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Purpose

This research study is done to test the safety of the drug larotrectinib in adult cancer patients. The drug may be used to treat cancer with a change in a particular gene (NTRK1, NTRK2 or NTRK3), because it blocks the action of these genes in cancer cells. The study also investigates how the drug is absorbed and processed in the human body. This is the first study to test larotrectinib in humans with cancer, for whom no other effective therapy exists.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adult patients with a locally advanced or metastatic solid tumor that has progressed or was nonresponsive to available therapies, are unfit for standard chemotherapy or for which no standard or available curative therapy exists - Proof of a malignancy harboring a NTRK fusion - Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2 and a life expectancy of at least 3 months - Adequate hematologic, hepatic, and renal function

Exclusion Criteria

  • Patients with unstable primary central-nervous-system tumors or metastasis, exceptions possible - Clinically significant active cardiovascular disease or history of myocardial infarction - Active uncontrolled systemic bacterial, viral, or fungal infection - Current treatment with a strong CYP3A4 inhibitor or inducer - Pregnancy or lactation

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Tumor patients_Dose 1 		Adult patients with solid tumors receiving 50 mg of BAY2757556 once daily (dose escalation cohort).
  • Drug: Larotrectinib (Vitrakvi, BAY2757556)
    BAY2757556 will be administered orally as capsule or in liquid form over continuous 28-day cycles.
    Other names:
    • LOXO-101
Experimental
Tumor patients_Dose 2 		Adult patients with solid tumors receiving 100 mg of BAY2757556 once daily (dose escalation cohort).
  • Drug: Larotrectinib (Vitrakvi, BAY2757556)
    BAY2757556 will be administered orally as capsule or in liquid form over continuous 28-day cycles.
    Other names:
    • LOXO-101
Experimental
Tumor patients_Dose 3 		Adult patients with solid tumors receiving 100 mg of BAY2757556 twice daily (dose escalation cohort).
  • Drug: Larotrectinib (Vitrakvi, BAY2757556)
    BAY2757556 will be administered orally as capsule or in liquid form over continuous 28-day cycles.
    Other names:
    • LOXO-101
Experimental
Tumor patients_Dose 4 		Adult patients with solid tumors receiving 200 mg of BAY2757556 once daily (dose escalation cohort).
  • Drug: Larotrectinib (Vitrakvi, BAY2757556)
    BAY2757556 will be administered orally as capsule or in liquid form over continuous 28-day cycles.
    Other names:
    • LOXO-101
Experimental
Tumor patients_Dose 5 		Adult patients with solid tumors receiving 150 mg of BAY2757556 twice daily (dose escalation cohort).
  • Drug: Larotrectinib (Vitrakvi, BAY2757556)
    BAY2757556 will be administered orally as capsule or in liquid form over continuous 28-day cycles.
    Other names:
    • LOXO-101
Experimental
Tumor patients_Dose 6 		Adult patients with solid tumors receiving 200 mg of BAY2757556 twice daily (dose escalation cohort).
  • Drug: Larotrectinib (Vitrakvi, BAY2757556)
    BAY2757556 will be administered orally as capsule or in liquid form over continuous 28-day cycles.
    Other names:
    • LOXO-101
Experimental
Tumor patients_Expansion 		Adults patients with solid tumors and neurotrophic tyrosine kinase (NTRK) genes or proteins of types 1 - 3 (dose expansion cohort). Patients receive either the recommended or maximum tolerated dose of BAY2757556 as determined in the dose escalation part.
  • Drug: Larotrectinib (Vitrakvi, BAY2757556)
    BAY2757556 will be administered orally as capsule or in liquid form over continuous 28-day cycles.
    Other names:
    • LOXO-101

More Details

Status
Completed
Sponsor
Bayer

Study Contact

Detailed Description

The trial will be conducted in 2 parts: an initial dose escalation phase of larotrectinib in subjects with advanced solid tumors will be followed by an expansion phase in subjects with solid tumors having a NTRK fusion. The objectives of the study are to determine the safety, pharmacokinetic profile, recommended dose and efficacy of orally administered larotrectinib in patients with NTRK fusions.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.