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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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02122913
Enrollment
75
Registered
2014-04-25
Start date
2014-05-04
Completion date
2021-04-09
Last updated
2026-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumors Harboring NTRK Fusion

Keywords

Advanced solid tumors, Neurotrophic tyrosine receptor kinase (NTRK), NTRK1, NTRK2, NTRK3, Fusion Positive, TRK fusion, TRKA, TRKB, TRKC, ETV6

Brief summary

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.

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.

Interventions

DRUGLarotrectinib (Vitrakvi, BAY2757556)

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

Sponsors

Bayer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Severity of adverse events25 monthsThe severity of adverse events will be assesssed according to the NCI CTCAE version 4.03.
Maximum tolerated dose (MTD)25 months—
Recommended dose for dose expansion25 months—
Number of participants with adverse events25 months—

Secondary

MeasureTime frameDescription
Overall Response Rate (ORR)Up to 60 monthsAssessed using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Response Assessment in Neuro-Oncology (RANO) as appropriate
Maximum concentration of larotrectinib in plasma (Cmax)Predose and 0.25, 0.5, 1, 2, 4, 6 and 8 hours after drug administration on Days 1 and 8 of Cycle 1—
Duration of Response (DOR)Up to 60 months—
Time to maximum concentration of larotrectinib in plasma (Tmax)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)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)Predose and 0.25, 0.5, 1, 2, 4, 6 and 8 hours after drug administration on Days 1 and 8 of Cycle 1—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 29, 2026