(Summit) a Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients with Indolent or Smoldering Systemic Mastocytosis

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

207

Participants

Timeline

Start Date

June 27, 2022

Primary Completion Date

September 30, 2025

Study Completion Date

April 30, 2030

Conditions
SSMMastocytosis, IndolentMastocytosis, SystemicMastocytosisISMBMMSmoldering Systemic MastocytosisBone Marrow Mastocytosis
Interventions
DRUG

Bezuclastinib Tablets (Formulation A)

Bezuclastinib will be administered orally, once daily continuously for 28-day cycles

DRUG

Bezuclastinib Tablets (Formulation B)

Bezuclastinib will be administered orally, once daily continuously for 28-day cycles

DRUG

Placebo Tablets

Placebo will be administered orally, once daily continuously for 28-day cycles

Trial Locations (69)

168

Policlinico Universitario Agostino Gemelli, Rome

2050

Royal Prince Alfred Hospital, Camperdown

2650

Antwerp University Hospital (UZA), Edegem

4031

University Hospital Basel, Basel

5000

Royal Adelaide Hospital, Adelaide

9713

University Medical Center Groningen, Groningen

10029

Icahn School of Medicine at Mount Sinai, New York

12203

Charité Universitätsmedizin Berlin, Berlin

20769

Allervie Clinical Research, Glenn Dale

20814

Walter Reed National Military Medical Center, Bethesda

20902

Institute for Asthma and Allergy, Wheaton

21162

Chesapeake Research Center, White Marsh

27100

Fondazione IRCCS Policlinico San Matteo, Pavia

27705

Duke University, Raleigh

28046

Hospital Universitario Ramon y Cajal, Madrid

29425

Medical University of South Carolina, Charleston

30322

Emory University, Atlanta

31400

CHU de Toulouse - Hopital Larrey, Toulouse

32224

Mayo Clinic - Jacksonville, Jacksonville

33612

University of South Florida, Tampa

33756

Innovative Research of West Florida, Clearwater

35233

University of Alabama at Birmingham, Birmingham

37235

Vanderbilt University Medical Center, Nashville

40138

IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola, Bologna

43210

The Ohio State University, Columbus

45221

University of Cincinnati, Cincinnati

48109

University of Michigan, Ann Arbor

52074

Universitaetsklinikum Aachen, AoeR, Aachen

55905

Mayo Clinic- Rochester, Rochester

60612

Rush University, Chicago

63110

Washington University at St. Louis, St Louis

68167

University Medical Centre Mannheim, Mannheim

75013

AP-HP- Hopital Pitie-Salpetriere, Paris

75231

AIR Care, Dallas

77030

The University of Texas MD Anderson Cancer Center, Houston

84119

Metrodora Institute of Technology, West Valley City

85054

Mayo Clinic Arizona, Phoenix

85258

One of a Kind Clinical Research Center, Scottsdale

90095

University of California, Los Angeles (UCLA) - Medical Center, Los Angeles

92037

Modena Allergy and Asthma Clinical, La Jolla

02115

Brigham and Women's Hospital, Boston

02215

Dana Farber Cancer Institute, Boston

03766

Dartmouth Hitchcock Medical Center, Lebanon

Unknown

Kepler Universitaetsklinikum GmbH, Linz

Medizinische Universitaet Wien, Vienna

CHU Tivoli, La Louvière

St. Michael's Hospital, Toronto

McGill University, Montreal

Fakultni nemocnice Kralovske Vinohrady, Prague

AP-HM - Hopital de la Timone, Marseille

Universitaetsklinikum Hamburg-Eppendorf, Hamburg

Universitätsklinikum Schleswig-Holstein, Kiel

Attikon University General Hospital Athens, Athens

Cork University Hospital, Cork

AOU Policlinico Rodolico San Marco, Catania

Azienda Ospedaliero-Universitaria Careggi, Florence

AUSL della Romagna-Ospedale S.Maria delle Croci, Ravenna

Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento, Verona

Erasmus Rotterdam, Rotterdam

Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii, Gdansk

Samodzielny Publiczny Szpital Kliniczny Nr 1 - Klinika Hematoonkologii i Transplantacji Szpiku, Lublin

Institut Catala d'Oncologia - L'Hospitalet, Barcelona

Instituto de Estudios de Mastocitosis de Castilla La Mancha-Hospital Virgen del Valle, Toledo

T2N 4N2

Tom Baker Cancer Centre, Calgary

T6G 2R3

University of Alberta, Edmonton

D08 NHY1

St. James's Hospital, Dublin

0424

Oslo University Hospital, Oslo

08035

Hospital Universitario Vall d'Hebron, Barcelona

SE1 9RT

Guy's Hospital, London

Sponsors
All Listed Sponsors
lead

Cogent Biosciences, Inc.

INDUSTRY