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ACTIVE NOT RECRUITING
NCT04931342
PHASE2

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

View on ClinicalTrials.gov

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

DRUG

Ipatasertib

Ipatasertib will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length = 28 days)

DRUG

Cobimetinib

Cobimetinib will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length=28 days)

DRUG

Trastuzumab Emtansine

Trastuzumab Emtansine will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)

DRUG

Atezolizumab

Atezolizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)

DRUG

Bevacizumab

Bevacizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)

DRUG

Paclitaxel

Paclitaxel will be administered intravenously on Days 1, 8, and 15 of each cycle. (Cycle length=28 days)

DRUG

Giredestrant

Giredestrant will be administered by mouth once a day on Days 1-28 of each cycle (Cycle length=28 days)

DRUG

Abemaciclib

Abemaciclib will be administered by mouth twice a day during each 28-day cycle

DRUG

Inavolisib

Inavolisib will be administered by mouth once a day on Days 1-28 of each 28-day cycle

DRUG

Palbociclib

Palbociclib will be administered by mouth once a day on Days 1-21 of each 28-day cycle

DRUG

Letrozole

Letrozole will be administered by mouth once a day on Days 1-28 of each 28-day cycle

DRUG

Olaparib

Olaparib will be administered by mouth twice a day on Days 1-28 of each 28-day cycle

DRUG

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.

DRUG

Cyclophosphamide

Cyclophosphamide will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length = 21 days)

DRUG

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