NCT06619275已完成不适用
Ripretinib in Patients With Previously Treated Advanced Gastrointestinal Stromal Tumor (GIST): a Prospective, Longitudinal, Multicenter, Observational Study in Germany
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- iOMEDICO AG
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Evaluate Quality of Live (QoL): EQ-5D-5L index value
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Evaluate Quality of Live (QoL): EQ-5D-5L index value
时间窗: 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
Evaluate Quality of Live (QoL): EQ-Visual Analogue Scale (VAS)
时间窗: 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)
次要结局
- 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))
- Assess effectiveness in routine treatment: Overall Response Rate (ORR)(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)(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)(Baseline up to 30 days after ripretinib therapy)
- Assess drug safety: Incidence of (serious) treatment emergent adverse drug reactions (TEADRs)(Baseline up to 30 days after ripretinib therapy)
- Assess parameters of physicians' treatment decision making using a questionnaire(Baseline)
- 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(max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up))
- Relative dose intensity(max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up))
- Frequency of dose modifications(max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up))
- Type of dose modifications(max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up))
- Reasons of dose modifications(max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up))
- Duration of treatment(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)(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(Baseline)
- Previous local anticancer therapies per treatment line(Baseline)
- Previous systemic anticancer therapies per treatment setting(Baseline)
- Previous systemic anticancer therapies per treatment line(Baseline)
- Concomitant local anticancer therapies(Baseline up to 30 days after ripretinib therapy)
- Subsequent local anticancer therapies(From date of end of ripretinib treatment up to 36 months)
研究者
研究点 (1)
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