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.

View Eligibility Criteria

Eligibility Criteria

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
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

Study is for people with:

Melanoma

Estimated Enrollment:

300

Study ID:

NCT04142437

Recruitment Status:

Recruiting

Sponsor:

Bayer

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There are 45 Locations for this study

See Locations Near You

MD Anderson Cancer Center
Gilbert Arizona, 85234, United States
Banner Desert Medical Center
Mesa Arizona, 05202, United States
California Research Inst.
Los Angeles California, 90027, United States
USC / Norris Comprehensive Cancer Center
Los Angeles California, 90027, United States
UCLA - Mattel Children's Hospital
Los Angeles California, 90095, United States
Hoag Memorial Hospital Presbyterian
Newport Beach California, 82663, United States
UCSF Benioff Children's Hospital Oakland
Oakland California, 94609, United States
Stanford Univ Med Ctr. / Lucile Packard Children's Hosp
Palo Alto California, 94304, United States
Providence Health System - Southern California
Santa Monica California, 90404, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance California, 90502, United States
SCL Health
Grand Junction Colorado, 81501, United States
Yale University
New Haven Connecticut, 06520, United States
Mayo Clinic
Jacksonville Florida, 32224, United States
Nemours Children's Hospital
Orlando Florida, 32827, United States
University of Miami
Plantation Florida, 33324, United States
Fort Wayne Medical Oncology Hematology
Fort Wayne Indiana, 46804, United States
Regional Health Hope Center
Terre Haute Indiana, 47802, United States
Cancer Center of Kansas
Wichita Kansas, 67214, United States
Maine Health
South Portland Maine, 04106, United States
Univ. of Maryland / Greenebaum Comp. Cancer Ctr.
Baltimore Maryland, 21201, United States
Johns Hopkins / Sidney Kimmel Cancer Center
Baltimore Maryland, 21287, United States
Frederick Health-James M Stockman Cancer Institute
Frederick Maryland, 21702, United States
Boston Children's / Dana Farber
Boston Massachusetts, 02215, United States
Detroit Clinical Research Center
Farmington Hills Michigan, 48334, United States
Sparrow Cancer Center
Lansing Michigan, 48912, United States
Atlantic Hem Onc / Morristown Medical Center
Morristown New Jersey, 07960, United States
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States
Great Lakes Cancer Center
Buffalo New York, 14210, United States
Memorial Sloan Kettering Children's Cancer Center
New York New York, 10065, United States
Staten Island Univ. Hospital (Northwell Health)
Staten Island New York, 10305, United States
Levine Cancer Center
Charlotte North Carolina, 28204, United States
East Carolina University / Vidant Health
Greenville North Carolina, 27834, United States
Ohio State Comp. Cancer Ctr. / James Cancer Hospital
Columbus Ohio, 43210, United States
Mercy Health Youngstown
Youngstown Ohio, 44501, United States
University of Pennsylvania (Penn Med)
Philadelphia Pennsylvania, 19104, United States
Allegheny Health Network
Pittsburgh Pennsylvania, 15212, United States
Medical Univ. of South Carolina
Charleston South Carolina, 29425, United States
St. Jude Children's Research Hospital
Memphis Tennessee, 38105, United States
UT Southwestern Medical Center / Children's Health
Dallas Texas, 75390, United States
Intermountain Healthcare - Intermountain Medical Center
Murray Utah, 84107, United States
Intermountain Healthcare - Dixie Regional Medical Center
Saint George Utah, 84790, United States
Univ. of Utah / Huntsman Cancer Center
Salt Lake City Utah, 84112, United States
Seattle Children's
Seattle Washington, 98105, United States
West Virginia University
Morgantown West Virginia, 26506, United States
Gundersen Health System
La Crosse Wisconsin, 54601, United States
SSM Health Cancer Center - Dean Medical Group
Madison Wisconsin, 53717, United States
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How clear is this clinincal trial information?

Study is for people with:

Melanoma

Estimated Enrollment:

300

Study ID:

NCT04142437

Recruitment Status:

Recruiting

Sponsor:


Bayer

How clear is this clinincal trial information?

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