Ripretinib (QINLOCK®) According to Current SmPC (INTEREST)

iOMEDICO

Status: Completed

Conditions: GIST - Gastrointestinal Stromal Tumor

Treatments: Drug: Ripretinib

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT06619275

iOM-120455

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.