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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04142437
Other study ID # 20324
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 3, 2020
Est. completion date March 31, 2030

Study information

Verified date June 2024
Source Bayer
Contact Bayer Clinical Trials Contact
Phone (+)1-888-84 22937
Email clinical-trials-contact@bayer.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date March 31, 2030
Est. primary completion date November 30, 2029
Accepts healthy volunteers No
Gender All
Age group 1 Month and older
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion

Intervention

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

Locations

Country Name City State
Argentina Many Locations Multiple Locations
Australia Many Locations Multiple Locations
Austria Many Locations Multiple Locations
Belgium Many Locations Multiple Locations
Brazil Many Locations Multiple Locations
Canada Many Locations Multiple Locations
China Many Locations Multiple Locations
Denmark Many Locations Multiple Locations
Finland Many Locations Multiple Locations
France Many Locations Multiple Locations
Germany Many Locations Multiple Locations
Greece Many Locations Multiple Locations
Ireland Many Locations Multiple Locations
Italy Many Locations Multiple Locations
Japan Many Locations Multiple Locations
Korea, Republic of Many Locations Multiple Locations
Luxembourg Many Locations Multiple Locations
Norway Many Locations Multiple Locations
Russian Federation Many Locations Multiple Locations
Singapore Many Locations Multiple Locations
Spain Many Locations Multiple Locations
Sweden Many Locations Multiple Locations
Switzerland Many Locations Multiple Locations
Taiwan Many Locations Multiple Locations
United Kingdom Many Locations Multiple Locations
United States Johns Hopkins / Sidney Kimmel Cancer Center Baltimore Maryland
United States Univ. of Maryland / Greenebaum Comp. Cancer Ctr. Baltimore Maryland
United States Boston Children's / Dana Farber Boston Massachusetts
United States Tufts / Neely Cancer Center Boston Massachusetts
United States Great Lakes Cancer Center Buffalo New York
United States Medical Univ. of South Carolina Charleston South Carolina
United States Levine Cancer Center Charlotte North Carolina
United States Ohio State Comp. Cancer Ctr. / James Cancer Hospital Columbus Ohio
United States UT Southwestern Medical Center / Children's Health Dallas Texas
United States Detroit Clinical Research Center Farmington Hills Michigan
United States Fort Wayne Medical Oncology Hematology Fort Wayne Indiana
United States Frederick Health-James M Stockman Cancer Institute Frederick Maryland
United States SCL Health Grand Junction Colorado
United States East Carolina University / Vidant Health Greenville North Carolina
United States MD Anderson Cancer Center Houston Texas
United States Mayo Clinic Jacksonville Florida
United States Gundersen Health System La Crosse Wisconsin
United States Sparrow Cancer Center Lansing Michigan
United States Nevada Cancer Research Foundation Las Vegas Nevada
United States California Research Inst. Los Angeles California
United States UCLA - Mattel Children's Hospital Los Angeles California
United States USC / Norris Comprehensive Cancer Center Los Angeles California
United States SSM Health Cancer Center - Dean Medical Group Madison Wisconsin
United States St. Jude Children's Research Hospital Memphis Tennessee
United States Banner Desert Medical Center Mesa Arizona
United States Nicklaus Children's Hospital Miami Florida
United States University of Miami Miami Florida
United States West Virginia University Morgantown West Virginia
United States Atlantic Hem Onc / Morristown Medical Center Morristown New Jersey
United States Intermountain Healthcare - Intermountain Medical Center Murray Utah
United States Vanderbilt University Medical Center Nashville Tennessee
United States Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
United States Yale University New Haven Connecticut
United States Memorial Sloan Kettering Children's Cancer Center New York New York
United States Hoag Memorial Hospital Presbyterian Newport Beach California
United States UCSF Benioff Children's Hospital Oakland Oakland California
United States Nemours Children's Hospital Orlando Florida
United States Stanford Univ Med Ctr. / Lucile Packard Children's Hosp Palo Alto California
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 Intermountain Healthcare - Dixie Regional Medical Center Saint George Utah
United States Univ. of Utah / Huntsman Cancer Center Salt Lake City Utah
United States Providence Health System - Southern California Santa Monica California
United States Seattle Children's Seattle Washington
United States Maine Health South Portland Maine
United States Staten Island Univ. Hospital (Northwell Health) Staten Island New York
United States Regional Health Hope Center Terre Haute Indiana
United States Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance California
United States Cancer Center of Kansas Wichita Kansas
United States Mercy Health Youngstown Youngstown Ohio

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  China,  Denmark,  Finland,  France,  Germany,  Greece,  Ireland,  Italy,  Japan,  Korea, Republic of,  Luxembourg,  Norway,  Russian Federation,  Singapore,  Spain,  Sweden,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with treatment-emergent adverse events (TEAEs) Up to 30 days after last dose
Primary Severity of TEAEs Up to 30 days after last dose
Primary Seriousness of TEAEs Up to 30 days after last dose
Primary Outcome of TEAEs Up to 30 days after last dose
Primary Causality of TEAEs Up to 30 days after last dose
Primary Action taken related to larotrectinib treatment Up to 30 days after last dose
Secondary Objective response rate (ORR) Up to 8 years
Secondary Disease control rate (DCR) Up to 8 years
Secondary Duration of response (DOR) Up to 8 years
Secondary Time to response (TTR) Up to 8 years
Secondary Progression-free survival (PFS) Up to 8 years
Secondary Overall survival (OS) Up to 8 years
Secondary Total dose Up to 8 years
Secondary Starting and ending dose Up to 8 years
Secondary Dose modification during treatment Up to 8 years
Secondary Duration of treatment (DOT) Up to 8 years
Secondary ORR by patient subgroup(s) Up to 8 years
Secondary DCR by patient subgroup(s) Up to 8 years
Secondary DOR by patient subgroup(s) Up to 8 years
Secondary TTR by patient subgroup(s) Up to 8 years
Secondary PFS by patient subgroup(s) Up to 8 years
Secondary OS by patient subgroup(s) Up to 8 years
Secondary Number of patients with change in height and weight from baseline by visit, neurological abnormalities (normal/abnormal) for all patients Up to 8 years
Secondary Number of patients with abnormal developmental milestones Pediatric cohort only Up to 8 years
Secondary Number of patients with abnormal Tanner stage Pediatric cohort only Up to 8 years
See also
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