Trial Condition(s):
locally advanced or metastatic solid tumor harboring an NTRK gene fusion
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 (ON-TRK)
Bayer Identifier:
20324
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Many Locations Many Locations, Canada | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MD Anderson Cancer Center Houston, United States, 77030 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hoag Memorial Hospital Presbyterian Newport Beach, United States, 82663 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UT Southwestern Medical Center / Children's Health Dallas, United States, 75390 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UCLA - Mattel Children's Hospital Los Angeles, United States, 90095 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St. Jude Children's Research Hospital Memphis, United States, 38105 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Seattle Children's Seattle, United States, 98105 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Stanford Univ Med Ctr. / Lucile Packard Children's Hosp Palo Alto, United States, 94304 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Johns Hopkins / Sidney Kimmel Cancer Center Baltimore, United States, 21231 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Staten Island Univ. Hospital (Northwell Health) Staten Island, United States, 10305 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Miami Miami, United States, 33136 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Yale University New Haven, United States, 06520 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medical Univ. of South Carolina Charleston, United States, 29425 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fort Wayne Medical Oncology Hematology Fort Wayne, United States, 46804 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations West Virginia University Morgantown, United States, 26506 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Maine Health South Portland, United States, 04106 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance, United States, 90502 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Univ. of Utah / Huntsman Cancer Center Salt Lake City, United States, 84112 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations California Research Inst. Los Angeles, United States, 90027 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Allegheny Health Network Pittsburgh, United States, 15212 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations East Carolina University / Vidant Health Greenville, United States, 27834 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Detroit Clinical Research Center Farmington Hills, United States, 48334 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gundersen Health System La Crosse, United States, 54601 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sparrow Cancer Center Lansing, United States, 48912 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations SSM Health Cancer Center - Dean Medical Group Madison, United States, 53717 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Mercy Health Youngstown Youngstown, United States, 44501 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Great Lakes Cancer Center Buffalo, United States, 14210 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Providence Health System - Southern California Santa Monica, United States, 90404 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Memorial Sloan Kettering Children's Cancer Center New York, United States, 10065 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cancer Center of Kansas Wichita, United States, 67214 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Frederick Health-James M Stockman Cancer Institute Frederick, United States, 21702 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Belgium | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Switzerland | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Sweden | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Germany | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, France | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Argentina | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Austria | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Australia | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Brazil | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, China | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Spain | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Finland | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, United Kingdom | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Greece | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Italy | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, South Korea | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Luxembourg | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Russia | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Taiwan, China | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vanderbilt University Medical Center Nashville, United States, 37232 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nevada Cancer Research Foundation Las Vegas, United States, 89169 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tufts / Neely Cancer Center Boston, United States, 02111 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Children’s Hospital of Philadelphia Philadelphia, United States, 19104 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nicklaus Children's Hospital Miami, United States, 33155 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
PrOspective Non-interventional study in patients with locally advanced or metastatic TRK fusion cancer treated with larotrectinib
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
8
Primary Outcome
- Number of participants with treatment-emergent adverse events (TEAEs)Timeframe: Up to 30 days after last dose
- Severity of TEAEsTimeframe: Up to 30 days after last dose
- Seriousness of TEAEsTimeframe: Up to 30 days after last dose
- Outcome of TEAEsTimeframe: Up to 30 days after last dose
- Causality of TEAEsTimeframe: Up to 30 days after last dose
- Action taken related to larotrectinib treatmentTimeframe: Up to 30 days after last dose
Secondary Outcome
- Objective response rate (ORR)Timeframe: Up to 8 years
- Disease control rate (DCR)Timeframe: Up to 8 years
- Duration of response (DOR)Timeframe: Up to 8 years
- Time to response (TTR)Timeframe: Up to 8 years
- Progression-free survival (PFS)Timeframe: Up to 8 years
- Overall survival (OS)Timeframe: Up to 8 years
- Total doseTimeframe: Up to 8 years
- Starting and ending doseTimeframe: Up to 8 years
- Dose modification during treatmentTimeframe: Up to 8 years
- Duration of treatment (DOT)Timeframe: Up to 8 years
- ORR by patient subgroup(s)Timeframe: Up to 8 years
- DCR by patient subgroup(s)Timeframe: Up to 8 years
- DOR by patient subgroup(s)Timeframe: Up to 8 years
- TTR by patient subgroup(s)Timeframe: Up to 8 years
- PFS by patient subgroup(s)Timeframe: Up to 8 years
- OS by patient subgroup(s)Timeframe: Up to 8 years
- Number of patients with change in height and weight from baseline by visit, neurological abnormalities (normal/abnormal)for all patientsTimeframe: Up to 8 years
- Number of patients with abnormal developmental milestonesPediatric cohort onlyTimeframe: Up to 8 years
- Number of patients with abnormal Tanner stagePediatric cohort onlyTimeframe: Up to 8 years
Additional Information
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