PrOspective Non-interventional study in patients with locally advanced or metastatic TRK fusion cancer treated with larotrectinib (ON-TRK)

Study identification

• EU PAS number:
  EUPAS32136
• Study ID:
  44357
• Official title and acronym:
  PrOspective Non-interventional study in patients with locally advanced or metastatic TRK fusion cancer treated with larotrectinib (ON-TRK)
• DARWIN EU® study:
  No
• Study countries:
  Argentina

  Australia

  Austria

  Belgium

  Brazil

  Canada

  Denmark

  Finland

  France

  Germany

  Greece

  Italy

  Korea, Republic of

  Luxembourg

  Norway

  Russian Federation

  Spain

  Switzerland

  Taiwan

  United Kingdom

  United States
• Study description:
  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.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Bayer AG

Study timelines

Date when funding contract was signed

Actual: 30/08/2019

Study start date

Planned: 30/03/2020

Actual: 03/04/2020

Date of final study report

Planned: 30/06/2030

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer AG

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

NCT04142437