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 Type
OBSERVATIONAL
Enrollment
10
Switch-Control Tyrosine Kinase Inhibitor
Praxis für interdisziplinäre Onkologie und Hämatologie
Freiburg im Breisgau, Germany
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
Time frame: 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)
Time frame: 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 (index value)
Time to deterioration (TTD) in the 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)
Subjective well-being: EQ-5D-5L questionnaire (EQ-VAS)
Time to deterioration (TTD) in the European Quality- Visual Analogue Scale (EQ-VAS)
Time frame: 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.
Time frame: 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.
Time frame: 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))
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: Baseline up to 30 days after ripretinib therapy
Assess parameters of physicians' treatment decision making using a questionnaire
Frequency of distinct parameters affecting therapy choice; questionnaire completed by treating physician.
Time frame: Baseline
Line of ripretinib treatment
Description of treatment reality in detail: 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)
Absolute dose intensity
Description of treatment reality in detail: Absolute dose intensity of ripretinib
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline
Previous local anticancer therapies per treatment line
Description of treatment reality in detail: Frequency of previous local anticancer therapies per treatment line
Time frame: Baseline
Previous systemic anticancer therapies per treatment setting
Description of treatment reality in detail: Frequency of previous systemic anticancer therapies per treatment setting
Time frame: Baseline
Previous systemic anticancer therapies per treatment line
Description of treatment reality in detail: Frequency of previous systemic anticancer therapies per treatment line
Time frame: Baseline
Concomitant local anticancer therapies
Description of treatment reality in detail: Frequency of concomitant local anticancer therapies (i.e., surgeries and radiotherapies)
Time frame: Baseline up to 30 days after ripretinib therapy
Subsequent local anticancer therapies
Description of treatment reality in detail: Frequency of subsequent local anticancer therapies
Time frame: From date of end of ripretinib treatment up to 36 months
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