account_circleRecruiting
locally advanced or metastatic solid tumor harboring an NTRK gene fusion
Bayer Identifier:
20324
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial 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.
Key Participants Requirements
Sex
AllAge
NaN - N/ATrial summary
Enrollment Goal
150Trial Dates
April 2020 - March 2030Phase
Phase 4Could I Receive a placebo
NoProducts
Vitrakvi (Larotrectinib, BAY2757556)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Active, not recruiting | Many Locations | Many Locations, Canada |
Recruiting | MD Anderson Cancer Center | Houston, 77030, United States |
Recruiting | Hoag Memorial Hospital Presbyterian | Newport Beach, 82663, United States |
Recruiting | UT Southwestern Medical Center / Children's Health | Dallas, 75390, United States |
Recruiting | UCLA - Mattel Children's Hospital | Los Angeles, 90095, United States |
Withdrawn | St. Jude Children's Research Hospital | Memphis, 38105, United States |
Withdrawn | Regional Health Hope Center | Terre Haute, 47802, United States |
Withdrawn | University of Pennsylvania (Penn Med) | Philadelphia, 19104, United States |
Recruiting | Seattle Children's | Seattle, 98105, United States |
Recruiting | Stanford Univ Med Ctr. / Lucile Packard Children's Hosp | Palo Alto, 94304, United States |
Recruiting | Johns Hopkins / Sidney Kimmel Cancer Center | Baltimore, 21205, United States |
Withdrawn | USC / Norris Comprehensive Cancer Center | Los Angeles, 90089, United States |
Withdrawn | Nemours Children's Hospital | Orlando, 32827, United States |
Withdrawn | Intermountain Healthcare - Intermountain Medical Center | Murray, 84107, United States |
Withdrawn | Rutgers Cancer Institute of New Jersey | New Brunswick, 08901, United States |
Withdrawn | Staten Island Univ. Hospital (Northwell Health) | Staten Island, 10305, United States |
Withdrawn | Banner Desert Medical Center | Mesa, 85202, United States |
Recruiting | University of Miami | Miami, 33146, United States |
Recruiting | Yale University | New Haven, 06520, United States |
Recruiting | Medical Univ. of South Carolina | Charleston, 29425, United States |
Recruiting | Fort Wayne Medical Oncology Hematology | Fort Wayne, 46804, United States |
Recruiting | West Virginia University | Morgantown, 26506, United States |
Recruiting | Maine Health | South Portland, 04106, United States |
Withdrawn | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance, 90502, United States |
Recruiting | Univ. of Utah / Huntsman Cancer Center | Salt Lake City, 84112, United States |
Withdrawn | Levine Cancer Center | Charlotte, 28204, United States |
Withdrawn | Mayo Clinic | Jacksonville, 32224, United States |
Withdrawn | Intermountain Healthcare - Dixie Regional Medical Center | St. George, 84790, United States |
Withdrawn | Univ. of Maryland / Greenebaum Comp. Cancer Ctr. | Baltimore, 21201, United States |
Withdrawn | SCL Health | Grand Junction, 81501, United States |
Recruiting | California Research Inst. | Los Angeles, 90027, United States |
Withdrawn | Ohio State Comp. Cancer Ctr. / James Cancer Hospital | Columbus, 43210, United States |
Terminated | Allegheny Health Network | Pittsburgh, 15212, United States |
Recruiting | East Carolina University / Vidant Health | Greenville, 27834, United States |
Withdrawn | UCSF Benioff Children's Hospital Oakland | Oakland, 94609, United States |
Withdrawn | Boston Children's / Dana Farber | Boston, 02215, United States |
Recruiting | Detroit Clinical Research Center | Farmington Hills, 48334, United States |
Withdrawn | Atlantic Hem Onc / Morristown Medical Center | Morristown, 07960, United States |
Recruiting | Gundersen Health System | La Crosse, 54601, United States |
Recruiting | Sparrow Cancer Center | Lansing, 48912, United States |
Terminated (Halted Prematurely) | SSM Health Cancer Center - Dean Medical Group | Madison, 53717, United States |
Recruiting | Mercy Health Youngstown | Youngstown, 44501, United States |
Terminated | Great Lakes Cancer Center | Buffalo, 14210, United States |
Terminated | Providence Health System - Southern California | Santa Monica, 90404, United States |
Recruiting | Memorial Sloan Kettering Children's Cancer Center | New York, 10065, United States |
Recruiting | Cancer Center of Kansas | Wichita, 67214, United States |
Terminated (Halted Prematurely) | Frederick Health-James M Stockman Cancer Institute | Frederick, 21702, United States |
Active, not recruiting | Many Locations | Many Locations, Belgium |
Active, not recruiting | Many Locations | Many Locations, Switzerland |
Active, not recruiting | Many Locations | Many Locations, Sweden |
Active, not recruiting | Many Locations | Many Locations, Germany |
Active, not recruiting | Many Locations | Many Locations, France |
Active, not recruiting | Many Locations | Many Locations, Argentina |
Active, not recruiting | Many Locations | Many Locations, Austria |
Not yet recruiting | Many Locations | Many Locations, Australia |
Withdrawn | Many Locations | Many Locations, Brazil |
Active, not recruiting | Many Locations | Many Locations, China |
Withdrawn | Many Locations | Many Locations, Denmark |
Active, not recruiting | Many Locations | Many Locations, Spain |
Active, not recruiting | Many Locations | Many Locations, Finland |
Not yet recruiting | Many Locations | Many Locations, United Kingdom |
Not yet recruiting | Many Locations | Many Locations, Greece |
Withdrawn | Many Locations | Many Locations, Ireland |
Active, not recruiting | Many Locations | Many Locations, Italy |
Withdrawn | Many Locations | Many Locations, Japan |
Active, not recruiting | Many Locations | Many Locations, Korea,_republic_of |
Active, not recruiting | Many Locations | Many Locations, Luxembourg |
Withdrawn | Many Locations | Many Locations, Norway |
Withdrawn | Many Locations | Many Locations, Russia |
Withdrawn | Many Locations | Many Locations, Singapore |
Not yet recruiting | Many Locations | Many Locations, Taiwan |
Recruiting | Vanderbilt University Medical Center | Nashville, 37232, United States |
Recruiting | Nevada Cancer Research Foundation | Las Vegas, 89169, United States |
Recruiting | Tufts / Neely Cancer Center | Boston, 02111, United States |
Recruiting | Children’s Hospital of Philadelphia | Philadelphia, 19104, United States |
Recruiting | Nicklaus Children's Hospital | Miami, 33155, United States |
Primary Outcome
- Number of participants with treatment-emergent adverse events (TEAEs)date_rangeTime Frame:Up to 30 days after last dose
- Severity of TEAEsdate_rangeTime Frame:Up to 30 days after last dose
- Seriousness of TEAEsdate_rangeTime Frame:Up to 30 days after last dose
- Reasonable causal relationship between larotrectinib and an AEdate_rangeTime Frame:Up to 30 days after last dose
- Causality of TEAEsdate_rangeTime Frame:Up to 30 days after last dose
- Action taken related to larotrectinib treatmentdate_rangeTime Frame:Up to 30 days after last dose
Secondary Outcome
- Objective response rate (ORR)date_rangeTime Frame:Up to 8 years
- Disease control rate (DCR)date_rangeTime Frame:Up to 8 years
- Duration of response (DOR)date_rangeTime Frame:Up to 8 years
- Time to response (TTR)date_rangeTime Frame:Up to 8 years
- Progression-free survival (PFS)date_rangeTime Frame:Up to 8 years
- Overall survival (OS)date_rangeTime Frame:Up to 8 years
- Total dosedate_rangeTime Frame:Up to 8 years
- Starting and ending dosedate_rangeTime Frame:Up to 8 years
- Dose modification during treatmentdate_rangeTime Frame:Up to 8 years
- Duration of treatment (DOT)date_rangeTime Frame:Up to 8 years
- ORR by patient subgroup(s)date_rangeTime Frame:Up to 8 years
- DCR by patient subgroup(s)date_rangeTime Frame:Up to 8 years
- DOR by patient subgroup(s)date_rangeTime Frame:Up to 8 years
- TTR by patient subgroup(s)date_rangeTime Frame:Up to 8 years
- PFS by patient subgroup(s)date_rangeTime Frame:Up to 8 years
- OS by patient subgroup(s)date_rangeTime Frame:Up to 8 years
- Number of patients with change in height and weight from baseline by visit, neurological abnormalities (normal/abnormal)for all patientsdate_rangeTime Frame:Up to 8 years
- Number of patients with abnormal developmental milestonesPediatric cohort onlydate_rangeTime Frame:Up to 8 years
- Number of patients with abnormal Tanner stagePediatric cohort onlydate_rangeTime Frame:Up to 8 years
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A