701
Participants
Start Date
December 8, 2022
Primary Completion Date
June 30, 2025
Study Completion Date
December 31, 2026
Gedatolisib
Gedatolisib 180 mg IV given weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off
Palbociclib
Palbociclib 125 mg PO given daily for 3 weeks (21 days), followed by 1 week off
Fulvestrant
Fulvestrant 500 mg IM (2 × 5 mL injections) given every 2 weeks during Cycle 1 (Days 1 and 15), then every 4 weeks beginning with Cycle 2 Day 1
Alpelisib
Alpelisib 300 mg PO (2 × 150 mg tablets) given daily for 4 weeks (28 days)
RECRUITING
Weill Cornell Medicine/New York-Presbyterian Hospital, New York
RECRUITING
Montefiore Medical Center, The Bronx
RECRUITING
White Plains Hospital, White Plains
RECRUITING
Queens Hospital Cancer Center, Jamaica
RECRUITING
New York Oncology Hematology, P.C. - Albany, Albany
RECRUITING
Hematology/Oncology Associates of Central New York, Syracuse
RECRUITING
Francois Baclesse Center, Caen
NOT_YET_RECRUITING
University of Rochester Medical Center, Rochester
COMPLETED
Cancer Care Associates of York, York
COMPLETED
Consultants In Medical Oncology and Hematology, P.C., Broomall
RECRUITING
Alliance Cancer Specialists PC, Horsham
RECRUITING
Maryland Oncology Hematology, P.A. - Rockville, Rockville
RECRUITING
Fort Belvoir Community Hospital, Fort Belvoir
RECRUITING
Bon Secours St. Francis Medical Oncology Center, Midlothian
RECRUITING
VCU Massey Cancer Center, Richmond
RECRUITING
Virginia Oncology Associates - Newport News, Newport News
RECRUITING
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care - Roanoke, Roanoke
RECRUITING
Cone Health Cancer Center at Alamance Regional, Hematology/Oncology, Greensboro
RECRUITING
Southeast Regional Cancer Center, Lumberton
RECRUITING
John D. Archbold Memorial Hospital, Thomasville
RECRUITING
Cancer Specialists of North Florida - Jacksonville, Jacksonville
RECRUITING
South Broward Hospital District d/b/a Memorial Healthcare System, Hollywood
RECRUITING
H. Lee Moffitt Cancer Center & Research Institute, Tampa
COMPLETED
Bond & Steele Clinic, P.A. d/b/a Bond Clinic, P.A., Winter Haven
RECRUITING
University of Alabama at Birmingham, Birmingham
RECRUITING
Mercy Health - Paducah, Paducah
RECRUITING
The James Cancer Hospital and Solove Research Institute, Columbus
RECRUITING
Fort Wayne Medical Oncology and Hematology, Fort Wayne
RECRUITING
Henry Ford Hospital, Detroit
RECRUITING
Sanford Gynecologic Oncology Clinic, Sioux Falls
RECRUITING
Illinois Cancer Specialists - Arlington Heights, Arlington Heights
RECRUITING
Filios High Medicine, Monterrey
RECRUITING
Oncology Hematology West PC dba Nebraska Cancer Specialists, Omaha
COMPLETED
University of Nebraska Medical Center, Omaha
RECRUITING
Nebraska Hematology - Oncology, P.C., Lincoln
RECRUITING
CARTI Cancer Center, Little Rock
RECRUITING
St. Bernards Medical Center, Jonesboro
RECRUITING
OU Health Stephenson Cancer Center, Oklahoma City
COMPLETED
Texas Oncology - McKinney, McKinney
COMPLETED
Texas Oncology P.A. - Dallas, Dallas
RECRUITING
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas
RECRUITING
Texas Oncology - Tyler, Tyler
RECRUITING
Oncology Consultants, Houston
RECRUITING
University of Texas MD Anderson Cancer Center, Houston
RECRUITING
Texas Oncology - Gulf Coast, Sugar Land
RECRUITING
Brooke Army Medical Center, Houston
RECRUITING
Texas Oncology - Austin, Austin
RECRUITING
William Beaumont Army Medical Center, El Paso
COMPLETED
Arizona Oncology (US Oncology/McKesson) - Goodyear, Goodyear
RECRUITING
La Roche-sur-Yon Hospital, La Roche-sur-Yon
RECRUITING
Torrance Memorial Physician Network - Cancer Care, Torrance
COMPLETED
Kaiser Permanente South Bay Medical Center, Harbor City
RECRUITING
Cancer and Blood Specialty Clinic, Los Alamitos
RECRUITING
UCLA Hematology/Oncology-Santa Monica, Santa Monica
RECRUITING
Redlands Hematology Oncology, Redlands
COMPLETED
Pacific Cancer Medical Center Inc, Anaheim
RECRUITING
University of California, Irvine Medical Center, Orange
COMPLETED
Ventura County Hematology Oncology Specialists, Oxnard
RECRUITING
Pacific Cancer Care, Monterey
RECRUITING
Kaiser Permanente Medical Center - Vallejo, Vallejo
COMPLETED
Northwest Cancer Specialists, PC - Tigard, Tigard
RECRUITING
Oregon Oncology Specialists, Salem
RECRUITING
Northwest Medical Specialties, PLLC - Tacoma, Tacoma
COMPLETED
PIH Health Hospital Whittier, Whittier
RECRUITING
Yale Cancer Center - New Haven, New Haven
RECRUITING
University of Kentucky Medical Center, Lexington
RECRUITING
American Oncology Partners of Maryland, PA, Bethesda
RECRUITING
Dana Farber Cancer Institute, Boston
RECRUITING
Beth Israel Deaconess Medical Center, Boston
RECRUITING
Coleman, Pasmantier & Decter, MDs, New York
RECRUITING
University Hospitals Cleveland Medical Center, Cleveland
RECRUITING
Fred Hutchinson Cancer Center, Seattle
RECRUITING
Alexander Fleming Institute, Buenos Aires
RECRUITING
Buenos Aires British Hospital, Buenos Aires
RECRUITING
CENIT Foundation, Buenos Aires
RECRUITING
Center for Medical Education and Clinical Research (CEMIC), Buenos Aires
RECRUITING
Fleischer Medical Center, Buenos Aires
RECRUITING
Medical Center Austral, Buenos Aires
NOT_YET_RECRUITING
Pergamino Clinic, Buenos Aires
RECRUITING
Cordoba Oncology Institute (IONC), Córdoba
RECRUITING
Center of Nuclear and Molecular Medicine of Entre Rios (CEMENER), Paraná
RECRUITING
CEDIT Diagnostic and treatment center, Salta
RECRUITING
CER San Juan, San Juan
RECRUITING
9 of July Sanatorium, San Miguel de Tucumán
RECRUITING
Rosario's Oncology Institute and Medical Specialities (IOR), Santa Fe
RECRUITING
Adelaide Oncology & Haematology, Adelaide
RECRUITING
St Vincent's Hospital (Melbourne) Ltd, Fitzroy
COMPLETED
Peninsula & South Eastern Hematology and Oncology Group (PSEHOG), Frankston
RECRUITING
Hollywood Private Hospital, Breast Cancer Research Centre, Nedlands
RECRUITING
Mater Hospital Brisbane, Mater Cancer Care Centre, South Brisbane
RECRUITING
Icon Cancer Centre- Southport, Southport
RECRUITING
Sydney Adventist Hospital, Wahroonga
RECRUITING
The Queen Elizabeth Hospital, Woodville
RECRUITING
University Hospital Graz, Department of Gynecology and Obstetrics, Graz
RECRUITING
University Hospital Innsbruck - Tyrolean Hospital, Department of Gynaecology and Obstetrics, Innsbruck
RECRUITING
Order Hospital Linz Ltd. - Hospital of Sisters of Mercy, Department of Internal Medicine I, Linz
RECRUITING
Salzburg Regional Hospital, Department of Internal Medicine III, Salzburg
RECRUITING
University Hospital St. Poelten, Department of Internal Medicine I, Sankt Pölten
RECRUITING
Hospital Hietzing, Department of Gynecology, Vienna
RECRUITING
Medical University Vienna, Department of Gynecology and Obstetrics, Vienna
RECRUITING
Saint Luc University Hospital, Brussels
RECRUITING
Charleroi Grand Hospital (GHDC), Charleroi
RECRUITING
University Hospital Antwerp (UZA), Edegem
RECRUITING
AZ Groeninge, Kortrijk
RECRUITING
University Hospitals Leuven, Campus Gasthuisberg, Leuven
RECRUITING
Citadelle Regional Hospital Center, Liège
RECRUITING
VITAZ, Sint-Niklaas
RECRUITING
Centre Hospitalier Peltzer-la-Tourelle, Verviers
RECRUITING
UCL Mont-Godinne University Hospitals, Yvoir
RECRUITING
Oncology Treatment Center, Belém
RECRUITING
Pronutrir, Fortaleza
RECRUITING
ONCOSITE - Clinical Research Center in Oncology, Ijuí
RECRUITING
Juiz de Fora Eurolatino Research Center, Minas Gerais
RECRUITING
Bahia Oncology Center, Salvador
RECRUITING
D'OR Institute, São Paulo
RECRUITING
Hospital A.C.Camargo, São Paulo
RECRUITING
Multiprofile Hospital for Active Treatment - Uni Hospital, Panagyurishte, Panagyurishte
RECRUITING
"MHAT for Women's Health Nadezhda", Sofia
RECRUITING
"Multiprofile Hospital for Active Treatment Serdika, Sofia", Sofia
RECRUITING
Specialized Hospital for Active Treatment in Oncology, Clinic of Medicial Oncology (Chemotherapy), Sofia
RECRUITING
"University Multiprofile Hospital for Active Treatment Sveta Marina", Varna
NOT_YET_RECRUITING
BC Cancer - Vancouver, Medical Oncology, Vancouver
RECRUITING
CIUSSS du Saguenay Lac St-Jean, Chicoutimi
NOT_YET_RECRUITING
Hospital Notre-Dame, Montreal
RECRUITING
Maisonneuve-Rosemont Hospital, Montreal
RECRUITING
University Hospital Olomouc, Clinic of Oncology, Olomouc
RECRUITING
Thomayer University Hospital, Clinic of Oncology, Prague
RECRUITING
University Hospital Bulovka, Institute of Radiation Oncology, Prague
RECRUITING
University Hospital Motol, Clinic of Oncology, Prague
RECRUITING
Bergonie Institute, Bordeaux
RECRUITING
CHU La Timone - La Timone Children's Hospital, Marseille
RECRUITING
University Hospital Center of Poitiers, Poitiers
RECRUITING
Saint Anne Clinic, Strasbourg
RECRUITING
Gustave Roussy, Villejuif
RECRUITING
Hospital Bayreuth, Bayreuth
RECRUITING
Vivantes Hospital Am Urban, Berlin
RECRUITING
Hospital Suedstadt Rostock, Dorf Mecklenburg
RECRUITING
Private Practice with Focus on Oncology, Lübeck
RECRUITING
University Hospital Johannes Gutenberg - University of Mainz, Mainz
RECRUITING
University Hospital Muenster, Münster
RECRUITING
Caritas Klinikum, Saarbrücken
RECRUITING
Helios Clinic Wuppertal, Wuppertal
RECRUITING
Alexandra General Hospital, Athens
RECRUITING
University General Hospital of Ioannina, Ioannina
RECRUITING
IASO Thessaly SA, Larissa
RECRUITING
EUROMEDICA General Clinic of Thessaloniki, Thessaloniki
RECRUITING
Theageneio Anticancer Hospital of Thessaloniki, Thessaloniki
RECRUITING
University of Debrecen Clinical Center, Institute of Oncology, Debrecen
RECRUITING
Bacs-Kiskun County Hospital, Center for Oncoradiology, Kecskemét
RECRUITING
Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital, Department of Oncology, Nyíregyháza
NOT_YET_RECRUITING
HCG Cancer Centre, Bangalore
NOT_YET_RECRUITING
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
COMPLETED
Tata Medical Center, Kolkata
COMPLETED
Tata Memorial Hospital, Navi Mumbai
NOT_YET_RECRUITING
Christian Medical College, Department of Medical Oncology, Vellore
RECRUITING
European Institute of Oncology (IEO), IRCCS, Milan
RECRUITING
University Polyclinic Hospital of Modena, Modena
RECRUITING
Local Healthcare Company of Monza (ASST Monza), Monza
RECRUITING
University Hospital of Parma, Parma
RECRUITING
New Hospital of Prato (NOP), Prato
RECRUITING
University Hospital Campus Bio-Medico, Rome
RECRUITING
"University Polyclinic Foundation Agostino Gemelli - IRCCS", Rome
RECRUITING
Santa Maria della Misericordia University Hospital of Udine, Udine
RECRUITING
Clinical Research Center Chapultepec Mexico City, Mexico City
RECRUITING
CRYPTEX, Mexico City
RECRUITING
ProcliniQ Clinical Research, Mexico City
RECRUITING
Administrative Society of Health Services, SC, Morelia
RECRUITING
Avix Clinical Research, Nuevo León
RECRUITING
Zambrano Hellion Medical Center, Nuevo León
COMPLETED
Inbiomedyc, Querétaro
RECRUITING
ONCOR Life Medical Center, Saltillo
RECRUITING
Prof. Franciszek Lukaszczyk Oncology Center in Bydgoszcz, Chemotherapy Outpatient Clinic, Bydgoszcz
RECRUITING
"Medical Clinic Komed", Konin
RECRUITING
Maria Sklodowska-Curie Institute of Oncology, Branch in Krakow, Krakow
RECRUITING
Polish Mother's Memorial Hospital-Research Institute, Lodz
RECRUITING
Independent Public Healthcare Facility Prof. Tadeusz Koszarowski Opole Oncology Center in Opole, Clinical Oncology Department and Day Hospitalization Unit, Opole
RECRUITING
St. John Paul 2nd Mazovian Provincial Hospital in Siedlce Limited Liability Company, Siedlce Oncology Centre, Siedlce
RECRUITING
West Pomeranian Oncology Center, Szczecin
RECRUITING
LUX MED Oncology LLC, Szamocka Hospital, Department of Clinical Oncology/Chemotherapy, Warsaw
RECRUITING
Maria Sklodowska-Curie - National Research Institute of Oncology, Warsaw
RECRUITING
Provincial Specialist Hospital in Wroclaw, Department of Chemotherapy, Wroclaw
RECRUITING
S.C. Oncopremium-Team SRL, Baia Mare
RECRUITING
Prof. Dr. Alexandru Trestioreanu Institute of Oncology, Bucharest
COMPLETED
Prof. Dr. Ion Chiricuta Institute of Oncology, Cluj-Napoca
RECRUITING
Onco Clinic Consult S.A., Craiova
RECRUITING
"Oncology Center Sf. Nectarie", Craiova
RECRUITING
S.C. Topmed Medical Center SRL, Târgu Mureş
RECRUITING
Curie Oncology, Singapore
RECRUITING
ICON SOC Farrer Park Medical Clinic, Singapore
RECRUITING
OncoCare Cancer Centre, Singapore
RECRUITING
Raffles Hospital, Singapore
RECRUITING
Tan Tock Seng Hospital, Singapore
RECRUITING
Asan Medical Center, Seoul
RECRUITING
Gangnam Severance Hospital, Soeul
RECRUITING
Korea University Anam Hospital, Soeul
RECRUITING
Samsung Medical Center, Soeul
RECRUITING
Severance Hospital, Yonsei University Health System, Soeul
RECRUITING
Ulsan University Hospital, Ulsan
RECRUITING
Infanta Cristina Hospital, Badajoz
RECRUITING
Catalan Institute of Oncology, Hospital Duran i Reynals, Barcelona
RECRUITING
Caceres Hospital Complex - San Pedro de Alcantara General Hospital, Cáceres
RECRUITING
Hospital Ruber Internacional, Madrid
RECRUITING
University Hospital Foundation Jimenez Diaz, Madrid
RECRUITING
University Clinical Hospital Virgen de la Arrixaca, Department of Oncology, Murcia
RECRUITING
University Hospital Complex of Santiago (CHUS), Department of Oncology, Santiago de Compostela
RECRUITING
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City
NOT_YET_RECRUITING
Taipei Medical University - Shuang Ho Hospital, New Taipei City
NOT_YET_RECRUITING
China Medical University Hospital, Taichung
RECRUITING
National Cheng Kung University Hospital, Tainan City
RECRUITING
National Taiwan University Hospital, Taipei
NOT_YET_RECRUITING
Taipei Veterans General Hospital, Taipei
NOT_YET_RECRUITING
Royal United Hospital, Department of Oncology/Hematology, Bath
NOT_YET_RECRUITING
Velindre Cancer Centre, Cardiff
NOT_YET_RECRUITING
Guy's Hospital, London
NOT_YET_RECRUITING
Royal Marsden Hospital - London, Department of Medical Oncology, London
NOT_YET_RECRUITING
The Christie NHS Foundation Trust, Manchester
NOT_YET_RECRUITING
Nottingham City Hospital, Nottingham
Lead Sponsor
Celcuity Inc
INDUSTRY