check_circleStudy Completed

Solid tumors harboring NTRK fusion

Bayer Identifier:

20288

ClinicalTrials.gov Identifier:

NCT02122913

EudraCT Number:

Not Available

EU CT Number:

Not Available
A study to test the safety of the investigational drug larotrectinib in adults that may treat cancer

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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

  • - 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

Trial summary

Enrollment Goal
75
Trial Dates
May 2014 - April 2021
Phase
Phase 1
Could I Receive a placebo
No
Products
Vitrakvi (Larotrectinib, BAY2757556)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Massachusetts General HospitalBoston, 02114, United States
Completed
University of PennsylvaniaPhiladelphia, 19104, United States
Completed
Sarah Cannon Research InstituteNashville, 37203, United States
Completed
University of ColoradoAurora, 80045, United States
Completed
University Hospitals Cleveland Medical CenterCleveland, 44106, United States
Completed
University of Texas MD Anderson Cancer CenterHouston, 77030, United States
Completed
Oregon Health and Science UniversityPortland, 97239, United States
Completed
University of PittsburghPittsburgh, 15232, United States

Primary Outcome

  • Number of participants with adverse events
    date_rangeTime Frame:
    25 months
  • Severity of adverse events
    The severity of adverse events will be assesssed according to the NCI CTCAE version 4.03.
    date_rangeTime Frame:
    25 months
  • Maximum tolerated dose (MTD)
    date_rangeTime Frame:
    25 months
  • Recommended dose for dose expansion
    date_rangeTime Frame:
    25 months

Secondary Outcome

  • Maximum concentration of larotrectinib in plasma (Cmax)
    date_rangeTime 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)
    date_rangeTime 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)
    date_rangeTime 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)
    date_rangeTime 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
    date_rangeTime Frame:
    Up to 60 months
  • Duration of Response (DOR)
    date_rangeTime Frame:
    Up to 60 months

Trial design

A phase 1 study of the oral TRK inhibitor larotrectinib in adult patients with solid tumors
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Sequential Assignment
Trial Arms
7