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

NCT04945330 | Recruiting

• 1 other identifier: 21793
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced or Recurrent Solid Tumor Harboring an NTRK Gene Fusion

Outcome Measures

Primary Outcomes (5)

• Severity of treatment emergent adverse events (TEAEs)

  Approximate 8 years

• Frequency of TEAEs

  Approximate 8 years

• Seriousness of TEAEs

  Approximate 8 years

• Outcome of TEAEs

  Approximate 8 years

• Causality assessment of TEAEs

  Approximate 8 years

Secondary Outcomes (15)

• 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

  Approximate 8 years

• Disease control rate (DCR)

  Approximate 8 years

• Duration of response (DOR)

  Approximate 8 years

• Time to response (TTR)

  Approximate 8 years

• Progression-free survival (PFS)

  Approximate 8 years

Study Arms (8)

Gastrointestinal (GI)

Participants with GI cancer.

Drug: Larotrectinib (Vitrakvi, BAY2757556)

Head and neck (H&N)

Participants with H\&N cancer.

Drug: Larotrectinib (Vitrakvi, BAY2757556)

Lung

Participants with lung cancer.

Drug: Larotrectinib (Vitrakvi, BAY2757556)

Soft tissue sarcoma (STS)

Participants with STS cancer.

Drug: Larotrectinib (Vitrakvi, BAY2757556)

Primary central nervous system (CNS)

Participants with CNS cancer.

Drug: Larotrectinib (Vitrakvi, BAY2757556)

Melanoma

Participants with Melanoma cancer.

Drug: Larotrectinib (Vitrakvi, BAY2757556)

Pediatrics

Drug: Larotrectinib (Vitrakvi, BAY2757556)

Others

Drug: Larotrectinib (Vitrakvi, BAY2757556)

Interventions

Larotrectinib (Vitrakvi, BAY2757556) DRUG

Follow clinical practice

Gastrointestinal (GI); Head and neck (H&N); Lung; Melanoma; Others; Pediatrics; Primary central nervous system (CNS); Soft tissue sarcoma (STS)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult and pediatric (from birth to 18 year old) patients treated with larotrectinib.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many locations

Multiple Locations, Japan

RECRUITING

MeSH Terms

Interventions

larotrectinib

Central Study Contacts

Bayer Clinical Trials Contact

CONTACT

(+)1-888-84 22937; clinical-trials-contact@bayer.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2021
• First Posted: June 30, 2021
• Study Start: November 5, 2021
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)