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

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

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

Study Overview

• Status: Completed
• Conditions: GIST - Gastrointestinal Stromal Tumor
• Intervention / Treatment: Drug: Ripretinib

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Germany
  • Freiburg im Breisgau, Germany
    • Praxis für interdisziplinäre Onkologie und Hämatologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with advanced GIST who received 3 or more tyrosine kinase inhibitors (including imatinib).

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate Quality of Live (QoL): EQ-5D-5L index value	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	max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Evaluate Quality of Live (QoL): EQ-Visual Analogue Scale (VAS)	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)	max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective well-being: EQ-5D-5L questionnaire (index value)	Time to deterioration (TTD) in the EQ-5D-5L index value	max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Subjective well-being: EQ-5D-5L questionnaire (EQ-VAS)	Time to deterioration (TTD) in the European Quality- Visual Analogue Scale (EQ-VAS)	max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Assess effectiveness in routine treatment: Progression-free survival (PFS)	PFS is defined as time interval measured form the day of first ripretinib administration to first progression or death, whichever comes first. Patients without tumor progression or death at the time of analysis will be censored at their date of last contact.	max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Assess effectiveness in routine treatment: Overall Survival (OS)	OS is defined as the time interval measured form the day of first ripretinib administration to time of death from any cause. Time to last contact will be used if a patient has no documented date of death and OS for the patient will be considered censored.	max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Assess effectiveness in routine treatment: Best response	Best response is defined as Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD))	max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Assess effectiveness in routine treatment: Overall Response Rate (ORR)	ORR is defined as the proportion of patients achieving a complete or partial response as best response.	max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Assess effectiveness in routine treatment: Disease Control Rate (DCR)	DCR is defined as proportion of patients with Complete Response, Partial Response or Stable Disease as best response.	max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Assess drug safety: Incidence of (serious) treatment emergent adverse events (TEAEs)	An adverse event will be classified as TEAE if it is related to the study medication (ripretinib).	Baseline up to 30 days after ripretinib therapy
Assess drug safety: Incidence of (serious) treatment emergent adverse drug reactions (TEADRs)	An adverse drug reaction will be classified as TEADR if it is temporally related to the study medication (ripretinib).	Baseline up to 30 days after ripretinib therapy
Line of ripretinib treatment	Description of treatment reality in detail: Line of ripretinib treatment	max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Absolute dose intensity	Description of treatment reality in detail: Absolute dose intensity of ripretinib	max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Relative dose intensity	Description of treatment reality in detail: Relative dose intensity of ripretinib	max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Frequency of dose modifications	Description of treatment reality in detail: Frequency of dose modifications during ripretinib treatment	max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Type of dose modifications	Description of treatment reality in detail: Type of dose modifications during ripretinib treatment	max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Reasons of dose modifications	Description of treatment reality in detail: Reasons of dose modifications during ripretinib treatment	max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Duration of treatment	Description of treatment reality in detail: Duration of treatment with ripretinib	max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Reasons for end of treatment (EOT)	Description of treatment reality in detail: Reasons for EOT of treatment with ripretinib	max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Previous local anticancer therapies per treatment setting	Description of treatment reality in detail: Frequency of previous local anticancer therapies per treatment setting	Baseline
Previous local anticancer therapies per treatment line	Description of treatment reality in detail: Frequency of previous local anticancer therapies per treatment line	Baseline
Previous systemic anticancer therapies per treatment setting	Description of treatment reality in detail: Frequency of previous systemic anticancer therapies per treatment setting	Baseline
Previous systemic anticancer therapies per treatment line	Description of treatment reality in detail: Frequency of previous systemic anticancer therapies per treatment line	Baseline
Concomitant local anticancer therapies	Description of treatment reality in detail: Frequency of concomitant local anticancer therapies (i.e., surgeries and radiotherapies)	Baseline up to 30 days after ripretinib therapy
Subsequent local anticancer therapies	Description of treatment reality in detail: Frequency of subsequent local anticancer therapies	From date of end of ripretinib treatment up to 36 months
Assess parameters of physicians' treatment decision making using a questionnaire	Frequency of distinct parameters affecting therapy choice; questionnaire completed by treating physician.	Baseline

Collaborators and Investigators

• Sponsor: iOMEDICO AG
• Collaborators: Deciphera Pharmaceuticals (Switzerland) AG

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2024
• Primary Completion (Actual): August 15, 2025
• Study Completion (Actual): September 15, 2025

Study Registration Dates

• First Submitted: September 26, 2024
• First Submitted That Met QC Criteria: September 26, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: advanced
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms, Connective Tissue; Gastrointestinal Stromal Tumors; ripretinib
• Other Study ID Numbers: iOM-120455

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No