Study to Learn More About the Safety and Effectiveness of the Drug VITRAKVI 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
- Conditions
- Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion
- Interventions
- Drug: larotrectinib(Vitrakvi, BAY2757556)
- Registration Number
- NCT04142437
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description GI larotrectinib(Vitrakvi, BAY2757556) adult patients with gastrointestinal (GI) cancer H&N larotrectinib(Vitrakvi, BAY2757556) adult patients with head and neck (H\&N) cancer STS larotrectinib(Vitrakvi, BAY2757556) adult patients with soft tissue sarcoma (STS) CNS larotrectinib(Vitrakvi, BAY2757556) adult patients with primary central nervous system (CNS) cancer Lung larotrectinib(Vitrakvi, BAY2757556) adult patients with lung cancer Melanoma larotrectinib(Vitrakvi, BAY2757556) adult patients with melanoma Pediatric larotrectinib(Vitrakvi, BAY2757556) all pediatric patients regardless of tumor type will be enrolled under this cohort other larotrectinib(Vitrakvi, BAY2757556) patients with other tumor types
- Primary Outcome Measures
Name Time Method Number of participants with treatment-emergent adverse events (TEAEs) Up to 30 days after last dose Severity of TEAEs Up to 30 days after last dose Seriousness of TEAEs Up to 30 days after last dose Reasonable causal relationship between larotrectinib and an AE Up to 30 days after last dose Causality of TEAEs Up to 30 days after last dose Action taken related to larotrectinib treatment Up to 30 days after last dose
- Secondary Outcome Measures
Name Time Method 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 Progression-free survival (PFS) Up to 8 years 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 Overall survival (OS) Up to 8 years Dose modification during treatment 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 for all patients
Number of patients with abnormal developmental milestones Up to 8 years Pediatric cohort only
Number of patients with abnormal Tanner stage Up to 8 years Pediatric cohort only
Related Research Topics
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Trial Locations
- Locations (52)
Banner Desert Medical Center
🇺🇸Mesa, Arizona, United States
California Research Inst.
🇺🇸Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
UCLA - Mattel Children's Hospital
🇺🇸Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
UCSF Benioff Children's Hospital Oakland
🇺🇸Oakland, California, United States
Stanford Univ Med Ctr. / Lucile Packard Children's Hosp
🇺🇸Palo Alto, California, United States
Providence Health System - Southern California
🇺🇸Santa Monica, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
SCL Health
🇺🇸Grand Junction, Colorado, United States
Scroll for more (42 remaining)Banner Desert Medical Center🇺🇸Mesa, Arizona, United States