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| Name | Class |
|---|---|
| Deciphera Pharmaceuticals (Switzerland) AG | UNKNOWN |
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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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ripretinib | Drug | Switch-Control Tyrosine Kinase Inhibitor |
| 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) |
| 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) |
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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:
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Adult patients diagnosed with advanced GIST who received 3 or more tyrosine kinase inhibitors (including imatinib).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Praxis für interdisziplinäre Onkologie und Hämatologie | Freiburg im Breisgau | Germany |
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| ID | Term |
|---|---|
| D046152 | Gastrointestinal Stromal Tumors |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000707850 | ripretinib |
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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 |
| Assess parameters of physicians' treatment decision making using a questionnaire | Frequency of distinct parameters affecting therapy choice; questionnaire completed by treating physician. | Baseline |
| 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 |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |