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

Bayer75 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Tumors Harboring NTRK Fusion

Interventions

Larotrectinib (Vitrakvi, BAY2757556)DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

UCHealth Cancer Center - Anschutz Medical Campus - University of Colorado Cancer Center

Aurora, Colorado, United States

Mass General Cancer Center

Boston, Massachusetts, United States

UH Seidman Cancer Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Number of participants with adverse events

Time frame: 25 months

Severity of adverse events

The severity of adverse events will be assesssed according to the NCI CTCAE version 4.03.

Time frame: 25 months

Maximum tolerated dose (MTD)

Time frame: 25 months

Recommended dose for dose expansion

Time frame: 25 months

Secondary Outcomes

Maximum concentration of larotrectinib in plasma (Cmax)

Time frame: Predose and 0.25, 0.5, 1, 2, 4, 6 and 8 hours after drug administration on Days 1 and 8 of Cycle 1

Time to maximum concentration of larotrectinib in plasma (Tmax)

Time frame: Predose and 0.25, 0.5, 1, 2, 4, 6 and 8 hours after drug administration on Days 1 and 8 of Cycle 1

Half-life of larotrectinib in plasma (t1/2)

Time frame: Predose and 0.25, 0.5, 1, 2, 4, 6 and 8 hours after drug administration on Days 1 and 8 of Cycle 1

Area under the concentration versus time curve of larotrectinib in plasma (AUC)

Time frame: Predose and 0.25, 0.5, 1, 2, 4, 6 and 8 hours after drug administration on Days 1 and 8 of Cycle 1

Overall Response Rate (ORR)

Assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Response Assessment in Neuro-Oncology (RANO) as appropriate

Time frame: Up to 60 months

Data from ClinicalTrials.gov

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