Trial | NCT02122913  Report issue

Title

A Study to Test the Safety of the Investigational Drug Larotrectinib in Adults That May Treat Cancer
A Phase 1 Study of the Oral TRK Inhibitor Larotrectinib in Adult Patients With Solid Tumors

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    larotrectinib ...

  • Study Participants

    75
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.
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.
Study Started
May 04
2014
Primary Completion
Feb 01
2017
Study Completion
Apr 09
2021
Last Update
Nov 07
2023

Drug Larotrectinib (Vitrakvi, BAY2757556)

BAY2757556 will be administered orally as capsule or in liquid form over continuous 28-day cycles.

  • Other names: LOXO-101

Tumor patients_Dose 1 Experimental

Adult patients with solid tumors receiving 50 mg of BAY2757556 once daily (dose escalation cohort).

Tumor patients_Dose 2 Experimental

Adult patients with solid tumors receiving 100 mg of BAY2757556 once daily (dose escalation cohort).

Tumor patients_Dose 3 Experimental

Adult patients with solid tumors receiving 100 mg of BAY2757556 twice daily (dose escalation cohort).

Tumor patients_Dose 4 Experimental

Adult patients with solid tumors receiving 200 mg of BAY2757556 once daily (dose escalation cohort).

Tumor patients_Dose 5 Experimental

Adult patients with solid tumors receiving 150 mg of BAY2757556 twice daily (dose escalation cohort).

Tumor patients_Dose 6 Experimental

Adult patients with solid tumors receiving 200 mg of BAY2757556 twice daily (dose escalation cohort).

Tumor patients_Expansion Experimental

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.

Criteria 

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
No Results Posted