Study 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

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

Trial summary

Enrollment Goal

Trial Dates

May 2014 - April 2021

Phase

Phase 1

Could I Receive a placebo

Products

Vitrakvi (Larotrectinib, BAY2757556)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Massachusetts General Hospital	Boston, 02114, United States
Completed	University of Pennsylvania	Philadelphia, 19104, United States
Completed	Sarah Cannon Research Institute	Nashville, 37203, United States
Completed	University of Colorado	Aurora, 80045, United States
Completed	University Hospitals Cleveland Medical Center	Cleveland, 44106, United States
Completed	University of Texas MD Anderson Cancer Center	Houston, 77030, United States
Completed	Oregon Health and Science University	Portland, 97239, United States
Completed	University of Pittsburgh	Pittsburgh, 15232, United States

Primary Outcome

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 Outcome

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
Duration of Response (DOR)
Time 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