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A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors
Sponsor: Hoffmann-La Roche
Summary
This study will evaluate the efficacy and safety of multiple biomarker-selected treatments in patients with persistent or recurrent rare epithelial ovarian, fallopian tube, or primary peritoneal tumors. Enrollment will take place in two phases: a preliminary phase followed by a potential expansion phase.
Official title: A Phase II, Open-Label, Multicenter, Platform Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
176
Start Date
2021-10-07
Completion Date
2028-05-30
Last Updated
2026-03-10
Healthy Volunteers
No
Conditions
Interventions
Ipatasertib
Ipatasertib will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length = 28 days)
Cobimetinib
Cobimetinib will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length=28 days)
Trastuzumab Emtansine
Trastuzumab Emtansine will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)
Atezolizumab
Atezolizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)
Bevacizumab
Bevacizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)
Paclitaxel
Paclitaxel will be administered intravenously on Days 1, 8, and 15 of each cycle. (Cycle length=28 days)
Giredestrant
Giredestrant will be administered by mouth once a day on Days 1-28 of each cycle (Cycle length=28 days)
Abemaciclib
Abemaciclib will be administered by mouth twice a day during each 28-day cycle
Inavolisib
Inavolisib will be administered by mouth once a day on Days 1-28 of each 28-day cycle
Palbociclib
Palbociclib will be administered by mouth once a day on Days 1-21 of each 28-day cycle
Letrozole
Letrozole will be administered by mouth once a day on Days 1-28 of each 28-day cycle
Olaparib
Olaparib will be administered by mouth twice a day on Days 1-28 of each 28-day cycle
Luteinizing Hormone-Releasing Hormone (LHRH) Agonists
LHRH agonists are required beginning at least 2 weeks prior to initiation of study treatment for premenopausal or perimenopausal women. Acceptable agents include goserelin or leuprolide; triptorelin is also acceptable. Monthly injections of LHRH agonist are preferred.
Cyclophosphamide
Cyclophosphamide will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length = 21 days)
Inavolisib
Inavolisib will be administered by mouth once a day on Days 1-21 of each 21-day cycle
Locations (41)
UCSF Helen Diller Family CCC
San Francisco, California, United States
Washington University School of Medicine
St Louis, Missouri, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Texas Oncology - Gulf Coast
The Woodlands, Texas, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
University of Washington - Seattle Cancer Care Alliance
Seattle, Washington, United States
Cabrini Hospital
Malvern, Victoria, Australia
Princess Margaret Cancer Center
Toronto, Ontario, Canada
McGill University Health Centre - Glen Site
Montreal, Quebec, Canada
Gynekologicko-porodnicka klinika
Prague, Czechia
CHU Besançon - Hôpital Jean Minjoz
Besançon, France
Centre Francois Baclesse
Caen, France
Centre Leon Berard
Lyon, France
Groupe Hospitalier Diaconesses
Paris, France
Centre Eugène Marquis
Rennes, France
ICO - Site René Gauducheau
Saint-Herblain, France
Institut Claudius Regaud
Toulouse, France
Gustave Roussy
Villejuif, France
Kliniken Essen-Mitte Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gynäkologische Onkologie
Essen, Germany
Universitätsklinikum Mannheim
Mannheim, Germany
A.O. U. Consorziale Policlinico di Bari
Bari, Apulia, Italy
Istituto Tumori Napoli
Naples, Campania, Italy
Policlinico Universitario Agostino Gemelli
Rome, Lazio, Italy
IRCCS S. Raffaele
Milan, Lombardy, Italy
LLC Medscan
Moskva, Moscow Oblast, Russia
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Institutio Catalan De Oncologia
Barcelona, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, Spain
Hôpitaux Universitaires de Genève
Geneva, Switzerland
Adana Baskent University Medical Faculty; Oncology
Adana, Turkey (Türkiye)
Baskent Universitesi Ankara Hastanesi; Tıbbi Onkoloji Bölümü
Ankara, Turkey (Türkiye)
Koc University Medical Faculty; Department of Gynecology & Obstetrics
Istanbul, Turkey (Türkiye)
Western General Hospital
Edinburgh, United Kingdom
University College London Hospitals NHS Foundation Trust - University College Hospital
London, United Kingdom