PrOspective Non-interventional Study in Patients With Locally Advanced or Metastatic TRK Fusion Cancer Treated With Larotrectinib
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 102
- Primary Endpoint
- Number of participants with treatment-emergent adverse events (TEAEs)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
GI
adult patients with gastrointestinal (GI) cancer
Intervention: larotrectinib(Vitrakvi, BAY2757556) (Drug)
H&N
adult patients with head and neck (H&N) cancer
Intervention: larotrectinib(Vitrakvi, BAY2757556) (Drug)
other
patients with other tumor types
Intervention: larotrectinib(Vitrakvi, BAY2757556) (Drug)
Lung
adult patients with lung cancer
Intervention: larotrectinib(Vitrakvi, BAY2757556) (Drug)
Melanoma
adult patients with melanoma
Intervention: larotrectinib(Vitrakvi, BAY2757556) (Drug)
CNS
adult patients with primary central nervous system (CNS) cancer
Intervention: larotrectinib(Vitrakvi, BAY2757556) (Drug)
STS
adult patients with soft tissue sarcoma (STS)
Intervention: larotrectinib(Vitrakvi, BAY2757556) (Drug)
Pediatric
all pediatric patients regardless of tumor type will be enrolled under this cohort
Intervention: larotrectinib(Vitrakvi, BAY2757556) (Drug)
Outcomes
Primary Outcomes
Number of participants with treatment-emergent adverse events (TEAEs)
Time Frame: Up to 30 days after last dose
Severity of TEAEs
Time Frame: Up to 30 days after last dose
Seriousness of TEAEs
Time Frame: Up to 30 days after last dose
Reasonable causal relationship between larotrectinib and an AE
Time Frame: Up to 30 days after last dose
Causality of TEAEs
Time Frame: Up to 30 days after last dose
Action taken related to larotrectinib treatment
Time Frame: Up to 30 days after last dose
Secondary Outcomes
- 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)