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 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 Dose modification during treatment 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 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
Trial Locations
- Locations (52)
Seattle Children's
🇺🇸Seattle, Washington, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
Gundersen Health System
🇺🇸La Crosse, Wisconsin, United States
SSM Health Cancer Center - Dean Medical Group
🇺🇸Madison, Wisconsin, United States
Many Locations
🇬🇧Multiple Locations, United Kingdom
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
Yale University
🇺🇸New Haven, Connecticut, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
University of Miami
🇺🇸Miami, Florida, United States
Nicklaus Children's Hospital
🇺🇸Miami, Florida, United States
Nemours Children's Hospital
🇺🇸Orlando, Florida, United States
Fort Wayne Medical Oncology Hematology
🇺🇸Fort Wayne, Indiana, United States
Regional Health Hope Center
🇺🇸Terre Haute, Indiana, United States
Cancer Center of Kansas
🇺🇸Wichita, Kansas, United States
Maine Health
🇺🇸South Portland, Maine, United States
Univ. of Maryland / Greenebaum Comp. Cancer Ctr.
🇺🇸Baltimore, Maryland, United States
Johns Hopkins / Sidney Kimmel Cancer Center
🇺🇸Baltimore, Maryland, United States
Frederick Health-James M Stockman Cancer Institute
🇺🇸Frederick, Maryland, United States
Tufts / Neely Cancer Center
🇺🇸Boston, Massachusetts, United States
Boston Children's / Dana Farber
🇺🇸Boston, Massachusetts, United States
Detroit Clinical Research Center
🇺🇸Farmington Hills, Michigan, United States
Sparrow Cancer Center
🇺🇸Lansing, Michigan, United States
Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Atlantic Hem Onc / Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Great Lakes Cancer Center
🇺🇸Buffalo, New York, United States
Memorial Sloan Kettering Children's Cancer Center
🇺🇸New York, New York, United States
Staten Island Univ. Hospital (Northwell Health)
🇺🇸Staten Island, New York, United States
Levine Cancer Center
🇺🇸Charlotte, North Carolina, United States
East Carolina University / Vidant Health
🇺🇸Greenville, North Carolina, United States
Ohio State Comp. Cancer Ctr. / James Cancer Hospital
🇺🇸Columbus, Ohio, United States
Mercy Health Youngstown
🇺🇸Youngstown, Ohio, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
University of Pennsylvania (Penn Med)
🇺🇸Philadelphia, Pennsylvania, United States
Allegheny Health Network
🇺🇸Pittsburgh, Pennsylvania, United States
Medical Univ. of South Carolina
🇺🇸Charleston, South Carolina, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
UT Southwestern Medical Center / Children's Health
🇺🇸Dallas, Texas, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Intermountain Healthcare - Intermountain Medical Center
🇺🇸Murray, Utah, United States
Intermountain Healthcare - Dixie Regional Medical Center
🇺🇸Saint George, Utah, United States
Univ. of Utah / Huntsman Cancer Center
🇺🇸Salt Lake City, Utah, United States