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NCT Number: NCT02122913

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.

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Key information

Conditions

Solid Tumors Harboring NTRK Fusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UCHealth Cancer Center - Anschutz Medical Campus - University of Colorado Cancer Center, Aurora, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Larotrectinib (Vitrakvi, BAY2757556)

Drug

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

Other names: LOXO-101

Primary outcomes

  1. Number of participants with adverse events

    Time frame: 25 months

  2. Severity of adverse events

    Time frame: 25 months

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

  3. Maximum tolerated dose (MTD)

    Time frame: 25 months

  4. Recommended dose for dose expansion

    Time frame: 25 months

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Overall Response Rate (ORR)

    Time frame: Up to 60 months

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

  6. Duration of Response (DOR)

    Time frame: Up to 60 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Phase 1 Study of the Oral TRK Inhibitor Larotrectinib in Adult Patients With Solid Tumors

Important dates

Study start
2014
Primary completion
2017
Study completion
2021
First posted
Apr 25, 2014
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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