PrOspective Non-interventional Study in Patients With Locally Advanced or Metastatic TRK Fusion Cancer Treated With Larotrectinib
概览
- 阶段
- 不适用
- 干预措施
- larotrectinib(Vitrakvi, BAY2757556)
- 疾病 / 适应症
- Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion
- 发起方
- Bayer
- 入组人数
- 150
- 试验地点
- 101
- 主要终点
- Number of participants with treatment-emergent adverse events (TEAEs)
- 状态
- 招募中
- 最后更新
- 18天前
概览
简要总结
In this observational study researcher want to learn more about the effectiveness of drug VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated during routine use in patients with TRK fusion cancer which is locally advanced or spread from the place where it started to other places in the body. TRK fusion cancer is a term used to describe a variety of common and rare cancers that are caused by a change to the NTRK (Neurotrophic Tyrosine Kinase) gene called a fusion. During this fusion, an NTRK gene joins together, or fuses, with a different gene. This joining results in the activation of certain proteins (TRK fusion proteins), which can cause cancer cells to multiply and form a tumor. VITRAKVI is an approved drug that blocks the action of the NTRK gene fusion. This study will enroll adult and paediatric patients suffering from a solid tumor with NTRK gene fusion for whom the decision to treat their disease with VITRAKVI has been made by their treating physicians. During the study, patients' medical information such as treatment information with VITRAKVI, other medication or treatments, changes in disease status and other health signs and symptoms will be collected within the normal medical care by the treating doctor. Participants will be observed over a period from 24 to 60 months.
研究者
入排标准
入选标准
- •Adult and pediatric (from birth to 18-year-old) patients
- •Patients with locally advanced or metastatic solid tumor harboring an NTRK gene fusion. NTRK (NTRK1, NTRK2, and NTRK3) gene fusions will be identified locally. Acceptable methods of detection of NTRK gene fusion include NGS, fluorescence in situ hybridization (FISH), reverse-transcription polymerase chain reaction (rt-PCR) or any other genomic testing able to detect NTRK gene fusion. If a pan-TRK IHC method is used, this result needs to be accompanied with the results using one of the other methods noted above.
- •Life expectancy of at least 3 months based on clinical judgement
- •Decision to treat with larotrectinib made by the treating physician prior to study enrollment
- •Patients can also be enrolled if the initial visit (larotrectinib start date) occurred within 2 months ±3 days prior to informed consent signed date
- •Signed informed consent form
- •For patients under legal age, signed assent by the patient (where applicable) and parental/legal guardian signed informed consent is required
排除标准
- •Any contraindications as listed in the local approved product information
- •Pregnancy
- •Participation in an investigational program with interventions outside of routine clinical practice
- •Prior treatment with larotrectinib or other kinase inhibitor with TRK inhibition
- •Patients with NTRK gene amplification or NTRK point mutation
研究组 & 干预措施
GI
adult patients with gastrointestinal (GI) cancer
干预措施: larotrectinib(Vitrakvi, BAY2757556)
H&N
adult patients with head and neck (H\&N) cancer
干预措施: larotrectinib(Vitrakvi, BAY2757556)
Lung
adult patients with lung cancer
干预措施: larotrectinib(Vitrakvi, BAY2757556)
Melanoma
adult patients with melanoma
干预措施: larotrectinib(Vitrakvi, BAY2757556)
other
patients with other tumor types
干预措施: larotrectinib(Vitrakvi, BAY2757556)
STS
adult patients with soft tissue sarcoma (STS)
干预措施: larotrectinib(Vitrakvi, BAY2757556)
CNS
adult patients with primary central nervous system (CNS) cancer
干预措施: larotrectinib(Vitrakvi, BAY2757556)
Pediatric
all pediatric patients regardless of tumor type will be enrolled under this cohort
干预措施: larotrectinib(Vitrakvi, BAY2757556)
结局指标
主要结局
Number of participants with treatment-emergent adverse events (TEAEs)
时间窗: Up to 30 days after last dose
Severity of TEAEs
时间窗: Up to 30 days after last dose
Seriousness of TEAEs
时间窗: Up to 30 days after last dose
Reasonable causal relationship between larotrectinib and an AE
时间窗: Up to 30 days after last dose
Causality of TEAEs
时间窗: Up to 30 days after last dose
Action taken related to larotrectinib treatment
时间窗: Up to 30 days after last dose
次要结局
- Duration of response (DOR)(Up to 8 years)
- ORR by patient subgroup(s)(Up to 8 years)
- OS by patient subgroup(s)(Up to 8 years)
- Disease control rate (DCR)(Up to 8 years)
- Progression-free survival (PFS)(Up to 8 years)
- Overall survival (OS)(Up to 8 years)
- Dose modification during treatment(Up to 8 years)
- DOR by patient subgroup(s)(Up to 8 years)
- TTR by patient subgroup(s)(Up to 8 years)
- PFS by patient subgroup(s)(Up to 8 years)
- Objective response rate (ORR)(Up to 8 years)
- DCR by patient subgroup(s)(Up to 8 years)
- Time to response (TTR)(Up to 8 years)
- Total dose(Up to 8 years)
- Starting and ending dose(Up to 8 years)
- Duration of treatment (DOT)(Up to 8 years)
- Number of patients with change in height and weight from baseline by visit, neurological abnormalities (normal/abnormal)(Up to 8 years)
- Number of patients with abnormal developmental milestones(Up to 8 years)
- Number of patients with abnormal Tanner stage(Up to 8 years)