Vanderbilt Clinical Trials

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

Purpose

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.

Condition

Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion

Eligibility

Eligible Ages: All ages
Eligible Genders: All
Accepts Healthy Volunteers: No

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 - 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

Study Design

Phase
Study Type: Observational
Observational Model: Cohort
Time Perspective: Prospective

Arm Groups

Arm	Description	Assigned Intervention
GI	adult patients with gastrointestinal (GI) cancer	Drug: larotrectinib(Vitrakvi, BAY2757556) 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
H&N	adult patients with head and neck (H&N) cancer	Drug: larotrectinib(Vitrakvi, BAY2757556) 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
STS	adult patients with soft tissue sarcoma (STS)	Drug: larotrectinib(Vitrakvi, BAY2757556) 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
CNS	adult patients with primary central nervous system (CNS) cancer	Drug: larotrectinib(Vitrakvi, BAY2757556) 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
Lung	adult patients with lung cancer	Drug: larotrectinib(Vitrakvi, BAY2757556) 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
Melanoma	adult patients with melanoma	Drug: larotrectinib(Vitrakvi, BAY2757556) 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
Pediatric	all pediatric patients regardless of tumor type will be enrolled under this cohort	Drug: larotrectinib(Vitrakvi, BAY2757556) 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
other	patients with other tumor types	Drug: larotrectinib(Vitrakvi, BAY2757556) 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

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232

More Details

Status: Recruiting
Sponsor: Bayer

Study Contact

Bayer Clinical Trials Contact
(+)1-888-84 22937
clinical-trials-contact@bayer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.