Trial Condition(s):

Solid tumors harboring NTRK fusion

A study to test the safety of the investigational drug selitrectinib in children and adults that may treat cancer

Bayer Identifier:

20810

ClinicalTrials.gov Identifier:

NCT03215511

EudraCT Number:

2017-004246-20

Recruitment Complete

Trial Purpose

This research study is done to test the safety of the new drug selitrectinib in children and adults with cancer having a change in a particular gene (NTRK1, NTRK2 or NTRK3). The drug may treat cancer by interfering with the effect of the NTRK genes on cancer growth. The study also investigates how the drug is absorbed and processed in the human body, and how well and for how long the cancer responds to the drug. This is the first study to test selitrectinib in humans with cancer, for whom no other effective therapy exists.

Inclusion Criteria
- Advanced solid tumor for which, in the opinion of the investigator, no other standard therapy offers greater benefit.
  - A solid tumor diagnosis in the setting of:
  --- a) a documented NTRK fusion and a clinical history of relapse following a response to a prior TRK inhibitor  
  --- b) a documented NTRK fusion unresponsive to a prior TRK inhibitor
  --- c) a documented NTRK fusion and a clinical history of intolerance to a prior TRK inhibitor
  - NTRK gene fusions will be identified in a CLIA-certified (or equivalently-accredited diagnostic) laboratory. If such a report cannot be provided, other available certifications/accreditations are required and need to be documented. Patients with infantile fibrosarcoma (IFS) or congenital mesoblastic nephroma (CMN) may be enrolled based on an ETV6+ FISH test without identifying NTRK3.
  - Performance Status: Eastern Cooperative Oncology Group (ECOG) score ≤ 2 in adults or Karnofsky Performance Status (KPS) Score≥50%  (age ≥ 16 years) or Lansky Performance Score (LPS) ≥ 40% (age < 16 years).
  - Life expectancy of at least 3 months.
  - Adequate hematologic, hepatic and renal function.
  - Patients with stable central nervous system (CNS) primary tumor, brain metastases, or treated spinal cord compression are eligible if neurological symptoms have been stable for 7 days prior to the first dose of selitrectinib.
  - Ability to receive study drug orally or by enteral administration
Exclusion Criteria
- Prior exposure to second generation TRK inhibitor (e.g. selitrectinib, repotrectinib [TPX-0005]), taletrectinib [DS-6501b/AB-106]). Exception is in case patient presented intolerance to the second generation TRK inhibitor agent and the duration of exposure was less than 28 days. No previous treatment with selitrectinib is allowed.
  - Concurrent treatment with a strong CYP3A4 inhibitor or inducer, consumption of grapefruit juice or Seville oranges, or drugs associated with QT prolongation.
  - Clinically significant active cardiovascular disease or history of myocardial infarction within 3 months prior to planned start of selitrectinib, or prolongation of QT interval corrected for heart rate (QTc interval) >480 milliseconds within past 6 months
  - Major surgery within 7 days of enrollment
  - Uncontrolled systemic bacterial, fungal or viral infection.
  - Pregnancy or lactation.
  - Known hypersensitivity to selitrectinib or Ora-Sweet® SF and OraPlus® for patients receiving liquid formulation.

Trial Summary

Enrollment Goal
81
Trial Dates
black-arrow
Phase
1
Could I receive a placebo?
No
Products
selitrectinib (LOXO-195, BAY2731954)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

University of Texas MD Anderson Cancer Center

Houston, United States, 77030-4000

Status
Active, not recruiting
 
Locations

Stanford Cancer Center

Palo Alto, United States, 94304

Status
Active, not recruiting
 
Locations

Massachusetts General Hospital

Boston, United States, 02114-2696

Status
Completed
 
Locations

Oregon Health and Science University

Portland, United States, 97239

Status
Active, not recruiting
 
Locations

UCLA Jonsson Comprehensive Cancer Center

Los Angeles, United States, 90095

Status
Active, not recruiting
 
Locations

Dana-Farber Cancer Institute

Boston, United States, 02215

Status
Completed
 
Locations

St. Jude Children's Research Hospital

Memphis, United States, 38105

Status
Active, not recruiting
 
Locations

University of Michigan

Ann Arbor, United States, 48109

Status
Active, not recruiting
 
Locations

Children's Hospital of Philadelphia

Philadelphia, United States, 19104

Status
Completed
 
Locations

Seattle Children's Hospital

Seattle, United States, 98105

Status
Completed
 
Locations

Sarah Cannon Research Institute

Nashville, United States, 37203

Status
Completed
 
Locations

Virginia Oncology Associates

Norfolk, United States, 23502

Status
Completed
 
Locations

Univ.of California-San Diego Moores Cancer Center

La Jolla, United States, 92093

Status
Completed
 
Locations

Midwestern Regional Medical Center

Zion, United States, 60099

Status
Active, not recruiting
 
Locations

Fondazione IRCCS Istituto Nazionale dei Tumori

Milano, Italy, 20133

Status
Completed
 
Locations

Institut Curie - Ulm - Paris

PARIS, France, 75005

Status
Active, not recruiting
 
Locations

Institut Gustave Roussy

VILLEJUIF, France, 94805

Status
Active, not recruiting
 
Locations

Finsen Centre

Copenhagen, Denmark, 2100

Status
Active, not recruiting
 
Locations

Universitätsklinikum Heidelberg

Heidelberg, Germany, 69120

Status
Completed
 
Locations

Ciutat Sanitaria i Universitaria de la Vall d'Hebron

Barcelona, Spain, 08023

Status
Completed
 
Locations

Fundacion Jimenez Diaz (Clinica de la Concepcion)

Madrid, Spain, 28040

Status
Active, not recruiting
 
Locations

Sydney Children’s Hospital

Sydney, Australia, 2031

Status
Completed
 
Locations

National Cancer Center Singapore

Singapore, Singapore, 169610

Status
Completed
 
Locations

Avera Cancer Institute

Sioux Falls, United States, 57105

Status
Completed
 
Locations

UZ Antwerpen

EDEGEM, Belgium, 2650

Status
Active, not recruiting
 
Locations

Tallaght Hospital

Dublin, Ireland, 24

Status
Completed
 
Locations

Children's Healthcare of Atlanta

Atlanta, United States, 30329

Status
Completed
 
Locations

Royal Children's Hospital Melbourne

Parkville, Australia, 3052

Status
Active, not recruiting
 
Locations

Memorial Sloan-Kettering Cancer Center

New York, United States, 10065

Status
Active, not recruiting
 

Trial Design