-language summary
The goal of this prospective, observational study INTEREST is to collect real-world data on ripretinib treatment in a broad patient population in Germany. Ripretinib will be administered according to the current SmPC. Thus, INTEREST will evaluate for the first time ripretinib in GIST patients in a real-world setting in Germany.
The main questions the study aims to answer are:
* Evaluate quality of live (QoL) using the questionnaire EQ-5D-5L to gain knowledge about how ripretinib treatment affects GIST patients' well-being (change compared to Baseline, Time to Deterioration)
* Assessment of effectiveness in routine treatment (Progression-Free Survival, Overall Survival, Best Response, Overall Response Rate, Disease Control Rate
* Assessment of drug safety
* Assessment of parameters of physicians\' treatment decision making
* Description of treatment reality in detail
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate Quality of Live (QoL): EQ-5D-5L index value
Timeframe: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
2
Evaluate Quality of Live (QoL): EQ-Visual Analogue Scale (VAS)
Timeframe: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)