A Study to Test the Safety of the Investigational Drug Larotrectinib in Adults That May Treat Cancer

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.

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

Additional locations may be listed on ClinicalTrials.gov for NCT02122913.

See trial information on ClinicalTrials.gov for a list of participating sites.

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.

Trial PhasePhase I

Trial Typetreatment

Lead OrganizationBayer Corporation

Primary ID20288
Secondary IDsNCI-2014-02044, LOXO-TRK-14001
ClinicalTrials.gov IDNCT02122913

A Study to Test the Safety of the Investigational Drug Larotrectinib in Adults That May Treat Cancer

Inclusion Criteria

Exclusion Criteria

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A Study to Test the Safety of the Investigational Drug Larotrectinib in Adults That May Treat Cancer

Description

Eligibility Criteria

Locations & Contacts

Trial Objectives and Outline

Trial Phase & Type

Lead Organization

Trial IDs

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