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 Type
OBSERVATIONAL
Enrollment
150
In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol
Banner Desert Medical Center
Mesa, Arizona, United States
WITHDRAWNCalifornia Research Inst.
Los Angeles, California, United States
RECRUITINGUSC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
WITHDRAWNUCLA - Mattel Children's Hospital
Los Angeles, California, United States
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
Objective response rate (ORR)
Time frame: Up to 8 years
Disease control rate (DCR)
Time frame: Up to 8 years
Duration of response (DOR)
Time frame: Up to 8 years
Time to response (TTR)
Time frame: Up to 8 years
Progression-free survival (PFS)
Time frame: Up to 8 years
Overall survival (OS)
Time frame: Up to 8 years
Total dose
Time frame: Up to 8 years
Starting and ending dose
Time frame: Up to 8 years
Dose modification during treatment
Time frame: Up to 8 years
Duration of treatment (DOT)
Time frame: Up to 8 years
ORR by patient subgroup(s)
Time frame: Up to 8 years
DCR by patient subgroup(s)
Time frame: Up to 8 years
DOR by patient subgroup(s)
Time frame: Up to 8 years
TTR by patient subgroup(s)
Time frame: Up to 8 years
PFS by patient subgroup(s)
Time frame: Up to 8 years
OS by patient subgroup(s)
Time frame: Up to 8 years
Number of patients with change in height and weight from baseline by visit, neurological abnormalities (normal/abnormal)
for all patients
Time frame: Up to 8 years
Number of patients with abnormal developmental milestones
Pediatric cohort only
Time frame: Up to 8 years
Number of patients with abnormal Tanner stage
Pediatric cohort only
Time frame: Up to 8 years
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Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
RECRUITINGUCSF Benioff Children's Hospital Oakland
Oakland, California, United States
WITHDRAWNStanford Univ Med Ctr. / Lucile Packard Children's Hosp
Palo Alto, California, United States
RECRUITINGProvidence Health System - Southern California
Santa Monica, California, United States
TERMINATEDLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States
WITHDRAWNSCL Health
Grand Junction, Colorado, United States
WITHDRAWN...and 66 more locations