Ripretinib in Patients With Previously Treated Advanced Gastrointestinal Stromal Tumor (GIST): a Prospective, Longitudinal, Multicenter, Observational Study in Germany

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
Germany
Praxis für interdisziplinäre Onkologie und Hämatologie
RECRUITING
Freiburg Im Breisgau
Contact Information
Primary
iOMEDICO
information@iomedico.com
+49761152420
Time Frame
Start Date: 2024-10-17
Estimated Completion Date: 2027-11
Participants
Target number of participants: 100
Related Therapeutic Areas
Sponsors
Leads: iOMEDICO AG
Collaborators: Deciphera Pharmaceuticals (Switzerland) AG

This content was sourced from clinicaltrials.gov