Larotrectinib in Adults and Children With NTRK-fusion Positive Solid Tumors

A Study to Test the Effect of the Drug Larotrectinib in Adults and Children With NTRK-fusion Positive Solid Tumors.

Agents: BAY2757556 (Larotrectinib, Vitrakvi)
Phase II
Status Recruiting
Sponsor Bayer

For further information please also consult ClinicalTrials.gov.

 

This is a Phase II study to test how well different types of cancer respond to the drug called larotrectinib. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib is a drug that blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer.

WHO is the trial for?
  • Locally-advanced or metastatic malignancy with an NTRK1, NTRK2, or NTRK3 gene fusion
    identified in CLIA-certified laboratory.
  • Already received prior standard therapy, but are unlikely to benefit from it.
  • At least one measurable lesion per RECIST v1.1. For primary CNS tumors,
    additional criteria apply.
  • At least 18 years of age.
  • Overall health of the patients must be good -  ECOG score ≤ 3
    (KPS ≥ 50% for primary CNS tumor with RANO assessment).
  • For subjects eligible for enrollment to bone health cohort only:
    life expectancy of at least 6 months, based on investigator assessment.

WHAT is the key question that this trial is attempting to answer?

 The primary objective of this study is to investigate the efficacy of larotrectinib for the treatment
of advanced solid tumors harboring a fusion of neurotrophic tyrosine receptor kinase (NTRK)
of types 1-3 in children and adults.Secondary objectives comprise the efficacy and safety of larotrectinib in different NTRK-tumor types.

WHY patients might want to participate?

 This study evaluates the effectiveness of Larotrectinib, a drug designed to target specific cancer-related gene
mutations (NTRK1, NTRK2, or NTRK3). This clinical trial offers a tailored approach to treat cancer, potentially
providing patients with a more targeted and promising treatment option. Participating in the study could offer
hope for improved outcomes of other patients and maybe for themselves while contributing to the advancement
of cancer research.

WHEN will the trial be open?

 This study is open for recruitment.

WHERE is the trial available?

 The trial is being conducted in: Argentina,  Australia,  Belgium,  Brazil,  Canada,  China,  Colombia,  Czechia,  Denmark,  France,  Germany,  Greece,
Hungary,  India,  Ireland,  Italy,  Japan,  Korea, Republic of,  Norway,  Poland,  Portugal,  Russian Federation,  Singapore,  Slovakia,  Spain,  Sweden,  Taiwan,  Turkey,  Ukraine,  United Kingdom,  United States.
For further information please check here.

Contact: Bayer Clinical Trials by Phone Number:(+)1-888-84 22937 or
Email Address: clinical-trials-contact@bayer.com

STUDY DESIGN: What does the study look like?

 This research study is done to test how well different types of cancer respond to the drug called larotrectinib.
The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib is a drug that blocks
the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer.Larotrectinib will be administered orally as capsule or liquid solution at a dose of 100 mg twice daily
in continuing 28-days cycles.

 

HOW do I get more information?

  ClinicalTrials.gov, cancer societies or specific cancer-focused patient advocacy groups in your country may offer
additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient
organizations that might be helpful. If there are no such organization in your country, please email us for
more information: info@sarcoma-patients.org

 

Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

Merken