Trial Condition(s):

Solid tumors harboring NTRK fusion

A study to test the safety of the investigational drug larotrectinib in adults that may treat cancer

Bayer Identifier:

20288

ClinicalTrials.gov Identifier:

NCT02122913

EudraCT Number:

Not Available

Study Completed

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.

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
75
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Vitrakvi (Larotrectinib, BAY2757556)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Massachusetts General Hospital

Boston, United States, 02114

Status
Completed
 
Locations

University of Pennsylvania

Philadelphia, United States, 19104

Status
Completed
 
Locations

Sarah Cannon Research Institute

Nashville, United States, 37203

Status
Completed
 
Locations

University of Colorado

Aurora, United States, 80045

Status
Completed
 
Locations

University Hospitals Cleveland Medical Center

Cleveland, United States, 44106

Status
Completed
 
Locations

University of Texas MD Anderson Cancer Center

Houston, United States, 77030

Status
Completed
 
Locations

Oregon Health and Science University

Portland, United States, 97239

Status
Completed
 
Locations

University of Pittsburgh

Pittsburgh, United States, 15232

Status
Completed
 

Trial Design