Clinical trial NCT06619275: Ripretinib (QINLOCK®) According to Current SmPC
Official title: Ripretinib in Patients With Previously Treated Advanced Gastrointestinal Stromal Tumor (GIST): a Prospective, Longitudinal, Multicenter, Observational Study in Germany
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: GIST - Gastrointestinal Stromal Tumor
Keywords: advanced
Lead sponsor: iOMEDICO AG
Sponsor class: INDUSTRY
Collaborators: name: Deciphera Pharmaceuticals (Switzerland) AG
First posted: 2024-10-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients diagnosed with advanced GIST who received 3 or more tyrosine kinase inhibitors (including imatinib).

Brief 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\&#39; treatment decision making
* Description of treatment reality in detail


Eligibility 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.

Primary outcomes:
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)
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)
Secondary outcomes:
measure: Subjective well-being: EQ-5D-5L questionnaire (index value)
timeFrame: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
measure: Subjective well-being: EQ-5D-5L questionnaire (EQ-VAS)
timeFrame: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
measure: Assess effectiveness in routine treatment: Progression-free survival (PFS)
timeFrame: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
measure: Assess effectiveness in routine treatment: Overall Survival (OS)
timeFrame: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
measure: Assess effectiveness in routine treatment: Best response
timeFrame: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
measure: Assess effectiveness in routine treatment: Overall Response Rate (ORR)
timeFrame: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
measure: Assess effectiveness in routine treatment: Disease Control Rate (DCR)
timeFrame: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
measure: Assess drug safety: Incidence of (serious) treatment emergent adverse events (TEAEs)
timeFrame: Baseline up to 30 days after ripretinib therapy
measure: Assess drug safety: Incidence of (serious) treatment emergent adverse drug reactions (TEADRs)
timeFrame: Baseline up to 30 days after ripretinib therapy
measure: Assess parameters of physicians' treatment decision making using a questionnaire
timeFrame: Baseline
measure: Line of ripretinib treatment
timeFrame: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
measure: Absolute dose intensity
timeFrame: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
measure: Relative dose intensity
timeFrame: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
measure: Frequency of dose modifications
timeFrame: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
measure: Type of dose modifications
timeFrame: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
measure: Reasons of dose modifications
timeFrame: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
measure: Duration of treatment
timeFrame: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
measure: Reasons for end of treatment (EOT)
timeFrame: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
measure: Previous local anticancer therapies per treatment setting
timeFrame: Baseline
measure: Previous local anticancer therapies per treatment line
timeFrame: Baseline
measure: Previous systemic anticancer therapies per treatment setting
timeFrame: Baseline
measure: Previous systemic anticancer therapies per treatment line
timeFrame: Baseline
measure: Concomitant local anticancer therapies
timeFrame: Baseline up to 30 days after ripretinib therapy
measure: Subsequent local anticancer therapies
timeFrame: From date of end of ripretinib treatment up to 36 months
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Praxis für interdisziplinäre Onkologie und Hämatologie
Study officials:
References: