Ripretinib (QINLOCK®) According to Current SmPC

NCT06619275 | Completed

• 1 other identifier: iOM-120455
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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\' treatment decision making
• Description of treatment reality in detail

Conditions

GIST - Gastrointestinal Stromal Tumor

Keywords

advanced

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (24)

• Subjective well-being: EQ-5D-5L questionnaire (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)

  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)

  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)

  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

  max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)

Interventions

Ripretinib DRUG

Switch-Control Tyrosine Kinase Inhibitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• iOMEDICO AG: lead
• Deciphera Pharmaceuticals (Switzerland) AG: collaborator

Study Sites (1)

Praxis für interdisziplinäre Onkologie und Hämatologie

Freiburg im Breisgau, Germany

Location

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

ripretinib

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: October 17, 2024
• Primary Completion: August 15, 2025
• Study Completion: September 15, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)