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Completed

NCT Number: NCT06619275

Ripretinib (QINLOCK®) According to Current SmPC

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

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Key information

Conditions

GIST - Gastrointestinal Stromal Tumor Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Praxis für interdisziplinäre Onkologie und Hämatologie

Freiburg im Breisgau, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ripretinib

Drug

Switch-Control Tyrosine Kinase Inhibitor

Primary outcomes

  1. Evaluate Quality of Live (QoL): EQ-5D-5L index value

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

    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

  2. Evaluate Quality of Live (QoL): EQ-Visual Analogue Scale (VAS)

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

    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)

Secondary outcomes

  1. Subjective well-being: EQ-5D-5L questionnaire (index value)

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

    Time to deterioration (TTD) in the EQ-5D-5L index value

  2. Subjective well-being: EQ-5D-5L questionnaire (EQ-VAS)

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

    Time to deterioration (TTD) in the European Quality- Visual Analogue Scale (EQ-VAS)

  3. Assess effectiveness in routine treatment: Progression-free survival (PFS)

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

    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.

  4. Assess effectiveness in routine treatment: Overall Survival (OS)

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

    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.

  5. Assess effectiveness in routine treatment: Best response

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

    Best response is defined as Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD))

  6. Assess effectiveness in routine treatment: Overall Response Rate (ORR)

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

    ORR is defined as the proportion of patients achieving a complete or partial response as best response.

  7. Assess effectiveness in routine treatment: Disease Control Rate (DCR)

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

    DCR is defined as proportion of patients with Complete Response, Partial Response or Stable Disease as best response.

  8. Assess drug safety: Incidence of (serious) treatment emergent adverse events (TEAEs)

    Time frame: Baseline up to 30 days after ripretinib therapy

    An adverse event will be classified as TEAE if it is related to the study medication (ripretinib).

  9. Assess drug safety: Incidence of (serious) treatment emergent adverse drug reactions (TEADRs)

    Time frame: Baseline up to 30 days after ripretinib therapy

    An adverse drug reaction will be classified as TEADR if it is temporally related to the study medication (ripretinib).

  10. Assess parameters of physicians' treatment decision making using a questionnaire

    Time frame: Baseline

    Frequency of distinct parameters affecting therapy choice; questionnaire completed by treating physician.

  11. Line of ripretinib treatment

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

    Description of treatment reality in detail: Line of ripretinib treatment

  12. Absolute dose intensity

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

    Description of treatment reality in detail: Absolute dose intensity of ripretinib

  13. Relative dose intensity

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

    Description of treatment reality in detail: Relative dose intensity of ripretinib

  14. Frequency of dose modifications

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

    Description of treatment reality in detail: Frequency of dose modifications during ripretinib treatment

  15. Type of dose modifications

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

    Description of treatment reality in detail: Type of dose modifications during ripretinib treatment

  16. Reasons of dose modifications

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

    Description of treatment reality in detail: Reasons of dose modifications during ripretinib treatment

  17. Duration of treatment

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

    Description of treatment reality in detail: Duration of treatment with ripretinib

  18. Reasons for end of treatment (EOT)

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

    Description of treatment reality in detail: Reasons for EOT of treatment with ripretinib

  19. Previous local anticancer therapies per treatment setting

    Time frame: Baseline

    Description of treatment reality in detail: Frequency of previous local anticancer therapies per treatment setting

  20. Previous local anticancer therapies per treatment line

    Time frame: Baseline

    Description of treatment reality in detail: Frequency of previous local anticancer therapies per treatment line

  21. Previous systemic anticancer therapies per treatment setting

    Time frame: Baseline

    Description of treatment reality in detail: Frequency of previous systemic anticancer therapies per treatment setting

  22. Previous systemic anticancer therapies per treatment line

    Time frame: Baseline

    Description of treatment reality in detail: Frequency of previous systemic anticancer therapies per treatment line

  23. Concomitant local anticancer therapies

    Time frame: Baseline up to 30 days after ripretinib therapy

    Description of treatment reality in detail: Frequency of concomitant local anticancer therapies (i.e., surgeries and radiotherapies)

  24. Subsequent local anticancer therapies

    Time frame: From date of end of ripretinib treatment up to 36 months

    Description of treatment reality in detail: Frequency of subsequent local anticancer therapies

Sponsors and collaborators

Lead sponsor

iOMEDICO AG

Industry

Collaborators

  • Deciphera Pharmaceuticals (Switzerland) AG

Registry information

Official study title

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

Acronym: INTEREST

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 1, 2024
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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