To hear about similar clinical trials, please enter your email below

Trial Title: 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)

NCT ID: NCT05501886

Condition: Breast Cancer

Conditions: Official terms:
Breast Neoplasms
Fulvestrant
Palbociclib
Gedatolisib

Conditions: Keywords:
Breast Cancer, Advanced or Metastatic
gedatolisib
HR Positive
ER Positive
HER2 Negative
PIK3CA MT
PI3K

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Gedatolisib
Description: Gedatolisib 180 mg IV given weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off
Arm group label: Arm A - Patients Lacking PIK3CA Mutations (WT)
Arm group label: Arm B - Patients Lacking PIK3CA Mutations (WT)
Arm group label: Arm D - Patients with PIK3CA Mutation (MT)
Arm group label: Arm F - Patients with PIK3CA Mutation (MT)

Other name: PF-05212384

Other name: PKI-587

Intervention type: Drug
Intervention name: Palbociclib
Description: Palbociclib 125 mg PO given daily for 3 weeks (21 days), followed by 1 week off
Arm group label: Arm A - Patients Lacking PIK3CA Mutations (WT)
Arm group label: Arm D - Patients with PIK3CA Mutation (MT)

Other name: IBRANCE

Other name: PD-0332991

Intervention type: Drug
Intervention name: Fulvestrant
Description: 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
Arm group label: Arm A - Patients Lacking PIK3CA Mutations (WT)
Arm group label: Arm B - Patients Lacking PIK3CA Mutations (WT)
Arm group label: Arm C - Patients Lacking PIK3CA Mutations (WT)
Arm group label: Arm D - Patients with PIK3CA Mutation (MT)
Arm group label: Arm E - Patients with PIK3CA Mutation (MT)
Arm group label: Arm F - Patients with PIK3CA Mutation (MT)

Other name: Faslodex

Intervention type: Drug
Intervention name: Alpelisib
Description: Alpelisib 300 mg PO (2 × 150 mg tablets) given daily for 4 weeks (28 days)
Arm group label: Arm E - Patients with PIK3CA Mutation (MT)

Other name: Piqray

Other name: Vijoice

Other name: BYL719

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Alabama at Birmingham

Address:
City: Birmingham
Zip: 35294
Country: United States

Status: Recruiting

Facility:
Name: Arizona Oncology (US Oncology/McKesson) - Goodyear

Address:
City: Goodyear
Zip: 85395
Country: United States

Status: Recruiting

Facility:
Name: St. Bernards Medical Center

Address:
City: Jonesboro
Zip: 72401
Country: United States

Status: Recruiting

Facility:
Name: CARTI Cancer Center

Address:
City: Little Rock
Zip: 72205
Country: United States

Status: Recruiting

Facility:
Name: Pacific Cancer Medical Center Inc

Address:
City: Anaheim
Zip: 92801
Country: United States

Status: Recruiting

Facility:
Name: Kaiser Permanente South Bay Medical Center

Address:
City: Harbor City
Zip: 90710
Country: United States

Status: Recruiting

Facility:
Name: Cancer and Blood Specialty Clinic

Address:
City: Los Alamitos
Zip: 90720
Country: United States

Status: Recruiting

Facility:
Name: Pacific Cancer Care

Address:
City: Monterey
Zip: 93940
Country: United States

Status: Recruiting

Facility:
Name: University of California, Irvine Medical Center

Address:
City: Orange
Zip: 92868
Country: United States

Status: Recruiting

Facility:
Name: Ventura County Hematology Oncology Specialists

Address:
City: Oxnard
Zip: 93030
Country: United States

Status: Not yet recruiting

Facility:
Name: Redlands Hematology Oncology

Address:
City: Redlands
Zip: 92373
Country: United States

Status: Recruiting

Facility:
Name: UCSF Helen Diller Family Comprehensive Cancer Center

Address:
City: San Francisco
Zip: 94158
Country: United States

Status: Not yet recruiting

Facility:
Name: UCLA Hematology/Oncology-Santa Monica

Address:
City: Santa Monica
Zip: 90904
Country: United States

Status: Recruiting

Facility:
Name: Torrance Memorial Physician Network - Cancer Care

Address:
City: Torrance
Zip: 90505
Country: United States

Status: Recruiting

Facility:
Name: Kaiser Permanente Medical Center - Vallejo

Address:
City: Vallejo
Zip: 94589
Country: United States

Status: Recruiting

Facility:
Name: PIH Health Hospital Whittier

Address:
City: Whittier
Zip: 90602-1006
Country: United States

Status: Recruiting

Facility:
Name: Yale Cancer Center - New Haven

Address:
City: New Haven
Zip: 06520-8028
Country: United States

Status: Recruiting

Facility:
Name: South Broward Hospital District d/b/a Memorial Healthcare System

Address:
City: Hollywood
Zip: 33021
Country: United States

Status: Recruiting

Facility:
Name: Cancer Specialists of North Florida - Jacksonville

Address:
City: Jacksonville
Zip: 32256
Country: United States

Status: Recruiting

Facility:
Name: H. Lee Moffitt Cancer Center & Research Institute

Address:
City: Tampa
Zip: 33612
Country: United States

Status: Recruiting

Facility:
Name: Bond & Steele Clinic, P.A. d/b/a Bond Clinic, P.A.

Address:
City: Winter Haven
Zip: 33881
Country: United States

Status: Recruiting

Facility:
Name: John D. Archbold Memorial Hospital

Address:
City: Thomasville
Zip: 31792
Country: United States

Status: Recruiting

Facility:
Name: Illinois Cancer Specialists - Arlington Heights

Address:
City: Arlington Heights
Zip: 60005
Country: United States

Status: Recruiting

Facility:
Name: Fort Wayne Medical Oncology and Hematology

Address:
City: Fort Wayne
Zip: 46845
Country: United States

Status: Recruiting

Facility:
Name: University of Kentucky Medical Center

Address:
City: Lexington
Zip: 40536-0293
Country: United States

Status: Recruiting

Facility:
Name: Mercy Health - Paducah

Address:
City: Paducah
Zip: 42003
Country: United States

Status: Recruiting

Facility:
Name: American Oncology Partners of Maryland, PA

Address:
City: Bethesda
Zip: 20817-7847
Country: United States

Status: Recruiting

Facility:
Name: Maryland Oncology Hematology, P.A. - Rockville

Address:
City: Rockville
Zip: 20850
Country: United States

Status: Recruiting

Facility:
Name: Dana Farber Cancer Institute

Address:
City: Boston
Zip: 02215-5450
Country: United States

Status: Recruiting

Facility:
Name: Beth Israel Deaconess Medical Center

Address:
City: Boston
Zip: 02215
Country: United States

Status: Recruiting

Facility:
Name: Henry Ford Hospital

Address:
City: Detroit
Zip: 48202
Country: United States

Status: Recruiting

Facility:
Name: Nebraska Hematology - Oncology, P.C.

Address:
City: Lincoln
Zip: 68506
Country: United States

Status: Recruiting

Facility:
Name: Oncology Hematology West PC dba Nebraska Cancer Specialists

Address:
City: Omaha
Zip: 68130
Country: United States

Status: Recruiting

Facility:
Name: University of Nebraska Medical Center

Address:
City: Omaha
Zip: 68198
Country: United States

Status: Recruiting

Facility:
Name: New York Oncology Hematology, P.C. - Albany

Address:
City: Albany
Zip: 12206
Country: United States

Status: Recruiting

Facility:
Name: Montefiore Medical Center

Address:
City: Bronx
Zip: 10467
Country: United States

Status: Recruiting

Facility:
Name: Queens Hospital Cancer Center

Address:
City: Jamaica
Zip: 11432
Country: United States

Status: Recruiting

Facility:
Name: Coleman, Pasmantier & Decter, MDs

Address:
City: New York
Zip: 10021-5302
Country: United States

Status: Recruiting

Facility:
Name: Weill Cornell Medicine/New York-Presbyterian Hospital

Address:
City: New York
Zip: 10021
Country: United States

Status: Recruiting

Facility:
Name: University of Rochester Medical Center

Address:
City: Rochester
Zip: 14642
Country: United States

Status: Not yet recruiting

Facility:
Name: Hematology/Oncology Associates of Central New York

Address:
City: Syracuse
Zip: 13057
Country: United States

Status: Recruiting

Facility:
Name: White Plains Hospital

Address:
City: White Plains
Zip: 10601
Country: United States

Status: Recruiting

Facility:
Name: Cone Health Cancer Center at Alamance Regional, Hematology/Oncology

Address:
City: Greensboro
Zip: 27403
Country: United States

Status: Recruiting

Facility:
Name: Southeast Regional Cancer Center

Address:
City: Lumberton
Zip: 28359
Country: United States

Status: Recruiting

Facility:
Name: University Hospitals Cleveland Medical Center

Address:
City: Cleveland
Zip: 44106-1716
Country: United States

Status: Recruiting

Facility:
Name: The James Cancer Hospital and Solove Research Institute

Address:
City: Columbus
Zip: 43210
Country: United States

Status: Recruiting

Facility:
Name: OU Health Stephenson Cancer Center

Address:
City: Oklahoma City
Zip: 73104
Country: United States

Status: Recruiting

Facility:
Name: Oregon Oncology Specialists

Address:
City: Salem
Zip: 97301
Country: United States

Status: Recruiting

Facility:
Name: Northwest Cancer Specialists, PC - Tigard

Address:
City: Tigard
Zip: 97223
Country: United States

Status: Recruiting

Facility:
Name: Consultants In Medical Oncology and Hematology, P.C.

Address:
City: Broomall
Zip: 19008
Country: United States

Status: Recruiting

Facility:
Name: Alliance Cancer Specialists PC

Address:
City: Horsham
Zip: 19044
Country: United States

Status: Recruiting

Facility:
Name: Cancer Care Associates of York

Address:
City: York
Zip: 17403
Country: United States

Status: Recruiting

Facility:
Name: Sanford Gynecologic Oncology Clinic

Address:
City: Sioux Falls
Zip: 57104
Country: United States

Status: Recruiting

Facility:
Name: Texas Oncology - Austin

Address:
City: Austin
Zip: 78745
Country: United States

Status: Recruiting

Facility:
Name: Texas Oncology P.A. - Dallas

Address:
City: Dallas
Zip: 75230
Country: United States

Status: Recruiting

Facility:
Name: Texas Oncology - Baylor Charles A. Sammons Cancer Center

Address:
City: Dallas
Zip: 75246
Country: United States

Status: Recruiting

Facility:
Name: William Beaumont Army Medical Center

Address:
City: El Paso
Zip: 79920
Country: United States

Status: Recruiting

Facility:
Name: Oncology Consultants

Address:
City: Houston
Zip: 77030
Country: United States

Status: Recruiting

Facility:
Name: University of Texas MD Anderson Cancer Center

Address:
City: Houston
Zip: 77030
Country: United States

Status: Recruiting

Facility:
Name: Brooke Army Medical Center

Address:
City: Houston
Zip: 78234
Country: United States

Status: Recruiting

Facility:
Name: Texas Oncology - McKinney

Address:
City: McKinney
Zip: 75071
Country: United States

Status: Recruiting

Facility:
Name: Texas Oncology - Gulf Coast

Address:
City: Sugar Land
Zip: 77479
Country: United States

Status: Recruiting

Facility:
Name: Texas Oncology - Tyler

Address:
City: Tyler
Zip: 75702
Country: United States

Status: Recruiting

Facility:
Name: Fort Belvoir Community Hospital

Address:
City: Fort Belvoir
Zip: 22060
Country: United States

Status: Recruiting

Facility:
Name: Bon Secours St. Francis Medical Oncology Center

Address:
City: Midlothian
Zip: 23114
Country: United States

Status: Recruiting

Facility:
Name: Virginia Oncology Associates - Newport News

Address:
City: Newport News
Zip: 23502
Country: United States

Status: Recruiting

Facility:
Name: VCU Massey Cancer Center

Address:
City: Richmond
Zip: 23219
Country: United States

Status: Recruiting

Facility:
Name: Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care - Roanoke

Address:
City: Roanoke
Zip: 24014
Country: United States

Status: Recruiting

Facility:
Name: Fred Hutchinson Cancer Center

Address:
City: Seattle
Zip: 98109-1023
Country: United States

Status: Recruiting

Facility:
Name: Northwest Medical Specialties, PLLC - Tacoma

Address:
City: Tacoma
Zip: 98405
Country: United States

Status: Recruiting

Facility:
Name: Alexander Fleming Institute

Address:
City: Buenos Aires
Country: Argentina

Status: Recruiting

Facility:
Name: Buenos Aires British Hospital

Address:
City: Buenos Aires
Country: Argentina

Status: Recruiting

Facility:
Name: CENIT Foundation

Address:
City: Buenos Aires
Country: Argentina

Status: Recruiting

Facility:
Name: Center for Medical Education and Clinical Research (CEMIC)

Address:
City: Buenos Aires
Country: Argentina

Status: Recruiting

Facility:
Name: Fleischer Medical Center

Address:
City: Buenos Aires
Country: Argentina

Status: Recruiting

Facility:
Name: Medical Center Austral

Address:
City: Buenos Aires
Country: Argentina

Status: Recruiting

Facility:
Name: Pergamino Clinic

Address:
City: Buenos Aires
Country: Argentina

Status: Not yet recruiting

Facility:
Name: Cordoba Oncology Institute (IONC)

Address:
City: Córdoba
Country: Argentina

Status: Recruiting

Facility:
Name: Center of Nuclear and Molecular Medicine of Entre Rios (CEMENER)

Address:
City: Paraná
Country: Argentina

Status: Recruiting

Facility:
Name: CEDIT Diagnostic and treatment center

Address:
City: Salta
Country: Argentina

Status: Recruiting

Facility:
Name: CER San Juan

Address:
City: San Juan
Country: Argentina

Status: Recruiting

Facility:
Name: Rosario's Oncology Institute and Medical Specialities (IOR)

Address:
City: Santa Fe
Country: Argentina

Status: Recruiting

Facility:
Name: 9 of July Sanatorium

Address:
City: Tucumán
Country: Argentina

Status: Recruiting

Facility:
Name: Adelaide Oncology & Haematology

Address:
City: Adelaide
Country: Australia

Status: Recruiting

Facility:
Name: St Vincent's Hospital (Melbourne) Ltd

Address:
City: Fitzroy
Country: Australia

Status: Recruiting

Facility:
Name: Peninsula & South Eastern Hematology and Oncology Group (PSEHOG)

Address:
City: Frankston
Country: Australia

Status: Recruiting

Facility:
Name: Hollywood Private Hospital, Breast Cancer Research Centre

Address:
City: Nedlands
Country: Australia

Status: Recruiting

Facility:
Name: Mater Hospital Brisbane, Mater Cancer Care Centre

Address:
City: South Brisbane
Country: Australia

Status: Recruiting

Facility:
Name: Icon Cancer Centre- Southport

Address:
City: Southport
Country: Australia

Status: Recruiting

Facility:
Name: Sydney Adventist Hospital

Address:
City: Wahroonga
Country: Australia

Status: Recruiting

Facility:
Name: The Queen Elizabeth Hospital

Address:
City: Woodville
Country: Australia

Status: Recruiting

Facility:
Name: University Hospital Graz, Department of Gynecology and Obstetrics

Address:
City: Graz
Country: Austria

Status: Recruiting

Facility:
Name: University Hospital Innsbruck - Tyrolean Hospital, Department of Gynaecology and Obstetrics

Address:
City: Innsbruck
Country: Austria

Status: Recruiting

Facility:
Name: Order Hospital Linz Ltd. - Hospital of Sisters of Mercy, Department of Internal Medicine I

Address:
City: Linz
Country: Austria

Status: Recruiting

Facility:
Name: Salzburg Regional Hospital, Department of Internal Medicine III

Address:
City: Salzburg
Country: Austria

Status: Recruiting

Facility:
Name: University Hospital St. Poelten, Department of Internal Medicine I

Address:
City: St. Poelten
Country: Austria

Status: Recruiting

Facility:
Name: Hospital Hietzing, Department of Gynecology

Address:
City: Vienna
Country: Austria

Status: Recruiting

Facility:
Name: Medical University Vienna, Department of Gynecology and Obstetrics

Address:
City: Vienna
Country: Austria

Status: Recruiting

Facility:
Name: Saint Luc University Hospital

Address:
City: Brussels
Country: Belgium

Status: Recruiting

Facility:
Name: Charleroi Grand Hospital (GHDC)

Address:
City: Charleroi
Country: Belgium

Status: Recruiting

Facility:
Name: University Hospital Antwerp (UZA)

Address:
City: Edegem
Country: Belgium

Status: Recruiting

Facility:
Name: AZ Groeninge

Address:
City: Kortrijk
Country: Belgium

Status: Recruiting

Facility:
Name: University Hospitals Leuven, Campus Gasthuisberg

Address:
City: Leuven
Country: Belgium

Status: Recruiting

Facility:
Name: Citadelle Regional Hospital Center

Address:
City: Liège
Country: Belgium

Status: Recruiting

Facility:
Name: VITAZ

Address:
City: Sint-Niklaas
Country: Belgium

Status: Recruiting

Facility:
Name: Centre Hospitalier Peltzer-la-Tourelle

Address:
City: Verviers
Country: Belgium

Status: Recruiting

Facility:
Name: UCL Mont-Godinne University Hospitals

Address:
City: Yvoir
Country: Belgium

Status: Recruiting

Facility:
Name: Oncology Treatment Center

Address:
City: Belém
Country: Brazil

Status: Recruiting

Facility:
Name: Pronutrir

Address:
City: Fortaleza
Country: Brazil

Status: Recruiting

Facility:
Name: ONCOSITE - Clinical Research Center in Oncology

Address:
City: Ijuí
Country: Brazil

Status: Recruiting

Facility:
Name: Juiz de Fora Eurolatino Research Center

Address:
City: Minas Gerais
Country: Brazil

Status: Recruiting

Facility:
Name: Bahia Oncology Center

Address:
City: Salvador de Bahia
Country: Brazil

Status: Recruiting

Facility:
Name: D'OR Institute

Address:
City: São Paulo
Country: Brazil

Status: Recruiting

Facility:
Name: Hospital A.C.Camargo

Address:
City: São Paulo
Country: Brazil

Status: Recruiting

Facility:
Name: Multiprofile Hospital for Active Treatment - Uni Hospital, Panagyurishte

Address:
City: Panagyurishte
Country: Bulgaria

Status: Recruiting

Facility:
Name: MHAT for Women's Health "Nadezhda"

Address:
City: Sofia
Country: Bulgaria

Status: Recruiting

Facility:
Name: Multiprofile Hospital for Active Treatment "Serdika", Sofia

Address:
City: Sofia
Country: Bulgaria

Status: Recruiting

Facility:
Name: Specialized Hospital for Active Treatment in Oncology, Clinic of Medicial Oncology (Chemotherapy)

Address:
City: Sofia
Country: Bulgaria

Status: Recruiting

Facility:
Name: University Multiprofile Hospital for Active Treatment "Sveta Marina"

Address:
City: Varna
Country: Bulgaria

Status: Recruiting

Facility:
Name: BC Cancer - Vancouver, Medical Oncology

Address:
City: Vancouver
Country: Canada

Status: Not yet recruiting

Facility:
Name: CIUSSS du Saguenay Lac St-Jean

Address:
City: Chicoutimi
Country: Canada

Status: Recruiting

Facility:
Name: Hospital Notre-Dame

Address:
City: Montréal
Country: Canada

Status: Not yet recruiting

Facility:
Name: Maisonneuve-Rosemont Hospital

Address:
City: Montréal
Country: Canada

Status: Recruiting

Facility:
Name: University Hospital Olomouc, Clinic of Oncology

Address:
City: Olomouc
Country: Czechia

Status: Recruiting

Facility:
Name: Thomayer University Hospital, Clinic of Oncology

Address:
City: Prague
Country: Czechia

Status: Recruiting

Facility:
Name: University Hospital Bulovka, Institute of Radiation Oncology

Address:
City: Prague
Country: Czechia

Status: Recruiting

Facility:
Name: University Hospital Motol, Clinic of Oncology

Address:
City: Prague
Country: Czechia

Status: Recruiting

Facility:
Name: Bergonie Institute

Address:
City: Bordeaux
Country: France

Status: Recruiting

Facility:
Name: Francois Baclesse Center

Address:
City: Caen
Zip: 14076
Country: France

Status: Recruiting

Facility:
Name: La Roche-sur-Yon Hospital

Address:
City: La Roche-sur-Yon
Zip: 85925
Country: France

Status: Recruiting

Facility:
Name: CHU La Timone - La Timone Children's Hospital

Address:
City: Marseille
Country: France

Status: Recruiting

Facility:
Name: University Hospital Center of Poitiers

Address:
City: Poitiers
Country: France

Status: Recruiting

Facility:
Name: Saint Anne Clinic

Address:
City: Strasbourg
Country: France

Status: Recruiting

Facility:
Name: Gustave Roussy

Address:
City: Villejuif
Country: France

Status: Recruiting

Facility:
Name: Hospital Bayreuth

Address:
City: Bayreuth
Country: Germany

Status: Recruiting

Facility:
Name: Vivantes Hospital Am Urban

Address:
City: Berlin
Country: Germany

Status: Recruiting

Facility:
Name: Private Practice with Focus on Oncology

Address:
City: Luebeck
Country: Germany

Status: Recruiting

Facility:
Name: University Hospital Johannes Gutenberg - University of Mainz

Address:
City: Mainz
Country: Germany

Status: Recruiting

Facility:
Name: Hospital Suedstadt Rostock

Address:
City: Mecklenburg
Country: Germany

Status: Recruiting

Facility:
Name: University Hospital Muenster

Address:
City: Münster
Country: Germany

Status: Recruiting

Facility:
Name: Caritas Klinikum

Address:
City: Saarbrücken
Country: Germany

Status: Recruiting

Facility:
Name: Helios Clinic Wuppertal

Address:
City: Wuppertal
Country: Germany

Status: Recruiting

Facility:
Name: Alexandra General Hospital

Address:
City: Athens
Country: Greece

Status: Recruiting

Facility:
Name: University General Hospital of Ioannina

Address:
City: Ioánnina
Country: Greece

Status: Recruiting

Facility:
Name: IASO Thessaly SA

Address:
City: Larissa
Country: Greece

Status: Recruiting

Facility:
Name: EUROMEDICA General Clinic of Thessaloniki

Address:
City: Thessaloníki
Country: Greece

Status: Recruiting

Facility:
Name: Theageneio Anticancer Hospital of Thessaloniki

Address:
City: Thessaloníki
Country: Greece

Status: Recruiting

Facility:
Name: University of Debrecen Clinical Center, Institute of Oncology

Address:
City: Debrecen
Country: Hungary

Status: Recruiting

Facility:
Name: Bacs-Kiskun County Hospital, Center for Oncoradiology

Address:
City: Kecskemét
Country: Hungary

Status: Recruiting

Facility:
Name: Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital, Department of Oncology

Address:
City: Nyíregyháza
Country: Hungary

Status: Recruiting

Facility:
Name: HCG Cancer Centre

Address:
City: Bangalore
Country: India

Status: Not yet recruiting

Facility:
Name: Postgraduate Institute of Medical Education and Research (PGIMER)

Address:
City: Chandigarh
Country: India

Status: Not yet recruiting

Facility:
Name: Tata Medical Center

Address:
City: Kolkata
Country: India

Status: Not yet recruiting

Facility:
Name: Tata Memorial Hospital

Address:
City: Navi Mumbai
Country: India

Status: Not yet recruiting

Facility:
Name: Christian Medical College, Department of Medical Oncology

Address:
City: Vellore
Country: India

Status: Not yet recruiting

Facility:
Name: European Institute of Oncology (IEO), IRCCS

Address:
City: Milan
Country: Italy

Status: Recruiting

Facility:
Name: University Polyclinic Hospital of Modena

Address:
City: Modena
Country: Italy

Status: Recruiting

Facility:
Name: Local Healthcare Company of Monza (ASST Monza)

Address:
City: Monza
Country: Italy

Status: Recruiting

Facility:
Name: University Hospital of Parma

Address:
City: Parma
Country: Italy

Status: Recruiting

Facility:
Name: New Hospital of Prato (NOP)

Address:
City: Prato
Country: Italy

Status: Recruiting

Facility:
Name: University Hospital Campus Bio-Medico

Address:
City: Rome
Country: Italy

Status: Recruiting

Facility:
Name: University Polyclinic Foundation "Agostino Gemelli" - IRCCS

Address:
City: Rome
Country: Italy

Status: Recruiting

Facility:
Name: Santa Maria della Misericordia University Hospital of Udine

Address:
City: Udine
Country: Italy

Status: Recruiting

Facility:
Name: Asan Medical Center

Address:
City: Seoul
Country: Korea, Republic of

Status: Recruiting

Facility:
Name: Gangnam Severance Hospital

Address:
City: Soeul
Country: Korea, Republic of

Status: Recruiting

Facility:
Name: Korea University Anam Hospital

Address:
City: Soeul
Country: Korea, Republic of

Status: Recruiting

Facility:
Name: Samsung Medical Center

Address:
City: Soeul
Country: Korea, Republic of

Status: Recruiting

Facility:
Name: Severance Hospital, Yonsei University Health System

Address:
City: Soeul
Country: Korea, Republic of

Status: Recruiting

Facility:
Name: Ulsan University Hospital

Address:
City: Ulsan
Country: Korea, Republic of

Status: Recruiting

Facility:
Name: Clinical Research Center Chapultepec Mexico City

Address:
City: Mexico City
Country: Mexico

Status: Recruiting

Facility:
Name: CRYPTEX

Address:
City: Mexico City
Country: Mexico

Status: Recruiting

Facility:
Name: ProcliniQ Clinical Research

Address:
City: Mexico City
Country: Mexico

Status: Recruiting

Facility:
Name: Filios High Medicine

Address:
City: Monterrey
Zip: 64460
Country: Mexico

Status: Recruiting

Facility:
Name: Administrative Society of Health Services, SC

Address:
City: Morelia
Country: Mexico

Status: Recruiting

Facility:
Name: Avix Clinical Research

Address:
City: Nuevo León
Country: Mexico

Status: Recruiting

Facility:
Name: Zambrano Hellion Medical Center

Address:
City: Nuevo León
Country: Mexico

Status: Recruiting

Facility:
Name: Inbiomedyc

Address:
City: Querétaro
Country: Mexico

Status: Recruiting

Facility:
Name: ONCOR Life Medical Center

Address:
City: Saltillo
Country: Mexico

Status: Recruiting

Facility:
Name: Prof. Franciszek Lukaszczyk Oncology Center in Bydgoszcz, Chemotherapy Outpatient Clinic

Address:
City: Bydgoszcz
Country: Poland

Status: Recruiting

Facility:
Name: Medical Clinic "Komed"

Address:
City: Konin
Country: Poland

Status: Recruiting

Facility:
Name: Maria Sklodowska-Curie Institute of Oncology, Branch in Krakow

Address:
City: Kraków
Country: Poland

Status: Recruiting

Facility:
Name: Independent Public Healthcare Facility Prof. Tadeusz Koszarowski Opole Oncology Center in Opole, Clinical Oncology Department and Day Hospitalization Unit

Address:
City: Opole
Country: Poland

Status: Recruiting

Facility:
Name: St. John Paul 2nd Mazovian Provincial Hospital in Siedlce Limited Liability Company, Siedlce Oncology Centre

Address:
City: Siedlce
Country: Poland

Status: Recruiting

Facility:
Name: West Pomeranian Oncology Center

Address:
City: Szczecin
Country: Poland

Status: Recruiting

Facility:
Name: LUX MED Oncology LLC, Szamocka Hospital, Department of Clinical Oncology/Chemotherapy

Address:
City: Warsaw
Country: Poland

Status: Recruiting

Facility:
Name: Maria Sklodowska-Curie - National Research Institute of Oncology

Address:
City: Warsaw
Country: Poland

Status: Recruiting

Facility:
Name: Provincial Specialist Hospital in Wroclaw, Department of Chemotherapy

Address:
City: Wroclaw
Country: Poland

Status: Recruiting

Facility:
Name: Polish Mother's Memorial Hospital-Research Institute

Address:
City: Łódź
Country: Poland

Status: Recruiting

Facility:
Name: S.C. Oncopremium-Team SRL

Address:
City: Baia Mare
Country: Romania

Status: Recruiting

Facility:
Name: Prof. Dr. Alexandru Trestioreanu Institute of Oncology

Address:
City: Bucharest
Country: Romania

Status: Recruiting

Facility:
Name: Prof. Dr. Ion Chiricuta Institute of Oncology

Address:
City: Cluj-Napoca
Country: Romania

Status: Recruiting

Facility:
Name: Onco Clinic Consult S.A.

Address:
City: Craiova
Country: Romania

Status: Recruiting

Facility:
Name: Oncology Center "Sf. Nectarie"

Address:
City: Craiova
Country: Romania

Status: Recruiting

Facility:
Name: S.C. Topmed Medical Center SRL

Address:
City: Târgu-Mureş
Country: Romania

Status: Recruiting

Facility:
Name: Curie Oncology

Address:
City: Singapore
Country: Singapore

Status: Recruiting

Facility:
Name: ICON SOC Farrer Park Medical Clinic

Address:
City: Singapore
Country: Singapore

Status: Recruiting

Facility:
Name: OncoCare Cancer Centre

Address:
City: Singapore
Country: Singapore

Status: Recruiting

Facility:
Name: Raffles Hospital

Address:
City: Singapore
Country: Singapore

Status: Recruiting

Facility:
Name: Tan Tock Seng Hospital

Address:
City: Singapore
Country: Singapore

Status: Recruiting

Facility:
Name: Infanta Cristina Hospital

Address:
City: Badajoz
Country: Spain

Status: Recruiting

Facility:
Name: Catalan Institute of Oncology, Hospital Duran i Reynals

Address:
City: Barcelona
Country: Spain

Status: Recruiting

Facility:
Name: Caceres Hospital Complex - San Pedro de Alcantara General Hospital

Address:
City: Cáceres
Country: Spain

Status: Recruiting

Facility:
Name: Hospital Ruber Internacional

Address:
City: Madrid
Country: Spain

Status: Recruiting

Facility:
Name: University Hospital Foundation Jimenez Diaz

Address:
City: Madrid
Country: Spain

Status: Recruiting

Facility:
Name: University Clinical Hospital Virgen de la Arrixaca, Department of Oncology

Address:
City: Murcia
Country: Spain

Status: Recruiting

Facility:
Name: University Hospital Complex of Santiago (CHUS), Department of Oncology

Address:
City: Santiago De Compostela
Country: Spain

Status: Recruiting

Facility:
Name: Kaohsiung Medical University Chung-Ho Memorial Hospital

Address:
City: Kaohsiung
Country: Taiwan

Status: Recruiting

Facility:
Name: Taipei Medical University - Shuang Ho Hospital

Address:
City: New Taipei City
Country: Taiwan

Status: Not yet recruiting

Facility:
Name: China Medical University Hospital

Address:
City: Taichung
Country: Taiwan

Status: Not yet recruiting

Facility:
Name: National Cheng Kung University Hospital

Address:
City: Tainan
Country: Taiwan

Status: Recruiting

Facility:
Name: National Taiwan University Hospital

Address:
City: Taipei
Country: Taiwan

Status: Recruiting

Facility:
Name: Taipei Veterans General Hospital

Address:
City: Taipei
Country: Taiwan

Status: Not yet recruiting

Facility:
Name: Royal United Hospital, Department of Oncology/Hematology

Address:
City: Bath
Country: United Kingdom

Status: Not yet recruiting

Facility:
Name: Velindre Cancer Centre

Address:
City: Cardiff
Country: United Kingdom

Status: Not yet recruiting

Facility:
Name: Guy's Hospital

Address:
City: London
Country: United Kingdom

Status: Not yet recruiting

Facility:
Name: Royal Marsden Hospital - London, Department of Medical Oncology

Address:
City: London
Country: United Kingdom

Status: Not yet recruiting

Facility:
Name: The Christie NHS Foundation Trust

Address:
City: Manchester
Country: United Kingdom

Status: Not yet recruiting

Facility:
Name: Nottingham City Hospital

Address:
City: Nottingham
Country: United Kingdom

Status: Not yet recruiting

Start date: September 30, 2022

Completion date: September 30, 2026

Lead sponsor:
Agency: Celcuity Inc
Agency class: Industry

Source: Celcuity Inc

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05501886

Login to your account

Did you forget your password?