Clinical trial NCT05501886: Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)
Official title: Phase 3, Open-Label, Randomized, Study Comparing Gedatolisib Combined With Fulvestrant & With or Without Palbociclib to Standard-of-Care Therapies in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination w/Non-Steroidal Aromatase Inhibitor Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Breast Cancer, Advanced or Metastatic
gedatolisib
HR Positive
ER Positive
HER2 Negative
PIK3CA MT
PI3K
Lead sponsor: Celcuity Inc
Sponsor class: INDUSTRY
First posted: 2022-08-16
Enrollment: 701
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy.

Detailed description: This is a Phase 3, open-label, randomized clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with advanced (inoperable) or metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy. Gedatolisib is an intravenously administered pan-PI3K/mTOR inhibitor. Palbociclib is a CDK4/6 inhibitor. Fulvestrant is a selective estrogen receptor degrader (SERD). Subjects will be assessed for PIK3CA status and then randomized to treatment arms according to their confirmed PIK3CA mutation status.

Eligibility criteria: Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of metastatic or locally advanced breast cancer Adult females, pre- and/or post-menopausal, and adult males. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment with an LHRH agonist. Patients are to have commenced concomitant treatment with LHRH agonist prior to or on Cycle 1, Day 1 and must be willing to continue on it for the duration of the study.
2. Negative pregnancy test for women of childbearing potential. Female subjects of childbearing potential must use an effective and/or acceptable contraceptive method from screening until 1 year after the last dose of study treatment
3. Confirmed diagnosis of estrogen receptor positive and/or progesterone receptor positive, as per American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) guidelines (2020), based on most recent tumor biopsy utilizing an assay consistent with local standards
4. Documented HER2 immunohistochemistry (IHC) negative as per ASCO-CAP 2018 guidance
5. Adequate archival or fresh tumor tissue for the analysis of PIK3CA mutational status
6. Subject must have documentation of radiological disease progression on or after the last prior treatment and also have radiologically evaluable disease (measurable and/or non-measurable) according to RECIST v1.1, per local assessment. Subjects with bone only disease must have lytic or mixed lytic/blastic lesions that can be accurately assessed; bone only blastic lesions with no soft tissue component is not allowed.
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
8. Life expectancy of at least 3 months
9. Progressed during or after CDK4/6 inhibitor combination treatment with non-steroidal aromatase inhibitor (AI)
10. Adequate bone marrow, hepatic, renal and coagulation function

Exclusion Criteria:

1. History of malignancies other than adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥3 years
2. Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor, a protein kinase B (Akt) inhibitor, or a mechanistic target of rapamycin (mTOR) inhibitor
3. Prior treatment with chemotherapy and antibody drug conjugates for advanced disease is not permitted (prior adjuvant or neoadjuvant chemotherapy is permitted)
4. More than 2 lines of prior endocrine therapy treatment
5. Bone only disease that is only blastic with no soft tissue component
6. Subjects with type 1 diabetes or uncontrolled type 2 diabetes
7. Known and untreated, or active, brain or leptomeningeal metastases

   a. Subjects with previously treated central nervous system (CNS) metastases may be enrolled in the study if they meet the following criteria: do not require supportive therapy with steroids; do not have seizures and do not exhibit uncontrolled neurological symptoms; stable disease confirmed by radiographic assessment within at least 4 weeks prior to enrollment
8. Patients with advanced, symptomatic, visceral spread that are at risk of life-threatening complication in the short-term
9. History of clinically significant cardiovascular abnormalities such as: Congestive heart failure (New York Heart Association (NYHA) classification ≥ II within 6 months of study entry

   1. Myocardial infarction within 12 months of study entry
   2. History of any uncontrolled (or untreated) clinically significant cardiac arrhythmias, (e.g., ventricular tachycardia), complete left bundle branch block, high grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block), supraventricular, nodal arrhythmias, or conduction abnormality in the previous 12 months
   3. Uncontrolled hypertension defined by systolic blood pressure (SBP) ≥160 mmHg and/or diastolic blood pressure (DBP) ≥100 mmHg, with or without antihypertensive medication (initiation or adjustment of antihypertensive medication\[s\] is allowed prior to screening)
   4. Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:

      * i. Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, or history of clinically significant/symptomatic bradycardia
      * ii. On screening, inability to determine the corrected QT interval using Fridericia's formula (QTcF) on the ECG (i.e., unreadable or not interpretable) or QTcF \>480 msec (determined by mean of triplicate ECGs at screening)
10. Known hypersensitivity to the study drugs or their components
11. Pregnant or breast-feeding women
12. Concurrent participation in another interventional clinical trial

    1. Subjects must agree not to participate in another clinical trial (other than observational) at any time during participation in VIKTORIA-1.

Primary outcomes:
measure: Progression Free Survival (PFS) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
timeFrame: Approximately 48 months
Secondary outcomes:
measure: Overall Survival (OS) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
timeFrame: From date of randomization to the date of death due to any cause, up to approximately 48 months
measure: Overall Response Rate (ORR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
timeFrame: Up to approximately 48 months
measure: Duration of Response (DOR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
timeFrame: Up to approximately 48 months
measure: Time to Response (TTR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
timeFrame: Up to approximately 48 months
measure: Clinical Benefit Rate (CBR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
timeFrame: Up to approximately 48 months
measure: Quality of Life (QOL)Functional Assessment of Cancer Therapy - Breast Trial Outcome Index (FACT-B TOI) Questions in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
timeFrame: From baseline to 30 Day Safety Follow-up
measure: Quality of Life (QOL) NCCN-FACT Breast Symptom Index -16 (NFBSI-16) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
timeFrame: From baseline to 30 Day Safety Follow-up
measure: Patient-Reported Outcomes in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
timeFrame: From baseline to 30 Day Safety Follow-up
measure: EuroQol 5 in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
timeFrame: From baseline to 30 Day Safety Follow-up
measure: Adverse Events
timeFrame: Up to approximately 48 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Goodyear
country: United States
facility: Arizona Oncology (US Oncology/McKesson) - Goodyear
state: Arizona
city: Jonesboro
country: United States
facility: St. Bernards Medical Center
state: Arkansas
city: Little Rock
country: United States
facility: CARTI Cancer Center
state: Arkansas
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center Inc
state: California
city: Harbor City
country: United States
facility: Kaiser Permanente South Bay Medical Center
state: California
city: Los Alamitos
country: United States
facility: Cancer and Blood Specialty Clinic
state: California
city: Monterey
country: United States
facility: Pacific Cancer Care
state: California
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
city: Oxnard
country: United States
facility: Ventura County Hematology Oncology Specialists
state: California
city: Redlands
country: United States
facility: Redlands Hematology Oncology
state: California
city: Santa Monica
country: United States
facility: UCLA Hematology/Oncology-Santa Monica
state: California
city: Torrance
country: United States
facility: Torrance Memorial Physician Network - Cancer Care
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente Medical Center - Vallejo
state: California
city: Whittier
country: United States
facility: PIH Health Hospital Whittier
state: California
city: New Haven
country: United States
facility: Yale Cancer Center - New Haven
state: Connecticut
city: Hollywood
country: United States
facility: South Broward Hospital District d/b/a Memorial Healthcare System
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida - Jacksonville
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute
state: Florida
city: Winter Haven
country: United States
facility: Bond & Steele Clinic, P.A. d/b/a Bond Clinic, P.A.
state: Florida
city: Thomasville
country: United States
facility: John D. Archbold Memorial Hospital
state: Georgia
city: Arlington Heights
country: United States
facility: Illinois Cancer Specialists - Arlington Heights
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Paducah
country: United States
facility: Mercy Health - Paducah
state: Kentucky
city: Bethesda
country: United States
facility: American Oncology Partners of Maryland, PA
state: Maryland
city: Rockville
country: United States
facility: Maryland Oncology Hematology, P.A. - Rockville
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Lincoln
country: United States
facility: Nebraska Hematology - Oncology, P.C.
state: Nebraska
city: Omaha
country: United States
facility: Oncology Hematology West PC dba Nebraska Cancer Specialists
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Albany
country: United States
facility: New York Oncology Hematology, P.C. - Albany
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Jamaica
country: United States
facility: Queens Hospital Cancer Center
state: New York
city: New York
country: United States
facility: Coleman, Pasmantier & Decter, MDs
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine/New York-Presbyterian Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Syracuse
country: United States
facility: Hematology/Oncology Associates of Central New York
state: New York
city: White Plains
country: United States
facility: White Plains Hospital
state: New York
city: Greensboro
country: United States
facility: Cone Health Cancer Center at Alamance Regional, Hematology/Oncology
state: North Carolina
city: Lumberton
country: United States
facility: Southeast Regional Cancer Center
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: The James Cancer Hospital and Solove Research Institute
state: Ohio
city: Oklahoma City
country: United States
facility: OU Health Stephenson Cancer Center
state: Oklahoma
city: Salem
country: United States
facility: Oregon Oncology Specialists
state: Oregon
city: Tigard
country: United States
facility: Northwest Cancer Specialists, PC - Tigard
state: Oregon
city: Broomall
country: United States
facility: Consultants In Medical Oncology and Hematology, P.C.
state: Pennsylvania
city: Horsham
country: United States
facility: Alliance Cancer Specialists PC
state: Pennsylvania
city: York
country: United States
facility: Cancer Care Associates of York
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Sanford Gynecologic Oncology Clinic
state: South Dakota
city: Austin
country: United States
facility: Texas Oncology - Austin
state: Texas
city: Dallas
country: United States
facility: Texas Oncology P.A. - Dallas
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center
state: Texas
city: El Paso
country: United States
facility: William Beaumont Army Medical Center
state: Texas
city: Houston
country: United States
facility: Oncology Consultants
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
city: McKinney
country: United States
facility: Texas Oncology - McKinney
state: Texas
city: Sugar Land
country: United States
facility: Texas Oncology - Gulf Coast
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Tyler
state: Texas
city: Fort Belvoir
country: United States
facility: Fort Belvoir Community Hospital
state: Virginia
city: Midlothian
country: United States
facility: Bon Secours St. Francis Medical Oncology Center
state: Virginia
city: Newport News
country: United States
facility: Virginia Oncology Associates - Newport News
state: Virginia
city: Richmond
country: United States
facility: VCU Massey Cancer Center
state: Virginia
city: Roanoke
country: United States
facility: Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care - Roanoke
state: Virginia
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties, PLLC - Tacoma
state: Washington
city: Buenos Aires
country: Argentina
facility: Alexander Fleming Institute
city: Buenos Aires
country: Argentina
facility: Buenos Aires British Hospital
city: Buenos Aires
country: Argentina
facility: CENIT Foundation
city: Buenos Aires
country: Argentina
facility: Center for Medical Education and Clinical Research (CEMIC)
city: Buenos Aires
country: Argentina
facility: Fleischer Medical Center
city: Buenos Aires
country: Argentina
facility: Medical Center Austral
city: Buenos Aires
country: Argentina
facility: Pergamino Clinic
city: Córdoba
country: Argentina
facility: Cordoba Oncology Institute (IONC)
city: Paraná
country: Argentina
facility: Center of Nuclear and Molecular Medicine of Entre Rios (CEMENER)
city: Salta
country: Argentina
facility: CEDIT Diagnostic and treatment center
city: San Juan
country: Argentina
facility: CER San Juan
city: Santa Fe
country: Argentina
facility: Rosario's Oncology Institute and Medical Specialities (IOR)
city: Tucumán
country: Argentina
facility: 9 of July Sanatorium
city: Adelaide
country: Australia
facility: Adelaide Oncology & Haematology
city: Fitzroy
country: Australia
facility: St Vincent's Hospital (Melbourne) Ltd
city: Frankston
country: Australia
facility: Peninsula & South Eastern Hematology and Oncology Group (PSEHOG)
city: Nedlands
country: Australia
facility: Hollywood Private Hospital, Breast Cancer Research Centre
city: South Brisbane
country: Australia
facility: Mater Hospital Brisbane, Mater Cancer Care Centre
city: Southport
country: Australia
facility: Icon Cancer Centre- Southport
city: Wahroonga
country: Australia
facility: Sydney Adventist Hospital
city: Woodville
country: Australia
facility: The Queen Elizabeth Hospital
city: Graz
country: Austria
facility: University Hospital Graz, Department of Gynecology and Obstetrics
city: Innsbruck
country: Austria
facility: University Hospital Innsbruck - Tyrolean Hospital, Department of Gynaecology and Obstetrics
city: Linz
country: Austria
facility: Order Hospital Linz Ltd. - Hospital of Sisters of Mercy, Department of Internal Medicine I
city: Salzburg
country: Austria
facility: Salzburg Regional Hospital, Department of Internal Medicine III
city: St. Poelten
country: Austria
facility: University Hospital St. Poelten, Department of Internal Medicine I
city: Vienna
country: Austria
facility: Hospital Hietzing, Department of Gynecology
city: Vienna
country: Austria
facility: Medical University Vienna, Department of Gynecology and Obstetrics
city: Brussels
country: Belgium
facility: Saint Luc University Hospital
city: Charleroi
country: Belgium
facility: Charleroi Grand Hospital (GHDC)
city: Edegem
country: Belgium
facility: University Hospital Antwerp (UZA)
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Leuven
country: Belgium
facility: University Hospitals Leuven, Campus Gasthuisberg
city: Liège
country: Belgium
facility: Citadelle Regional Hospital Center
city: Sint-Niklaas
country: Belgium
facility: VITAZ
city: Verviers
country: Belgium
facility: Centre Hospitalier Peltzer-la-Tourelle
city: Yvoir
country: Belgium
facility: UCL Mont-Godinne University Hospitals
city: Belém
country: Brazil
facility: Oncology Treatment Center
state: Pará
city: Fortaleza
country: Brazil
facility: Pronutrir
city: Ijuí
country: Brazil
facility: ONCOSITE - Clinical Research Center in Oncology
city: Minas Gerais
country: Brazil
facility: Juiz de Fora Eurolatino Research Center
city: Salvador de Bahia
country: Brazil
facility: Bahia Oncology Center
city: São Paulo
country: Brazil
facility: D'OR Institute
city: São Paulo
country: Brazil
facility: Hospital A.C.Camargo
city: Panagyurishte
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment - Uni Hospital, Panagyurishte
city: Sofia
country: Bulgaria
facility: MHAT for Women's Health "Nadezhda"
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment "Serdika", Sofia
city: Sofia
country: Bulgaria
facility: Specialized Hospital for Active Treatment in Oncology, Clinic of Medicial Oncology (Chemotherapy)
city: Varna
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment "Sveta Marina"
city: Vancouver
country: Canada
facility: BC Cancer - Vancouver, Medical Oncology
state: British Columbia
city: Chicoutimi
country: Canada
facility: CIUSSS du Saguenay Lac St-Jean
state: Quebec
city: Montréal
country: Canada
facility: Hospital Notre-Dame
state: Quebec
city: Montréal
country: Canada
facility: Maisonneuve-Rosemont Hospital
state: Quebec
city: Olomouc
country: Czechia
facility: University Hospital Olomouc, Clinic of Oncology
city: Prague
country: Czechia
facility: Thomayer University Hospital, Clinic of Oncology
city: Prague
country: Czechia
facility: University Hospital Bulovka, Institute of Radiation Oncology
city: Prague
country: Czechia
facility: University Hospital Motol, Clinic of Oncology
city: Bordeaux
country: France
facility: Bergonie Institute
city: Caen
country: France
facility: Francois Baclesse Center
city: La Roche-sur-Yon
country: France
facility: La Roche-sur-Yon Hospital
city: Marseille
country: France
facility: CHU La Timone - La Timone Children's Hospital
city: Poitiers
country: France
facility: University Hospital Center of Poitiers
city: Strasbourg
country: France
facility: Saint Anne Clinic
city: Villejuif
country: France
facility: Gustave Roussy
city: Bayreuth
country: Germany
facility: Hospital Bayreuth
city: Berlin
country: Germany
facility: Vivantes Hospital Am Urban
city: Luebeck
country: Germany
facility: Private Practice with Focus on Oncology
city: Mainz
country: Germany
facility: University Hospital Johannes Gutenberg - University of Mainz
city: Mecklenburg
country: Germany
facility: Hospital Suedstadt Rostock
city: Münster
country: Germany
facility: University Hospital Muenster
city: Saarbrücken
country: Germany
facility: Caritas Klinikum
city: Wuppertal
country: Germany
facility: Helios Clinic Wuppertal
city: Athens
country: Greece
facility: Alexandra General Hospital
city: Ioánnina
country: Greece
facility: University General Hospital of Ioannina
city: Larissa
country: Greece
facility: IASO Thessaly SA
city: Thessaloníki
country: Greece
facility: EUROMEDICA General Clinic of Thessaloniki
city: Thessaloníki
country: Greece
facility: Theageneio Anticancer Hospital of Thessaloniki
city: Debrecen
country: Hungary
facility: University of Debrecen Clinical Center, Institute of Oncology
city: Kecskemét
country: Hungary
facility: Bacs-Kiskun County Hospital, Center for Oncoradiology
city: Nyíregyháza
country: Hungary
facility: Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital, Department of Oncology
city: Bangalore
country: India
facility: HCG Cancer Centre
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education and Research (PGIMER)
city: Kolkata
country: India
facility: Tata Medical Center
city: Navi Mumbai
country: India
facility: Tata Memorial Hospital
city: Vellore
country: India
facility: Christian Medical College, Department of Medical Oncology
city: Milan
country: Italy
facility: European Institute of Oncology (IEO), IRCCS
city: Modena
country: Italy
facility: University Polyclinic Hospital of Modena
city: Monza
country: Italy
facility: Local Healthcare Company of Monza (ASST Monza)
city: Parma
country: Italy
facility: University Hospital of Parma
city: Prato
country: Italy
facility: New Hospital of Prato (NOP)
city: Rome
country: Italy
facility: University Hospital Campus Bio-Medico
city: Rome
country: Italy
facility: University Polyclinic Foundation "Agostino Gemelli" - IRCCS
city: Udine
country: Italy
facility: Santa Maria della Misericordia University Hospital of Udine
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Soeul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Soeul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Soeul
country: Korea, Republic of
facility: Samsung Medical Center
city: Soeul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Mexico City
country: Mexico
facility: Clinical Research Center Chapultepec Mexico City
city: Mexico City
country: Mexico
facility: CRYPTEX
city: Mexico City
country: Mexico
facility: ProcliniQ Clinical Research
city: Monterrey
country: Mexico
facility: Filios High Medicine
city: Morelia
country: Mexico
facility: Administrative Society of Health Services, SC
city: Nuevo León
country: Mexico
facility: Avix Clinical Research
city: Nuevo León
country: Mexico
facility: Zambrano Hellion Medical Center
city: Querétaro
country: Mexico
facility: Inbiomedyc
city: Saltillo
country: Mexico
facility: ONCOR Life Medical Center
city: Bydgoszcz
country: Poland
facility: Prof. Franciszek Lukaszczyk Oncology Center in Bydgoszcz, Chemotherapy Outpatient Clinic
city: Konin
country: Poland
facility: Medical Clinic "Komed"
city: Kraków
country: Poland
facility: Maria Sklodowska-Curie Institute of Oncology, Branch in Krakow
city: Opole
country: Poland
facility: Independent Public Healthcare Facility Prof. Tadeusz Koszarowski Opole Oncology Center in Opole, Clinical Oncology Department and Day Hospitalization Unit
city: Siedlce
country: Poland
facility: St. John Paul 2nd Mazovian Provincial Hospital in Siedlce Limited Liability Company, Siedlce Oncology Centre
city: Szczecin
country: Poland
facility: West Pomeranian Oncology Center
city: Warsaw
country: Poland
facility: LUX MED Oncology LLC, Szamocka Hospital, Department of Clinical Oncology/Chemotherapy
city: Warsaw
country: Poland
facility: Maria Sklodowska-Curie - National Research Institute of Oncology
city: Wroclaw
country: Poland
facility: Provincial Specialist Hospital in Wroclaw, Department of Chemotherapy
city: Łódź
country: Poland
facility: Polish Mother's Memorial Hospital-Research Institute
city: Baia Mare
country: Romania
facility: S.C. Oncopremium-Team SRL
city: Bucharest
country: Romania
facility: Prof. Dr. Alexandru Trestioreanu Institute of Oncology
city: Cluj-Napoca
country: Romania
facility: Prof. Dr. Ion Chiricuta Institute of Oncology
city: Craiova
country: Romania
facility: Onco Clinic Consult S.A.
city: Craiova
country: Romania
facility: Oncology Center "Sf. Nectarie"
city: Târgu-Mureş
country: Romania
facility: S.C. Topmed Medical Center SRL
city: Singapore
country: Singapore
facility: Curie Oncology
city: Singapore
country: Singapore
facility: ICON SOC Farrer Park Medical Clinic
city: Singapore
country: Singapore
facility: OncoCare Cancer Centre
city: Singapore
country: Singapore
facility: Raffles Hospital
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Badajoz
country: Spain
facility: Infanta Cristina Hospital
city: Barcelona
country: Spain
facility: Catalan Institute of Oncology, Hospital Duran i Reynals
city: Cáceres
country: Spain
facility: Caceres Hospital Complex - San Pedro de Alcantara General Hospital
city: Madrid
country: Spain
facility: Hospital Ruber Internacional
city: Madrid
country: Spain
facility: University Hospital Foundation Jimenez Diaz
city: Murcia
country: Spain
facility: University Clinical Hospital Virgen de la Arrixaca, Department of Oncology
city: Santiago De Compostela
country: Spain
facility: University Hospital Complex of Santiago (CHUS), Department of Oncology
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: New Taipei City
country: Taiwan
facility: Taipei Medical University - Shuang Ho Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Bath
country: United Kingdom
facility: Royal United Hospital, Department of Oncology/Hematology
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Centre
city: London
country: United Kingdom
facility: Guy's Hospital
city: London
country: United Kingdom
facility: Royal Marsden Hospital - London, Department of Medical Oncology
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
Study officials:
affiliation: Celcuity Inc
name: Nadene Zack
role: STUDY_DIRECTOR
References: