Melanoma Clinical Trial
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
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.
Eligibility Criteria
Inclusion Criteria:
Adult and pediatric (from 1 month 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
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There are 45 Locations for this study
Gilbert Arizona, 85234, United States
Mesa Arizona, 05202, United States
Los Angeles California, 90027, United States
Los Angeles California, 90027, United States
Los Angeles California, 90095, United States
Newport Beach California, 82663, United States
Oakland California, 94609, United States
Palo Alto California, 94304, United States
Santa Monica California, 90404, United States
Torrance California, 90502, United States
Grand Junction Colorado, 81501, United States
New Haven Connecticut, 06520, United States
Jacksonville Florida, 32224, United States
Orlando Florida, 32827, United States
Plantation Florida, 33324, United States
Fort Wayne Indiana, 46804, United States
Terre Haute Indiana, 47802, United States
Wichita Kansas, 67214, United States
South Portland Maine, 04106, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21287, United States
Frederick Maryland, 21702, United States
Boston Massachusetts, 02215, United States
Farmington Hills Michigan, 48334, United States
Lansing Michigan, 48912, United States
Morristown New Jersey, 07960, United States
New Brunswick New Jersey, 08901, United States
Buffalo New York, 14210, United States
New York New York, 10065, United States
Staten Island New York, 10305, United States
Charlotte North Carolina, 28204, United States
Greenville North Carolina, 27834, United States
Columbus Ohio, 43210, United States
Youngstown Ohio, 44501, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15212, United States
Charleston South Carolina, 29425, United States
Memphis Tennessee, 38105, United States
Dallas Texas, 75390, United States
Murray Utah, 84107, United States
Saint George Utah, 84790, United States
Salt Lake City Utah, 84112, United States
Seattle Washington, 98105, United States
Morgantown West Virginia, 26506, United States
La Crosse Wisconsin, 54601, United States
Madison Wisconsin, 53717, United States
Multiple Locations , , Argentina
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Multiple Locations , , Greece
Multiple Locations , , Ireland
Multiple Locations , , Italy
Multiple Locations , , Japan
Multiple Locations , , Korea, Republic of
Multiple Locations , , Luxembourg
Multiple Locations , , Norway
Multiple Locations , , Russian Federation
Multiple Locations , , Singapore
Multiple Locations , , Spain
Multiple Locations , , Sweden
Multiple Locations , , Switzerland
Multiple Locations , , Taiwan
Multiple Locations , , United Kingdom
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