Clinical trial · Observational
Ripretinib (QINLOCK®) According to Current SmPC
Ripretinib in Patients With Previously Treated Advanced Gastrointestinal Stromal Tumor (GIST): a Prospective, Longitudinal, Multicenter, Observational Study in Germany
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| GIST - Gastrointestinal Stromal Tumor | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ripretinib | Drug | Ripretinib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- 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)
- description
- Evaluation of Quality of Life by validated European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) questionnaire. Change from baseline in the EQ-5D-5L index value
- measure
- 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)
- description
- Evaluation of Quality of Life by validated European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) questionnaire. Change from baseline in the EQ-Visual Analogue Scale (VAS)
Secondary outcomes (24)
- measure
- Subjective well-being: EQ-5D-5L questionnaire (index value)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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