Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer
Фаза 4 – наблюдение след одобрението на пазара
Заболявания:
Cervical Cancer
Спонсор: Pfizer
Налично на:
БГ
Обобщение
TIVDAK is used for the treatment of cervical cancer that has come back after chemotherapy. Chemotherapy is a treatment that uses medicines to stop the growth of cancer cells. This is done either by killing the cells or by stopping them from growing. The purpose of this study is to learn about possible side effects of TIVDAK, specially to any side effect that is related to the eye. A side effect is anything a medicine does to your body that is not part of how the medicine treats disease.
* This study is seeking for participants who: Are willing to take all the required eye tests
* Have not received TIVDAK before
* Do not have any active eye issues.
Participants will receive TIVDAK once every 3 weeks as an infusion that will be injected into the vein. Participants will visit an eye care provider at 3 stages:
* before starting the treatment,
* before each of the first 9 infusions
* then monthly for 3 months after they stop taking TIVDAK. Treatment with TIVDAK will continue until it is not working anymore against the participant's cancer.
Кой може да участва
Inclusion criteria:
1. Must have recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
2. Treating physician has determined that treatment with Tivdak is appropriate for the participant according to US Prescribing Information
3. Must sign an informed consent form indicating that the participant understands the purpose and procedures required for the study and are willing to participate
4. Must be willing to undergo repeated ocular assessments as required by the study and regular clinic visits according to local standard practice of the study site
5. Must agree to use effective contraception according to the US Prescribing Information
Exclusion criteria:
1. Active ocular disease at baseline per investigator assessment
2. Previous treatment with Tivdak
3. Previous administration of an investigational drug within 30 days
4. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may, in the investigator'
Интервенции
TIVDAK
DRUG
Места на провеждане
93
Puerto Rico (1)
Puerto Rico Cancer Specialists Clinical Trials
San Juan
САЩ (92)
Grady Health System Correll Pavilion
Atlanta , Georgia
Grady Memorial Hospital Investigational Drug Service
Atlanta , Georgia
Emory University Hospital Midtown
Atlanta , Georgia
Emory University Hospital
Atlanta , Georgia
The Emory Clinic
Atlanta , Georgia
Winship Cancer Institute
Atlanta , Georgia
Georgia Cancer Center at Augusta University
Augusta , Georgia
Texas Oncology - Central South
Austin , Texas
Texas Oncology - Central South
Austin , Texas
Texas Oncology - Central South
Austin , Texas
Mount Sinai Comprehensive Cancer Center - Aventura
Aventura , Florida
Intermountain Health Saint Vincent Regional Hospital
Billings , Montana
Saint Vincent Regional Hospital- Cancer Centers of Montana
Billings , Montana
Yellowstone Eye Care
Billings , Montana
Intermountain Health West End Clinic- Gynecologic Oncology
Billings , Montana
Florida Cancer Specialists
Bonita Springs , Florida
Florida Cancer Specialists
Bradenton , Florida
Maimonides Medical Center
Brooklyn , New York
M Health Fairview Clinics and Specialty Center
Burnsville , Minnesota
MD Anderson Cancer Center at Cooper
Camden , New Jersey
Florida Cancer Specialists
Cape Coral , Florida
Miami Valley Hospital South
Centerville , Ohio
University of Virginia Comprehensive Cancer Center
Charlottesville , Virginia
University of Virginia
Charlottesville , Virginia
UVA Health Cancer Care Pantops
Charlottesville , Virginia
Rush University Medical Center
Chicago , Illinois
Rush University Medical Center, Ophthalmology
Chicago , Illinois
Broward Health Coral Springs
Coral Springs , Florida
Florida Cancer Specialists
Daytona Beach , Florida
Broward Health North
Deerfield Beach , Florida
M Health Fairview Clinics and Surgery Center
Edina , Minnesota
Florida Cancer Specialists
Fleming Island , Florida
Broward Health Imperial Point
Fort Lauderdale , Florida
Broward Health Medical Center
Fort Lauderdale , Florida
Florida Cancer Specialists
Fort Myers , Florida
Florida Cancer Specialists
Fort Myers , Florida
Texas Oncology - Central South
Harlingen , Texas
Indiana University Health University Hospital
Indianapolis , Indiana
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis , Indiana
Sidney & Lois Eskenazi Hospital
Indianapolis , Indiana
St. Dominic - Jackson Memorial Hospital
Jackson , Mississippi
St. Dominic Gynecologic Oncology
Jackson , Mississippi
Kettering Health Cancer Center
Kettering , Ohio
Kettering Health Main Campus
Kettering , Ohio
Women's Cancer Center of Nevada
Las Vegas , Nevada
Norton Cancer Institute - Downtown
Louisville , Kentucky
Norton Hospital
Louisville , Kentucky
Norton Cancer Institute St Matthews Campus
Louisville , Kentucky
Norton Women's and Children's Hospital
Louisville , Kentucky
M Health Fairview Clinics and Surgery Center
Maple Grove , Minnesota
M Health Fairview St. John's Hospital
Maplewood , Minnesota
Texas Oncology - Central South
McAllen , Texas
HCA Mercy Hospital
Miami , Florida
Mount Sinai Comprehensive Cancer Center
Miami Beach , Florida
Mount Sinai Medical Center of Florida, Inc
Miami Beach , Florida
M Health Fairview Clinics and Surgery Center
Minneapolis , Minnesota
Florida Cancer Specialists
N. Venice , Florida
Florida Cancer Specialists
Naples , Florida
University Medical Center - New Orleans
New Orleans , Louisiana
Columbia University Medical Center - Herbert Irving Pavilion
New York , New York
NOT_YET_RECRUITING
IP Address: Columbia University Medical Center/New York Presbyterian Hospital Research Pharmacy
New York , New York
NOT_YET_RECRUITING
Orlando Health Cancer Institute
Orlando , Florida
Orlando Health Orlando Regional Medical Center
Orlando , Florida
Orlando Health Winnie Palmer Hospital for Women & Babies
Orlando , Florida
Illinois Eye Center
Peoria , Illinois
OSF Saint Francis Medical Center (OSF SFMC)
Peoria , Illinois
HonorHealth Cancer Care - Biltmore - AZCCC Imaging
Phoenix , Arizona
HonorHealth Cancer Care - Biltmore - HonorHealth Research Pharmacy
Phoenix , Arizona
Sonora Quest Laboratories, LLC
Phoenix , Arizona
South West Medical Imaging (SMIL)
Phoenix , Arizona
Florida Cancer Specialists
Port Charlotte , Florida
Women & Infants Hospital of Rhode Island/The Program in Women´s Oncology - Clinic
Providence , Rhode Island
Women & Infants Hospital of Rhode Island
Providence , Rhode Island
Carilion Clinic Gynecologic Oncology
Roanoke , Virginia
Florida Cancer Specialists
Sarasota , Florida
Schwartz Laser Eye Center
Scottsdale , Arizona
Virginia G. Piper Cancer Pharmacy - HonorHealth Research Pharmacy
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