Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion Clinical Trial
— ON-TRKOfficial title:
PrOspective Non-interventional Study in Patients With Locally Advanced or Metastatic TRK Fusion Cancer Treated With Larotrectinib
| 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 |
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.
| 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 |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Bayer |
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,
| 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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