Phase 3 Study of Pexidartinib for Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCT-TS)

PHASE3CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

May 11, 2015

Primary Completion Date

March 27, 2017

Study Completion Date

April 30, 2021

Conditions
Pigmented Villonodular SynovitisGiant Cell Tumors of the Tendon SheathTenosynovial Giant Cell Tumor
Interventions
DRUG

Pexidartinib

Each capsule contains 200 mg of pexidartinib for oral administration

DRUG

Placebo

Placebo capsule matching pexidartinib capsule for oral administration

Trial Locations (39)

2050

Chris O'Brien Lifehouse, Sydney

2730

Herlev Hospital, Herlev

3000

Peter MacCallum Cancer Centre, East Melbourne

4102

Princess Alexandra Hospital, Woolloongabba

10065

Memorial Sloan Kettering Cancer Center, New York

13125

HELIOS Klinikum Berlin-Buch, Berlin

20133

Istituto Nazionale Tumori-Fondazione IRCCS, Milan

27710

Duke Cancer Center, Durham

32224

Mayo Clinic Cancer Center, Jacksonville

33136

Sylvester Comprehensive Cancer Center, Miami

33612

Moffitt Cancer Center, Tampa

37232

Vanderbilt-Ingram Cancer Center, Nashville

40136

Istituto Ortopedico Rizzoli, Bologna

41013

Hospital Universitario Virgen del Rocío, Seville

45147

Universitätsklinikum Essen, Essen

48109

Michigan Comprehensive Cancer Center, Ann Arbor

55905

Mayo Clinic Cancer Center, Rochester

63110

Washington University School of Medicine, St Louis

69373

Centre Leon Bérard, Lyon

84112

Huntsman Cancer Institute, Salt Lake City

90033

University of Southern California, Los Angeles

90404

UCLA Medical Center, Santa Monica

94305

Stanford Cancer Center, Palo Alto

94800

Institut Gustave Roussy, Villejuif

97239

OHSU Knight Cancer Institute, Portland

98109

Seattle Cancer Care Alliance, Seattle

85259-5499

Mayo Clinic, Scottsdale

02114

Massachusetts General Hospital, Boston

02115

: Dana Farber Cancer Institute, Boston

08103

MD Anderson Cancer Center at Cooper, Camden

M5G2M9

Princess Margaret Hospital, Toronto

H4A3J1

McGill University Health Centre, Montreal

H1134

Military Hospital-State Health Center, Budapest

2333 ZA

Leiden University Medical Center, Leiden

6525 GA

Radboud Univ. Medical Center, Nijmegen

02-781

Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie, Warsaw

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

NW12BU

University College Hospital, London

SW36JJ

The Royal Marsden NHS Foundation Trust, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Daiichi Sankyo

INDUSTRY