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NTRK Gene Fusion - Positive Advanced or Recurrent Solid Tumors, a Rare Cancer Caused by Specific Changes in the Genes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04945330
Recruitment Status : Not yet recruiting
First Posted : June 30, 2021
Last Update Posted : August 26, 2021
Information provided by (Responsible Party):

Brief Summary:

Researchers want to learn more about the use of larotrectinib as a real-world treatment for tropomyosin receptor kinase fusion cancer, also called TRK fusion cancer.

In people with TRK fusion cancer, a gene called neurotrophic TRK, (NTRK) joins or "fuses" with another gene. This creates a protein known as a fusion protein, which can cause cancer cells to grow. The study treatment, larotrectinib, is already available for doctors to prescribe to patients with TRK fusion cancer. Larotrectinib works by blocking TRK genes in cancer cells which helps stop the cancer from growing.

In this study, the researchers want to learn more about the safety and effectiveness of larotrectinib in adults and children with advanced or recurrent TRK fusion cancer. This means that their cancer has spread from where it started to other areas of the body, or the cancer has come back after a period of time. To answer this question, the researchers will collect information from patients who are taking larotrectinib as prescribed by their doctors. The researchers will learn what adverse events the patients are having. An adverse event is any medical problem that a patient has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

The study will include patients of all ages with TRK fusion cancer.

In this study, there will be no required tests or visits to a study site. Instead, the researchers will collect information from:

  • the patients' medical records
  • interviews with the patients or their parents or guardians
  • the patients' visits to their doctor as part of their usual care The researchers will collect information about the adults for up to about 2 years and about the children for up to about 8 years.

Condition or disease Intervention/treatment
Advanced or Recurrent Solid Tumor Harboring an NTRK Gene Fusion Drug: Larotrectinib (Vitrakvi, BAY2757556)

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Drug Use Investigation for Larotrectinib
Estimated Study Start Date : September 30, 2021
Estimated Primary Completion Date : June 30, 2029
Estimated Study Completion Date : December 31, 2029

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Gastrointestinal (GI)
Participants with GI cancer.
Drug: Larotrectinib (Vitrakvi, BAY2757556)
Follow clinical practice

Head and neck (H&N)
Participants with H&N cancer.
Drug: Larotrectinib (Vitrakvi, BAY2757556)
Follow clinical practice

Participants with lung cancer.
Drug: Larotrectinib (Vitrakvi, BAY2757556)
Follow clinical practice

Soft tissue sarcoma (STS)
Participants with STS cancer.
Drug: Larotrectinib (Vitrakvi, BAY2757556)
Follow clinical practice

Primary central nervous system (CNS)
Participants with CNS cancer.
Drug: Larotrectinib (Vitrakvi, BAY2757556)
Follow clinical practice

Participants with Melanoma cancer.
Drug: Larotrectinib (Vitrakvi, BAY2757556)
Follow clinical practice

Pediatrics Drug: Larotrectinib (Vitrakvi, BAY2757556)
Follow clinical practice

Others Drug: Larotrectinib (Vitrakvi, BAY2757556)
Follow clinical practice

Primary Outcome Measures :
  1. Severity of treatment emergent adverse events (TEAEs) [ Time Frame: Approximate 8 years ]
  2. Frequency of TEAEs [ Time Frame: Approximate 8 years ]
  3. Seriousness of TEAEs [ Time Frame: Approximate 8 years ]
  4. Outcome of TEAEs [ Time Frame: Approximate 8 years ]
  5. Causality assessment of TEAEs [ Time Frame: Approximate 8 years ]

Secondary Outcome Measures :
  1. Overall response rate (ORR), based on investigator assessment preferably using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or Response Assessment in Neuro-Oncology (RANO) as appropriate by local investigator assessment [ Time Frame: Approximate 8 years ]
  2. Disease control rate (DCR) [ Time Frame: Approximate 8 years ]
  3. Duration of response (DOR) [ Time Frame: Approximate 8 years ]
  4. Time to response (TTR) [ Time Frame: Approximate 8 years ]
  5. Progression-free survival (PFS) [ Time Frame: Approximate 8 years ]
  6. Overall survival (OS) [ Time Frame: Approximate 8 years ]
  7. Total dose [ Time Frame: Approximate 8 years ]
  8. Starting and ending dose [ Time Frame: Approximate 8 years ]
  9. Dose modification during treatment [ Time Frame: Approximate 8 years ]
  10. Duration of treatment (DOT) [ Time Frame: Approximate 8 years ]
  11. Baseline characteristics [ Time Frame: Approximate 8 years ]
    Including but not limited to: age, NTRK gene, NTRK gene partner, prior therapy (type, number of lines of therapy), other.

  12. Neurological examination (normal/abnormal) [ Time Frame: Approximate 8 years ]
  13. Change in height from baseline by visit [ Time Frame: Approximate 8 years ]
  14. Change in weight from baseline by visit [ Time Frame: Approximate 8 years ]
  15. Developmental milestones abnormalities (normal/abnormal) [ Time Frame: Approximate 8 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult and pediatric (from birth to 18 year old) patients treated with larotrectinib.

Inclusion Criteria:

  • Patients who are treated with larotrectinib or decided to be treated with larotrectinib, under routine clinical practice.

Exclusion Criteria:

  • Participation in an investigational program with interventions outside of routine clinical practice

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04945330

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Contact: Bayer Clinical Trials Contact (+)1-888-84 22937

Sponsors and Collaborators
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Responsible Party: Bayer Identifier: NCT04945330    
Other Study ID Numbers: 21793
First Posted: June 30, 2021    Key Record Dates
Last Update Posted: August 26, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No