A Study to Test the Safety and Efficacy of the Drug Larotrectinib for the Treatment of Tumors With NTRK-fusion in Children

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

154

Participants

Timeline

Start Date

December 16, 2015

Primary Completion Date

July 20, 2024

Study Completion Date

September 30, 2026

Conditions
Solid Tumors Harboring NTRK Fusion
Interventions
DRUG

Larotrectinib (Vitrakvi, BAY2757556)

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

Trial Locations (45)

12

Children's Health Ireland Crumlin, Crumlin

2031

Sydney Children's Hospital, Sydney

2100

Rigshospitalet - Børn og Unge, Copenhagen

3052

Royal Children's Hospital Melbourne, Parkville

3080

Seoul National University Hospital, Seoul

5006

Women's and Children's Hospital, North Adelaide

8032

Universitätskinderspital Zürich, Zurich

10065

Memorial Sloan Kettering Cancer Center New York - Main Campus, New York

13353

Charité - Campus Virchow-Klinikum (CVK), Klinik für Pädiatrie mit Schwerpunkt Onkologie und Hämatologie, Berlin

19104

Children's Hospital of Philadelphia - Hematology/Oncology, Philadelphia

20133

Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Pediatria Oncologica, Milan

32827

Nemours Children's Hospital - Florida - Hematology / Oncology, Orlando

34093

Istanbul Universitesi Istanbul Tip Fakultesi, Istanbul

38105

St. Jude Children's Research Hospital, Memphis

75248

Institut Curie - Ulm - Paris, Paris

75390

University of Texas Southwestern Medical Center, Dallas

79035

Western Ukrainian Specialized Pediatric Medial Centre, Surgical Department, Lviv

90027

Children's Hospital Los Angeles - Hematology/Oncology, Los Angeles

94304

Lucille Packard Children's Hospital Stanford - Pediatric Nephrology, Palo Alto

94805

Gustave Roussy - Departement Oncologie-Radiotherapie, Villejuif

98105

Seattle Children's Hosptial - Oncology, Seattle

100045

Beijing Children's Hospital, Capital Medical University, Beijing

300000

Tianjin Medical University Cancer Institute & Hospital, Tianjin

510000

Sun Yat-sen University Cancer Center, Guangzhou

4920235

Clalit Health Services Schneider Children's Medical Center, Petah Tikva

90095-1781

UCLA Jonsson Comprehensive Cancer Center, Los Angeles

02215

Dana-Farber Cancer Institute, Boston

Ohio

"Cincinnati Children's Hospital Medical Center , Division of Nephrology and Hypertension"

V6H 3N1

BC Children's Hospital - Hematology/Oncology, Vancouver

M5G 1X8

The Hospital for Sick Children (SickKids), Toronto

H3T 1C5

CHU Sainte-Justine, Montreal

613 00

FN Brno - Detska nemocnice, Brno

150 06

Fakultni nemocnice v Motole, Prague

Baden-Wurttemberg

"Universitaetsklinikum Heidelberg - KiTZ , Klinik für Paediatrische Onkologie, Haematologie, Immunologie und Pneumologie"

"KLINIKUM STUTTGART - Olgahospital , Paediatrie 5 (Onkologie, Haematologie, Immunologie)"

252-8555

Kanagawa Children's Medical Center, Yokohama

104-0045

National Cancer Center Hospital, Chuo-ku

812-8582

Kyushu University Hospital, Fukuoka

3584 CS

Prinses Maxima Centrum, Utrecht

80-214

Uniwersyteckie Centrum Kliniczne, Gdansk

03722

Severance Hospital, Yonsei University Health System, Seoul

08035

Ciutat Sanitaria i Universitaria de la Vall d'Hebron, Barcelona

171 76

Karolinska Universitetssjukhuset i Solna, Stockholm

03022

"Governmental Noncommercial Institution National Cancer Institute", Kyiv

SM2 5PT

Royal Marsden NHS Trust (Surrey), Sutton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT02637687 - A Study to Test the Safety and Efficacy of the Drug Larotrectinib for the Treatment of Tumors With NTRK-fusion in Children | Biotech Hunter | Biotech Hunter