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